A brief presentation about the abovementioned title, it covers historical aspects, about the process of therapeutic drug monitoring, its indications, criteria, team involved and so on and so forth.
Toxicology screening and therapeutic drug monitoring (an introduction) Hossamaldin Alzawawi
Therapeutic drug monitoring (TDM) involves measuring drug concentrations in patients to optimize drug therapy and avoid toxicity. TDM emerged in the 1960s with pharmacokinetic studies linking drug levels to outcomes. Pioneers in the 1970s demonstrated that constructing therapeutic ranges could reduce adverse reactions to drugs like digoxin. TDM utilizes pharmacokinetics and pharmacodynamics to assess medication efficacy and safety. It aims to individualize treatment and tailor it to each patient's needs. Factors like genetics, disease states, and drug interactions cause vast inter-patient variability in how drugs are absorbed, distributed, and eliminated.
Therapeutic drug monitoring and shortcoming in tanzaniaPaul Mwasapi
Therapeutic drug monitoring (TDM) measures drug concentrations in patients' blood to optimize dosages. TDM is indicated for drugs with narrow therapeutic windows or variability. Common drugs monitored include aminoglycosides, antiepileptics, lithium, and digoxin. Interpretation of results considers compliance, interactions, and pharmacokinetics. TDM is underused in Tanzania due to lack of awareness, resources, and expertise, though it can improve outcomes and safety. The take-home message is that TDM ensures therapy effectiveness and safety by avoiding under- or overdosing.
The document discusses pharmacometrics and provides examples of its applications in drug development and clinical trials. It begins with definitions of pharmacometrics and related terms. It then provides examples of how pharmacometric modeling and simulation have been used to:
- Support pediatric drug approvals without the need for separate clinical trials by linking exposure to response between adult and pediatric patients.
- Optimize drug doses in clinical trials and make dosing recommendations for specific patient populations.
- Simulate clinical trials to determine trial designs and evaluate outcomes.
The document discusses repurposed drugs and safety monitoring during the COVID-19 pandemic. It describes how known drugs are being used in a different context than originally approved to treat COVID-19. Two such drugs are chloroquine/hydroxychloroquine and remdesivir. While initial studies of hydroxychloroquine showed promise in vitro, subsequent large trials found no significant benefits. Remdesivir was found to decrease recovery time based on NIH trials but the WHO recommends against its use due to low certainty of benefit. Both drugs present drug interaction risks that require careful safety monitoring.
Gentamicin is an aminoglycoside antibiotic commonly used to treat infections caused by Pseudomonas aeruginosa. It has a narrow therapeutic window, and therapeutic drug monitoring (TDM) of peak and trough plasma levels is essential to avoid toxic side effects of nephrotoxicity and ototoxicity. Gentamicin's volume of distribution is low and it is eliminated renally without metabolism. Dosing is based on creatinine clearance and body weight, with peak levels below 12 mg/L and trough levels below 2 mg/L for multiple daily doses, while once daily dosing requires different monitoring approaches.
1) Therapeutic drug monitoring (TDM) involves measuring drug concentrations in the blood to help individualize and optimize drug therapy.
2) TDM is useful when there is a narrow therapeutic range, high inter-individual variability in drug response, or when the clinical effects are not readily observable.
3) The TDM process involves requesting the test with relevant clinical information, collecting a blood sample, measuring drug concentrations using validated analytical methods, interpreting the results in the clinical context, and adjusting drug dosages based on the findings to improve therapeutic outcomes.
TDM is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. The process of TDM is predicated on the assumption that there is a definable relationship between dose and plasma or blood drug concentration, and between concentration and therapeutic effects.
Toxicology screening and therapeutic drug monitoring (an introduction) Hossamaldin Alzawawi
Therapeutic drug monitoring (TDM) involves measuring drug concentrations in patients to optimize drug therapy and avoid toxicity. TDM emerged in the 1960s with pharmacokinetic studies linking drug levels to outcomes. Pioneers in the 1970s demonstrated that constructing therapeutic ranges could reduce adverse reactions to drugs like digoxin. TDM utilizes pharmacokinetics and pharmacodynamics to assess medication efficacy and safety. It aims to individualize treatment and tailor it to each patient's needs. Factors like genetics, disease states, and drug interactions cause vast inter-patient variability in how drugs are absorbed, distributed, and eliminated.
Therapeutic drug monitoring and shortcoming in tanzaniaPaul Mwasapi
Therapeutic drug monitoring (TDM) measures drug concentrations in patients' blood to optimize dosages. TDM is indicated for drugs with narrow therapeutic windows or variability. Common drugs monitored include aminoglycosides, antiepileptics, lithium, and digoxin. Interpretation of results considers compliance, interactions, and pharmacokinetics. TDM is underused in Tanzania due to lack of awareness, resources, and expertise, though it can improve outcomes and safety. The take-home message is that TDM ensures therapy effectiveness and safety by avoiding under- or overdosing.
The document discusses pharmacometrics and provides examples of its applications in drug development and clinical trials. It begins with definitions of pharmacometrics and related terms. It then provides examples of how pharmacometric modeling and simulation have been used to:
- Support pediatric drug approvals without the need for separate clinical trials by linking exposure to response between adult and pediatric patients.
- Optimize drug doses in clinical trials and make dosing recommendations for specific patient populations.
- Simulate clinical trials to determine trial designs and evaluate outcomes.
The document discusses repurposed drugs and safety monitoring during the COVID-19 pandemic. It describes how known drugs are being used in a different context than originally approved to treat COVID-19. Two such drugs are chloroquine/hydroxychloroquine and remdesivir. While initial studies of hydroxychloroquine showed promise in vitro, subsequent large trials found no significant benefits. Remdesivir was found to decrease recovery time based on NIH trials but the WHO recommends against its use due to low certainty of benefit. Both drugs present drug interaction risks that require careful safety monitoring.
Gentamicin is an aminoglycoside antibiotic commonly used to treat infections caused by Pseudomonas aeruginosa. It has a narrow therapeutic window, and therapeutic drug monitoring (TDM) of peak and trough plasma levels is essential to avoid toxic side effects of nephrotoxicity and ototoxicity. Gentamicin's volume of distribution is low and it is eliminated renally without metabolism. Dosing is based on creatinine clearance and body weight, with peak levels below 12 mg/L and trough levels below 2 mg/L for multiple daily doses, while once daily dosing requires different monitoring approaches.
1) Therapeutic drug monitoring (TDM) involves measuring drug concentrations in the blood to help individualize and optimize drug therapy.
2) TDM is useful when there is a narrow therapeutic range, high inter-individual variability in drug response, or when the clinical effects are not readily observable.
3) The TDM process involves requesting the test with relevant clinical information, collecting a blood sample, measuring drug concentrations using validated analytical methods, interpreting the results in the clinical context, and adjusting drug dosages based on the findings to improve therapeutic outcomes.
TDM is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. The process of TDM is predicated on the assumption that there is a definable relationship between dose and plasma or blood drug concentration, and between concentration and therapeutic effects.
This document provides information on therapeutic drug monitoring, including sample information required for accurate interpretation and therapeutic ranges for various drugs. It discusses therapeutic drug monitoring for anti-seizure drugs like carbamazepine and valproic acid, cardiac drugs like digoxin and lidocaine, aminoglycoside antibiotics like amikacin and gentamicin, lithium for bipolar disorder, methotrexate for cancer treatment, theophylline, immunosuppressants for transplant patients like cyclosporine and tacrolimus, and various sample collection and testing methods. The goal of therapeutic drug monitoring is to ensure drug levels are within therapeutic ranges to achieve efficacy while avoiding toxicity.
Therapeutic drug monitoring (TDM) is a process in clinical pharmacology which specializes in measuring the concentration of certain drugs in the body fluids and clinically interpreting it to obtain useful and often lifesaving information. It is defined as “the use of drug concentration measurements in body fluids as an aid to the management of drug therapy for the cure, alleviation or prevention of disease”. TDM is done only for a few selected drugs with a narrow therapeutic range where the challenge is to avoid both sub-therapeutic and overtly toxic doses.
TDM is increasingly being used in clinical practice in order to improve the therapeutic outcome and reducing the toxicity in HIV infection.
The use of TDM requires certain criteria in order to interpret the plasma concentrations appropriately.
Indications for therapeutic drug monitoringChandra Lekha
TDM Indications ('why do it'):
Drug assays are costly, so the reason for monitoring and the additional information to be gained (if any) should be carefully considered.
For some drugs, therapeutic drug monitoring helps to increase efficacy (vancomycin), to decrease toxicity (paracetamol) and to assist diagnosis (salicylates).
Routine monitoring is not advocated for most drugs.
The appropriate indications for therapeutic drug monitoring (and examples) include:
toxicity
- diagnosing toxicity when the clinical syndrome is undifferentiated (unexplained nausea in a patient taking digoxin)
. avoiding toxicity (aminoglycosides, cyclosporin)
Only clinically meaningful tests should be performed
dosing
- after dose adjustment (usually after reaching a steady state)
- assessment of adequate loading dose (after starting phenytoin treatment)
- dose forecasting to help predict a patient's dose requirements1 (aminoglycosides)
monitoring
- assessing compliance (anticonvulsant concentrations in patients having frequent seizures)
- diagnosing under treatment (particularly important for prophylactic drugs such as anticonvulsants, immunosuppressants)
- diagnosing failed therapy (therapeutic drug monitoring can help distinguish between ineffective drug treatment, non-compliance and adverse effects that mimic the underlying disease).
The target concentration may depend on the indication. For example, the recommended concentration for digoxin depends on whether it is being used to treat atrial fibrillation or congestive heart failure.
an experimentally determined relationship between plasma drug concentration and the pharmacological effect.
• Knowledge of the drug level influences management.
In this document, there is all the information about TDM and its relation with pharmacogenetics and pharmacokinetics
TDM can be looked at as a new area in pharmacokinetics that will lead to better patient's outcomes.
Hope you enjoy it.
This document provides an overview of drug interactions, focusing on interactions involving the anticoagulant warfarin. It discusses several case reports and studies examining interactions between warfarin and nonsteroidal anti-inflammatory drugs like ibuprofen, the pain reliever acetaminophen, and steroids/the antiviral remdesivir. The mechanisms of these interactions involve effects on cytochrome P450 enzymes and vitamin K metabolism, increasing the risk of bleeding complications due to elevated INR levels when these drugs are taken concurrently with warfarin. Close monitoring of INR is recommended when patients receive any of these medications along with warfarin.
Therapeutic drug monitoring (TDM) involves measuring drug concentrations in patients to optimize dosing for efficacy and safety. TDM is useful for drugs with unpredictable relationships between dose and concentration, narrow therapeutic windows, or other pharmacokinetic factors. Key steps in TDM include deciding when to measure drug levels, collecting samples at appropriate times, measuring concentrations, interpreting results based on therapeutic ranges, and adjusting treatment accordingly. TDM aims to individualize drug therapy by achieving target concentrations for each patient.
Antibiotics requiring therapeutic drug monitoring(1)Mahen Kothalawala
This document provides information on therapeutic drug monitoring of aminoglycosides and vancomycin. It discusses pharmacokinetics concepts such as absorption, distribution, metabolism, and elimination of drugs. It explains that intravenous administration provides full bioavailability without first-pass metabolism. The document also covers pharmacodynamics predictors of antibiotic efficacy like time above MIC, AUC/MIC ratio, and Cmax/MIC ratio. It states that aminoglycosides and vancomycin require therapeutic drug monitoring due to their narrow therapeutic indices to ensure efficacy and prevent toxicity.
therapeutic drug monitoring of antibioticsPathKind Labs
Therapeutic drug monitoring (TDM) of antibiotics aims to maximize efficacy and minimize toxicity through personalized dosing. TDM involves analyzing drug concentrations in biological fluids to guide dosing. It is most useful for drugs with a narrow therapeutic index or those where concentration correlates with response or toxicity. Common antibiotics monitored include aminoglycosides, vancomycin, linezolid, and daptomycin. Pharmacokinetic/pharmacodynamic principles guide TDM by correlating drug exposure measures like Cmax/MIC and AUC/MIC with treatment outcomes.
Therapeutic drug monitoring (TDM) refers to measuring drug concentrations in plasma or blood to individualize drug dosing to maintain concentrations within a target therapeutic range. The goal of TDM is to achieve the desired beneficial effects of a drug while minimizing adverse effects. TDM is useful for drugs with a narrow therapeutic index, high inter-individual variability in drug handling, or where the relationship between concentration and response is well established. The timing of sample collection and analytical methodology used to measure drug concentrations are important considerations for effective TDM.
Therapeutic drug monitoring involves measuring drug concentrations in plasma to optimize efficacy and avoid toxicity. It aims to individualize dosing by maintaining drug levels within a target range. Some key points are:
- TDM is indicated for drugs with a narrow therapeutic index, significant pharmacokinetic variability between patients, and a clear relationship between plasma concentrations and clinical effects.
- It involves measuring drug levels, clinical interpretation considering various factors like pharmacokinetics, sampling time, drug history and clinical condition.
- Timing of plasma samples is important to obtain at steady state or just before the next dose to guide dosing adjustments.
This document discusses population pharmacokinetics and analyzing population pharmacokinetic data. It notes that while all humans are alike as a species, there are differences between populations in drug metabolism and responses. These differences are due to genetic variations between racial/ethnic groups. It describes several methods for analyzing population pharmacokinetic data, including NONMEM, which fits concentration data from all subjects simultaneously to estimate population parameters and variances, and standard two-stage methods.
Pharmacometrics is the science of using mathematical and statistical methods to characterize and predict the pharmacokinetic and pharmacodynamic behavior of drugs. It aims to improve decision making in drug development and pharmacotherapy. Pharmacometric models integrate pharmacokinetic and pharmacodynamic models to describe the relationship between drug concentration, effect, and patient characteristics. Population pharmacometric modeling is useful for characterizing variability in these parameters between individuals.
Therapeutic drug monitoring involves measuring drug concentrations in the body to aid in drug therapy management. It helps clinicians individualize treatment regimens by maintaining drug levels within the therapeutic range to provide effective and safe care. TDM is especially useful for drugs with a narrow therapeutic index, variable metabolism between patients, or those where toxicity is difficult to detect clinically. The TDM process involves deciding when to test, collecting patient information and samples, analyzing drug concentrations using various laboratory techniques, and adjusting treatment based on the results.
This document discusses therapeutic drug monitoring (TDM), including its definition, introduction, criteria for when it is useful/unnecessary, and process. TDM involves measuring drug concentrations in blood/plasma to help adjust dosages to a desired therapeutic range. It is especially useful for drugs with a narrow therapeutic index or large interindividual variability. The TDM process involves collecting a biological sample at steady state, requesting a lab analysis, the lab measuring the drug level using an appropriate analytical technique, communicating the results along with the therapeutic range, and the clinician interpreting the level based on dosage and patient factors. Commonly monitored drugs and some problems with TDM services are also mentioned.
This randomized, double-blind, placebo-controlled clinical trial tested whether a genetically-informed biomarker of nicotine metabolism (nicotine metabolite ratio or NMR) could predict responses to nicotine patch or varenicline for smoking cessation. 1246 smokers were randomized to receive placebo, nicotine patch, or varenicline. The primary outcome was 7-day point abstinence at end of treatment. For normal metabolizers, varenicline was more effective than nicotine patch, but for slow metabolizers there was no difference. Secondary outcomes and side effects also varied by treatment and NMR group. The authors concluded the NMR may help direct therapy selection to increase quit rates while decreasing side effects.
This document discusses the relationships between pharmacokinetics, pharmacodynamics, and the pharmacokinetic/pharmacodynamic relationship. It defines each term and explains the three stages: 1) the relationship between dose and drug concentrations over time (pharmacokinetics), 2) the relationship between drug concentrations in biological fluids and at the effect site (pharmacokinetic/pharmacodynamic relationship), and 3) the relationship between drug concentration at the effect site and pharmacological effects (pharmacodynamics). It also describes several pharmacodynamic models and how dose, elimination half-life, and other factors impact the duration of drug activity.
Therapeutic drug monitoring (TDM) involves measuring drug concentrations in a patient's blood to optimize drug therapy and avoid toxicity. The key objectives of TDM are to achieve the desired pharmacological effects of a drug quickly without side effects. It benefits patients medically by improving outcomes and financially by reducing costs from unnecessary hospital stays or treatment of drug-related toxicity. TDM is particularly useful for drugs with a narrow therapeutic index, those showing concentration-dependent effects, and those affected by individual patient factors like metabolism or other diseases. Common indications are lithium, digoxin, phenytoin, and antibiotics.
The document provides an overview of the Revised National Tuberculosis Control Program (RNTCP) in India. It discusses the evolution of tuberculosis (TB) control efforts from the National TB Program (NTP) to the RNTCP, which adopted the internationally recommended DOTS strategy in 1997. The organizational structure and operational guidelines of the RNTCP are also summarized. Key aspects covered include diagnostic algorithms, treatment guidelines, drug regimens, and monitoring of treatment outcomes. Special considerations for managing TB in vulnerable groups are also highlighted.
Therapeutic drug monitoring (TDM) measures drug concentrations in blood or plasma to optimize drug dosage and ensure maximum therapeutic benefit with minimal toxic effects. TDM is indicated for drugs with a narrow therapeutic index, life-threatening diseases, or those affected by individual variability. Factors like age, organ function, drug interactions, and compliance can impact drug levels. The TDM process involves collecting samples at specific times, analyzing drug concentrations using methods like chromatography, and interpreting results with clinical context to guide prescribing. Common drugs monitored include antiepileptics, immunosuppressants, and antibiotics.
This document provides information on therapeutic drug monitoring, including sample information required for accurate interpretation and therapeutic ranges for various drugs. It discusses therapeutic drug monitoring for anti-seizure drugs like carbamazepine and valproic acid, cardiac drugs like digoxin and lidocaine, aminoglycoside antibiotics like amikacin and gentamicin, lithium for bipolar disorder, methotrexate for cancer treatment, theophylline, immunosuppressants for transplant patients like cyclosporine and tacrolimus, and various sample collection and testing methods. The goal of therapeutic drug monitoring is to ensure drug levels are within therapeutic ranges to achieve efficacy while avoiding toxicity.
Therapeutic drug monitoring (TDM) is a process in clinical pharmacology which specializes in measuring the concentration of certain drugs in the body fluids and clinically interpreting it to obtain useful and often lifesaving information. It is defined as “the use of drug concentration measurements in body fluids as an aid to the management of drug therapy for the cure, alleviation or prevention of disease”. TDM is done only for a few selected drugs with a narrow therapeutic range where the challenge is to avoid both sub-therapeutic and overtly toxic doses.
TDM is increasingly being used in clinical practice in order to improve the therapeutic outcome and reducing the toxicity in HIV infection.
The use of TDM requires certain criteria in order to interpret the plasma concentrations appropriately.
Indications for therapeutic drug monitoringChandra Lekha
TDM Indications ('why do it'):
Drug assays are costly, so the reason for monitoring and the additional information to be gained (if any) should be carefully considered.
For some drugs, therapeutic drug monitoring helps to increase efficacy (vancomycin), to decrease toxicity (paracetamol) and to assist diagnosis (salicylates).
Routine monitoring is not advocated for most drugs.
The appropriate indications for therapeutic drug monitoring (and examples) include:
toxicity
- diagnosing toxicity when the clinical syndrome is undifferentiated (unexplained nausea in a patient taking digoxin)
. avoiding toxicity (aminoglycosides, cyclosporin)
Only clinically meaningful tests should be performed
dosing
- after dose adjustment (usually after reaching a steady state)
- assessment of adequate loading dose (after starting phenytoin treatment)
- dose forecasting to help predict a patient's dose requirements1 (aminoglycosides)
monitoring
- assessing compliance (anticonvulsant concentrations in patients having frequent seizures)
- diagnosing under treatment (particularly important for prophylactic drugs such as anticonvulsants, immunosuppressants)
- diagnosing failed therapy (therapeutic drug monitoring can help distinguish between ineffective drug treatment, non-compliance and adverse effects that mimic the underlying disease).
The target concentration may depend on the indication. For example, the recommended concentration for digoxin depends on whether it is being used to treat atrial fibrillation or congestive heart failure.
an experimentally determined relationship between plasma drug concentration and the pharmacological effect.
• Knowledge of the drug level influences management.
In this document, there is all the information about TDM and its relation with pharmacogenetics and pharmacokinetics
TDM can be looked at as a new area in pharmacokinetics that will lead to better patient's outcomes.
Hope you enjoy it.
This document provides an overview of drug interactions, focusing on interactions involving the anticoagulant warfarin. It discusses several case reports and studies examining interactions between warfarin and nonsteroidal anti-inflammatory drugs like ibuprofen, the pain reliever acetaminophen, and steroids/the antiviral remdesivir. The mechanisms of these interactions involve effects on cytochrome P450 enzymes and vitamin K metabolism, increasing the risk of bleeding complications due to elevated INR levels when these drugs are taken concurrently with warfarin. Close monitoring of INR is recommended when patients receive any of these medications along with warfarin.
Therapeutic drug monitoring (TDM) involves measuring drug concentrations in patients to optimize dosing for efficacy and safety. TDM is useful for drugs with unpredictable relationships between dose and concentration, narrow therapeutic windows, or other pharmacokinetic factors. Key steps in TDM include deciding when to measure drug levels, collecting samples at appropriate times, measuring concentrations, interpreting results based on therapeutic ranges, and adjusting treatment accordingly. TDM aims to individualize drug therapy by achieving target concentrations for each patient.
Antibiotics requiring therapeutic drug monitoring(1)Mahen Kothalawala
This document provides information on therapeutic drug monitoring of aminoglycosides and vancomycin. It discusses pharmacokinetics concepts such as absorption, distribution, metabolism, and elimination of drugs. It explains that intravenous administration provides full bioavailability without first-pass metabolism. The document also covers pharmacodynamics predictors of antibiotic efficacy like time above MIC, AUC/MIC ratio, and Cmax/MIC ratio. It states that aminoglycosides and vancomycin require therapeutic drug monitoring due to their narrow therapeutic indices to ensure efficacy and prevent toxicity.
therapeutic drug monitoring of antibioticsPathKind Labs
Therapeutic drug monitoring (TDM) of antibiotics aims to maximize efficacy and minimize toxicity through personalized dosing. TDM involves analyzing drug concentrations in biological fluids to guide dosing. It is most useful for drugs with a narrow therapeutic index or those where concentration correlates with response or toxicity. Common antibiotics monitored include aminoglycosides, vancomycin, linezolid, and daptomycin. Pharmacokinetic/pharmacodynamic principles guide TDM by correlating drug exposure measures like Cmax/MIC and AUC/MIC with treatment outcomes.
Therapeutic drug monitoring (TDM) refers to measuring drug concentrations in plasma or blood to individualize drug dosing to maintain concentrations within a target therapeutic range. The goal of TDM is to achieve the desired beneficial effects of a drug while minimizing adverse effects. TDM is useful for drugs with a narrow therapeutic index, high inter-individual variability in drug handling, or where the relationship between concentration and response is well established. The timing of sample collection and analytical methodology used to measure drug concentrations are important considerations for effective TDM.
Therapeutic drug monitoring involves measuring drug concentrations in plasma to optimize efficacy and avoid toxicity. It aims to individualize dosing by maintaining drug levels within a target range. Some key points are:
- TDM is indicated for drugs with a narrow therapeutic index, significant pharmacokinetic variability between patients, and a clear relationship between plasma concentrations and clinical effects.
- It involves measuring drug levels, clinical interpretation considering various factors like pharmacokinetics, sampling time, drug history and clinical condition.
- Timing of plasma samples is important to obtain at steady state or just before the next dose to guide dosing adjustments.
This document discusses population pharmacokinetics and analyzing population pharmacokinetic data. It notes that while all humans are alike as a species, there are differences between populations in drug metabolism and responses. These differences are due to genetic variations between racial/ethnic groups. It describes several methods for analyzing population pharmacokinetic data, including NONMEM, which fits concentration data from all subjects simultaneously to estimate population parameters and variances, and standard two-stage methods.
Pharmacometrics is the science of using mathematical and statistical methods to characterize and predict the pharmacokinetic and pharmacodynamic behavior of drugs. It aims to improve decision making in drug development and pharmacotherapy. Pharmacometric models integrate pharmacokinetic and pharmacodynamic models to describe the relationship between drug concentration, effect, and patient characteristics. Population pharmacometric modeling is useful for characterizing variability in these parameters between individuals.
Therapeutic drug monitoring involves measuring drug concentrations in the body to aid in drug therapy management. It helps clinicians individualize treatment regimens by maintaining drug levels within the therapeutic range to provide effective and safe care. TDM is especially useful for drugs with a narrow therapeutic index, variable metabolism between patients, or those where toxicity is difficult to detect clinically. The TDM process involves deciding when to test, collecting patient information and samples, analyzing drug concentrations using various laboratory techniques, and adjusting treatment based on the results.
This document discusses therapeutic drug monitoring (TDM), including its definition, introduction, criteria for when it is useful/unnecessary, and process. TDM involves measuring drug concentrations in blood/plasma to help adjust dosages to a desired therapeutic range. It is especially useful for drugs with a narrow therapeutic index or large interindividual variability. The TDM process involves collecting a biological sample at steady state, requesting a lab analysis, the lab measuring the drug level using an appropriate analytical technique, communicating the results along with the therapeutic range, and the clinician interpreting the level based on dosage and patient factors. Commonly monitored drugs and some problems with TDM services are also mentioned.
This randomized, double-blind, placebo-controlled clinical trial tested whether a genetically-informed biomarker of nicotine metabolism (nicotine metabolite ratio or NMR) could predict responses to nicotine patch or varenicline for smoking cessation. 1246 smokers were randomized to receive placebo, nicotine patch, or varenicline. The primary outcome was 7-day point abstinence at end of treatment. For normal metabolizers, varenicline was more effective than nicotine patch, but for slow metabolizers there was no difference. Secondary outcomes and side effects also varied by treatment and NMR group. The authors concluded the NMR may help direct therapy selection to increase quit rates while decreasing side effects.
This document discusses the relationships between pharmacokinetics, pharmacodynamics, and the pharmacokinetic/pharmacodynamic relationship. It defines each term and explains the three stages: 1) the relationship between dose and drug concentrations over time (pharmacokinetics), 2) the relationship between drug concentrations in biological fluids and at the effect site (pharmacokinetic/pharmacodynamic relationship), and 3) the relationship between drug concentration at the effect site and pharmacological effects (pharmacodynamics). It also describes several pharmacodynamic models and how dose, elimination half-life, and other factors impact the duration of drug activity.
Therapeutic drug monitoring (TDM) involves measuring drug concentrations in a patient's blood to optimize drug therapy and avoid toxicity. The key objectives of TDM are to achieve the desired pharmacological effects of a drug quickly without side effects. It benefits patients medically by improving outcomes and financially by reducing costs from unnecessary hospital stays or treatment of drug-related toxicity. TDM is particularly useful for drugs with a narrow therapeutic index, those showing concentration-dependent effects, and those affected by individual patient factors like metabolism or other diseases. Common indications are lithium, digoxin, phenytoin, and antibiotics.
The document provides an overview of the Revised National Tuberculosis Control Program (RNTCP) in India. It discusses the evolution of tuberculosis (TB) control efforts from the National TB Program (NTP) to the RNTCP, which adopted the internationally recommended DOTS strategy in 1997. The organizational structure and operational guidelines of the RNTCP are also summarized. Key aspects covered include diagnostic algorithms, treatment guidelines, drug regimens, and monitoring of treatment outcomes. Special considerations for managing TB in vulnerable groups are also highlighted.
Therapeutic drug monitoring (TDM) measures drug concentrations in blood or plasma to optimize drug dosage and ensure maximum therapeutic benefit with minimal toxic effects. TDM is indicated for drugs with a narrow therapeutic index, life-threatening diseases, or those affected by individual variability. Factors like age, organ function, drug interactions, and compliance can impact drug levels. The TDM process involves collecting samples at specific times, analyzing drug concentrations using methods like chromatography, and interpreting results with clinical context to guide prescribing. Common drugs monitored include antiepileptics, immunosuppressants, and antibiotics.
Implementation of Pharmacogenomics in community pharmacies in Alberta:Percept...Dalia A. Hamdy
- Pharmacogenomics (PGx) utilizes DNA data to predict drug response and avoid side effects, leading to personalized therapy. Mutations in drug-metabolizing enzymes can impact drug metabolism and therapeutic outcomes.
- Benefits of PGx include increased medication effectiveness and reduced costs. However, barriers to implementation include lack of healthcare provider and patient education, insurance coverage, and legislation.
- A survey of 70 pharmacists, 105 pharmacy students, and 112 patients in Alberta found that while knowledge of PGx is limited, most agree it can improve care. Pharmacists and students want more education on using PGx for patient care.
This document discusses therapeutic drug monitoring (TDM), which involves measuring drug concentrations in patients' bloodstreams to maintain optimal dosage levels. TDM aims to individualize treatment regimens by keeping drug levels within a therapeutic range. The document outlines the history, criteria, indications, and significance of TDM, as well as software used and limitations. Common drugs monitored include antiepileptics, antiarrhythmics, antibiotics, and immunosuppressants. TDM helps maximize efficacy, avoid toxicity, identify noncompliance or treatment failure, and facilitate dosage adjustments.
Meaningful Use Workgroup Recommendations Brian Ahier
The document summarizes the recommendations of the Meaningful Use Workgroup to the HIT Policy Committee regarding the objectives for Stage 2 of Meaningful Use. The Workgroup aligned the objectives with national healthcare priorities and recommended raising thresholds or expanding criteria for many Stage 1 objectives. They also proposed maintaining the current timeline but allowing a 90-day reporting period for providers to address concerns about implementation feasibility.
Drug Use Evaluation & Drug Utilisation Review (DUE & DUR)Anjali Rarichan
This document discusses drug use evaluation (DUE), medication use evaluation (MUE), and drug utilization review (DUR). DUE and MUE involve ongoing, criteria-based evaluation of drug use at the individual patient level to ensure appropriate medication use and improve outcomes. DUR also reviews medication use against criteria and can occur prospectively, concurrently, or retrospectively. The goals of these programs are to promote optimal medication therapy, ensure standards of care are met, and prevent medication-related problems through ongoing review and collaboration between healthcare providers.
Rheumatoid arthritis is a chronic autoimmune disorder that affects approximately 1% of the population. Recent advances in the management of rheumatoid arthritis include the identification of patients early in the "window of opportunity" and the addition of biologic disease-modifying agents to conventional treatments. Clinical trials have shown that aggressive targeted treatment can significantly improve outcomes for patients. The combination of methotrexate and biologics such as adalimumab leads to higher response rates and better management of symptoms over time compared to biologics alone, while risk of adverse effects remains low. With early and comprehensive treatment approaches, quality of life for rheumatoid arthritis patients can be substantially improved.
What is therapeutic drug monitoring (TDM)? Therapeutic drug monitoring (TDM) is testing that measures the amount of certain medicines in your blood. It is done to make sure the amount of medicine you are taking is both safe and effective. Not all medications require therapeutic monitoring. Most drugs have a wide therapeutic index and can be prescribed based upon pre-established dosing schedules. The effectiveness of these treatments has been evaluated, but monitoring the concentration of the drug in the blood is not required for dosing.Aminoglycoside antibiotics (gentamicin) Antiepileptics (such as carbamazepine, phenytoin and valproic acid).Why do I need TDM? You may need testing when you first start taking a medicine. This helps your provider figure out the most effective dose for you. Once that dose is determined, you may be tested regularly to make sure the medicine is still effective without being harmful.
Phase 0 & i clinical trial designing,conduct &challengesDrSatyabrataSahoo
This document discusses clinical trial phases, with a focus on Phase 0 and Phase 1 trials. It provides background on clinical trials and their history. Phase 0 trials involve microdosing to obtain early human pharmacokinetic and pharmacodynamic data before Phase 1. Phase 1 trials determine the maximum tolerated dose and safety profile of a new drug. Both phases present challenges, such as developing sensitive biomarker assays for Phase 0 and managing costs and duration for Phase 1 trials. Overall, clinical trials are essential for advancing new medical treatments.
Therapeutic drug monitoring measures drug concentrations in body fluids like plasma to help optimize drug dosage, enhance efficacy and reduce toxicity for certain drugs that have a narrow therapeutic range, variable pharmacokinetics between patients, or toxicity risks. The selection of drugs for monitoring considers factors like the relationship between concentrations and effects, an established target range, and availability of assays. Therapeutic drug monitoring aims to individualize treatment for patients based on their measured drug levels and clinical response.
This document provides an overview of microdosing and phase 0 clinical trials. It defines microdosing as using extremely low, non-pharmacologically active doses of a drug to define its pharmacokinetic profile in humans. The goals of phase 0 trials are to provide early human PK and PD data prior to phase 1 testing in order to increase the chance of successful subsequent drug development. The document describes the design, procedures, analytical techniques like LC-MS and AMS, and regulatory guidelines for microdosing and phase 0 trials.
Therapeutic drug monitoring- Descriptive questions and answers.docxDipeshGamare
Therapeutic drug monitoring (TDM) refers to measuring drug concentrations in biological fluids to optimize drug therapy for patients. TDM is useful for drugs with a narrow therapeutic index, non-linear pharmacokinetics, and a concentration-response relationship between blood levels and effects. Factors like patient demographics, dosage regimen, sampling time, and concomitant medications must be considered when interpreting TDM results to properly individualize drug dosing for each patient.
This document discusses drug utilization research. It defines drug utilization research as studying drug use and effects in populations to support rational and cost-effective drug use. The document outlines the need for drug utilization research to facilitate rational drug use. It describes different types of drug use information that can be collected, including drug-based, problem-based, patient-based, prescriber-based, and cost-based information. The document also discusses various study designs and steps involved in conducting drug utilization research studies.
PAREXEL Early Phase Clinical Research Services experts discuss developing trends in drug development including adaptive trials design, real-world data and biomarkers.
The document outlines new guidelines for TB control in India, including changes to diagnostic algorithms, case definitions, treatment regimens, and follow-up procedures. Key changes include implementing a daily drug regimen using fixed-dose combinations based on weight bands, removing the need to extend the intensive phase, and conducting long-term clinical and laboratory follow-up of patients for up to two years after completing treatment. The guidelines also provide new diagnostic and treatment approaches for drug-resistant TB, intensified case finding for vulnerable groups, and ICT-enabled adherence monitoring tools.
This document summarizes information about toxicokinetics and saturation kinetics studies presented by Shilajit Das. It discusses how toxicokinetics studies are used to evaluate systemic drug exposure in animals and relate it to dose levels and toxicity findings to assess human safety. It provides the objectives, goals and general principles of toxicokinetics studies including quantifying exposure, justifying sampling timepoints, and determining metabolites. It also discusses how saturation kinetics can cause non-linear pharmacokinetics when enzyme or carrier capacities are exceeded, and how this non-linearity can be detected by evaluating parameters like bioavailability and clearance at different doses.
Semelhante a How to set up a TDM unit dr. Shakeeb Dhorajiwala (20)
A very comprehensive, crisp, lucid presentation introducing the basics of Clinical research.
Globally recognized scientists:
1) Louis Pateur:
a. French chemist and microbiologist
b. principles of vaccination, microbial fermentation, and EPONYMOUS process of Pasteurization
c. Integral Part of our everyday life
d. germ theory of disease
e. cure for anthrax, rabies
2) Charles Darwin
a. Angry with his father Bent on proving our forefathers were monkeys
b. Descent of Man
c. Natural selection
d. Evolution
Slide 5
1. FINER criteria for research topic:
a. Feasible
b. Interesting
c. Novel does not necessarily mean that the research has not been done before. The prefix “re” in the word research implies searching again add to the existing body of knowledge
d. Ethical justification
e. Relevant
Slide 6
3) History:
a. Book of Daniel
b. King Neba-ka-nezzar
c. Wine & meat
d. Daniel & 3 fellows Legume + water diet x 10 days
4) Avicenna (10th AD)
5) Concept paper 1 paper document
Slide 9
1. Cohort Prospective, retrospective
SMART criteria:
a. Specific b. Measurable c. Achievable d. Realistic e. Time-bound
Slide 12
1. What to do: Hypothesis generation
2. Why did I begin: Intro
3. What did I do Methodology
4. What did I find: Results
5. What it means Discussion
b. Abbreviations:
a. IP- Investigational Product
Comprehensive, concise and full proof way of receiving grants to fund a research study with salient components listed below.
Covering letter: Letter to funding agencies enlisting all enclosures
1. Title page (PICOT) – upto 25 words
2. Abstract (IMRaD format) without
a. Results
b. Conclusion
3. Introduction: (FINER) upto 300 words
a. Problem statement
b. Knowledge gaps in existing scientific literature
c. Novelty
d. Societal impact
e. End with hypothesis & (SMART) Objectives: 100 words
i. Preferably 2: 1 primary and 1 or 2 secondary
4. Literature review
5. MethodologyProject Description 800 words
a. Detailed Study design, population, Sampling procedure with sample size determination, Data collection procedures, Statistics, Ethical considerations
b. Seamless connection between sections
c. Administrative part in order Institutional permissions, Bank details
6. Budget & Justification: 100 words
a. Recurring
a. Stationary
b. Equipment maintenance
b. Non-recurring
a. IEC fees
b. Bank processing charges
c. Research team Research coordinator, research assistant, research associate
7. Timeline: Gantt chart
8. References: Upto 5 upto 300 words
a. Vancouver style
b. APA
This presentation was delivered at a national conference EBCCON2023, SRM medical college, Chennai. The presentation was timed for eight minutes with two minutes of discussion. It describes evaluation of potential analgesic effect of Vitamin D3 in comparison to tramadol and diclofenac using hot plate test and acetic acid induced writhing test. Prior institutes ethics committee permission was taken and CPCSEA guidelines were followed. The study was conducted over a period of 63 days following principle of 5Rs of animal experiment. Animals were reused for two different models.
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My small effort to present an article with PPT presentation for learning purpose.
Color codes in the article PDF document:
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This was my first podium presentation presented at an international conference organized by UNESCO. The conference was remarkable because it involved superspecialty field to even nursing staff. My presentation was amongst the contenders for prize distribution. However, it did not happen so due to other presenters who outperformed me.
This particular presentation of mine covers salient features of recent drug developed for treatment of dyslipidaemia particularly familial hypercholesterolemia. This presentation also covers recent modifications in treatment guidelines.
Potassium channels are widely distributed ion channels that control a variety of cellular functions. There are several types of potassium channels including calcium-activated, inward rectifiers, voltage-gated, and two-pore domain channels. Potassium channel openers and blockers can be used to treat conditions like hypertension, arrhythmias, and diabetes by relaxing smooth muscles or prolonging cardiac repolarization.
This document summarizes research evaluating a drug for the treatment of Parkinson's disease. It describes:
1) In vitro and in vivo models used to test the drug, including studies using primary microglial cultures, rat striatal slices, and assays of dopamine stimulated adenylyl cyclase activity.
2) In vivo behavioral models to evaluate the drug's efficacy in treating Parkinsonism symptoms, such as reserpine antagonism tests, neuroleptic induced parkinsonism models, and skilled paw reaching tests.
3) The drug was evaluated using various in vitro and in vivo models to assess its ability to reduce inflammation, protect dopamine neurons from oxidative stress, and alleviate motor symptoms of Parkinson's disease
1) Tetracyclines are a class of broad-spectrum antibiotics derived from soil microorganisms. The first tetracyclines, chlortetracycline and oxytetracycline, were discovered in the 1940s-1950s.
2) Newer semi-synthetic tetracyclines like doxycycline and minocycline were developed starting in the 1950s to address problems with the older tetracyclines like resistance.
3) These newer tetracyclines have greater potency, less effect on intestinal flora, and fewer side effects compared to earlier tetracyclines.
An academic presentation on General Anesthetics, covering only the Pharmacological aspect of the drugs (ie the Pharmacokinetic and pharmacodynamic profile) available for general anesthesia. Topics not covered are different mechanisms of administering anesthesia and other basics of anesthesia.
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Osteoporosis is an increasing cause of morbidity among the elderly.
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3. Historical aspect
1960: development
of TDM principles
1970: automation of
lab methods
1980: widespread
expansion
28-01-2021
1. Patsalos PN et. al. Antiepileptic drugs—best practice guidelines for therapeutic drug monitoring: A position paper by the
subcommission on therapeutic drug monitoring, ILAE Commission on Therapeutic Strategies. Epilepsia, 49(7):1239–1276, 2008
3
World: Buchthal & Svensmark1
TDM in India: mid and late1980
Earlier effective dose establishment- Trial & error method
5. Clinical case (1/2)
• An elderly male Mr. XYZ was apparently alright 2 months back when
he experienced doubling of vision at his work place which compelled
him to return home. He felt dizzy and developed speech difficulty, gait
disturbance (ataxic gait) subsequently. The symptoms were severe to
start with and remained static. Gait disturbance has debilitated the
patient to the extent that he is now wheel-chair bound.
• Past h/o: i) neuro-surgery was done 2 years back and since then he’s
put on phenytoin 100 mg tds till now.
• ii) B/l THR 6 months back
• No h/o BA, DM, HTN, TB
28-01-2021 5
6. Case (2/2)
• Personal h/o: sleep, appetite, bladder: unaffected, chronically
constipated, chronic alcoholic and tobacco chewer but now
abstaining.
• Drug h/o: i) tab. Eptoin 100 mg tds x 2 years
• ii) tab. Diclogem sos
• Provisional diagnosis:
28-01-2021 6
7. Therapeutic Drug Monitoring (TDM)
Defn2: clinical practice involving:
• -Assays & clinical interpretation of drugs and active metabolites
in biological fluid
• -Optimize therapeutic effect
• -Minimize ADR (adverse drug reaction)
Role of TDM:
• Decrease Pk/Pd variability
• Individualization of therapy
28-01-2021
2. Maiti R. Post-graduate topics in Pharmacology.Paras Medical books<, ed.3, Hyderabad: 2020
https://www.google.co.in/search?q=therapeutic+drug+monitoring+graph&tbm=isch&ved=2ahUKEwiLt6Ohz4vuAhWzxHMBHR4hBZMQ2- 7
8. Pre-requisites for TDM
1. Availability of analytical
methods
Immunoassays
Chromatography
Gas
Liquid
2. Good correlation
plasma levels and effect
28-01-2021 8
9. Indications for TDM
1. Narrow TI
2. compliance:
to identify
Non-responders
(drug conc.<drug
dose)
Non-compliant
(drug
conc.<<drug
dose)
Fast-
metabolizers
3. Therapeutic
effect difficult to
monitor
4. High Pk
variability
28-01-2021 9
10. Drug examples
Antiepileptics e.g.
Phenytoin,
Valproic acid
Anti-arrhythmics
e.g. Digoxin,
Lignocaine
Antibiotics e.g.
Gentamycin,
amikacin
Anti-neoplastic
e.g. Methotrexate
Anti-mania e.g.
Lithium
Bronchodilators
e.g. Theophylline
Immunosuppress
ants: Cyclosporine
28-01-2021 10
11. Ideal Method
Distinguish between unchanged drug and metabolite
Sensitive
Specific- Unaffected by other drugs
Reproducible results
Short turn-around time
28-01-2021 12
13. Can TDM be done arbitrarily?
At steady state conc.- reflects levels at receptor site
• Loading dose to expedite process e.g. digoxin (t1/2: 36 h)
In case of toxicity: ASAP
• e.g. Salicylates, lithium
For short-acting drugs: both trough and peak levels large difference
• e.g. gentamicin (P – 30 mins and T-3 hrs)
Long-acting trough/peak small difference
• e.g. phenobarbitone, amiodarone (t1/2: 60 d)
Errors in timing errors in interpretation of the results3
28-01-2021 3. Kang JS, Lee MH. Overview of Therapeutic Drug Monitoring. Korean J Int Med. 2009; 24(1): 1-10 14
14. Reporting Format
Specify technique used
Conc. expressed in mass/molar units
State conc. range of drug
Clinically co-relatable
• e.g. therapeutic range of digoxin is lower in hypokalaemia
28-01-2021 15
15. Functions of TDM centre[2]
Selection of dosage regimen
Evaluate pt’s response
Assays of drug conc.
Pk evaluation of drug
Readjust dosage regimen
Formula for adjusted dose:
New dose= Previous dose x Css desired
Css measured
Monitor sr. conc.
28-01-2021 16
16. Is TDM really useful?
Useful
Narrow TI drugs
Poorly defined clinical endpoints
Drugs with saturable kinetics
major organ failure
ADR prevention
Determine drug regimen
Compliance testing
Unnecessary
28-01-2021 17
Wide TI
• e.g. CCBs,
beta blockers
Clinical outcome
unrelated to dose/
plasma conc.
Pharmacological
effect- not
quantifiable
17. TDM Process (1/2)
TDM team-
Multi-
disciplinary
• Clinical pharmacologist
• Analytical scientist
• Clinical pharmacist
Our role as
clinical
pharmacologist:
• To advise (v) about:
• Dose adjustment using nomograms
• Non-responsiveness
• Compliance
• Use AEDs in pregnancy
• Identify and manage ADRs
28-01-2021 18
18. TDM Process- 7 steps4 (2/2)
Step VII: Therapeutic management
Step VI: Clinical interpretation
Step V: Results
Step IV: Lab measurement
Step III: The request
Step II: Sampling
Step I: Decision to request
28-01-2021
4. Basalingappa S, Sharma A, Amarnath S. Basic Concepts of Therapeutic Drug Monitoring. International Journal of Current Pharmaceutical Review
and Research 2014-15, 5(4), 70-75
19
19. Nomograms (1/2)
Defn: Dose charts used to determine dosage regimen in patients on drugs
following non-linear kinetics based on:
• Pt’s demography
• Pk of drugs
• Drug plasma levels
• Creatinine clearance
Quick dosage regimen adjustment according to:
• age
• weight
• physiological states
28-01-2021 20
27. Budget: A Rough Estimate
Chromaster HPLC – nearly 4 million INR
AB SCIEX API 2000 QTRAP LCMS MS System- 3.3 lakh INR*
UFLC shimadzu- 3.3 million INR*
Area required : 300 sq. ft- 9 million INR
Other Criteria:
• Temp criteria: Requires cool ambience
• Technician
• Refrigerators for sample storage
• Waste disposal cost
Rough estimate: 20 million INR(set-up cost) + annual maintenance charges (3 million INR)
28-01-2021
*https://www.google.co.in/search?sxsrf=ALeKk01Xiz5-
GwKsv9xHkbasNlrPubMmg:1611509424659&q=AB+SCIEX+API+2000+QTRAP+LC+MS+MS+System+cost&spell=1&sa=X&ved=2ahUKEwi89ru2jLXuAhUegdgFHc64DtQQBSgAegQIAxA1&biw=1
366&bih=663
28
28. Pros of Setting up TDM Facility
Determinant of dose of formulation5
• e.g. phenytoin 30 mg
Improvise standard dose recommendation
• e.g. standard paediatric dose of phenytoin (10–15 mg kg−1) was found to yield suboptimal
plasma levels6
Clinical malpractice viz prescribing irrational and dangerous combinations can
picked up
• e.g. Ca2+ tabs+phenytoin, proconvulsant anti-bacterials to epileptics
28-01-2021
5. Kshirsagar NA, Joshi MV, Shah PU, Dalvi SS. Need for25 mg tablets of phenytoin. J Assoc Phys Ind 1991; 39: 395–396
6. Rane CT, Gogtay NJ, Kadam VS, Powar HS, Dalvi SS, Kshirsagar NA. Subtherapeutic levels of phenytoin with standard doses in infants: need to review dosage schedule. Br J Clin Pharmacol 1999; 48: 465–466
https://www.google.co.in/search?q=phenytoin+formulations&sxsrf=ALeKk02fAo2ltz4JtxrFrAbwH9taXRBBJA:1610686026422&source=lnms&tbm=isch&sa=X&ved=2ahUKEwjr-
MuDkZ3uAhVPzzgGHfi7ArAQ_AUoAXoECAIQAw&biw=1517&bih=736#imgrc=cRla8zNznFCFyM
29
29. Limitations[2]
Limited no. of drugs
Doubtful scientific accuracy of assays
• Active metabolites carbamazepine-10,11-epoxide therapeutic response not
routinely measured
Variability in reporting
• ideal laboratory turnaround time<dosing interval
• due to cost, tested in batches lengthen turnaround time
Limited access
28-01-2021
Maiti R. Post-graduate topics in Pharmacology. Paras Medical books, ed.3, Hyderabad: 2020
30
30. What future holds for TDM (1/2)[7]
potential to improve patient outcomes and drastically reduce healthcare
costs
sensor-based approaches not yet fully explored
• E.g. i) LC with sensors
• ii) UPLC-MS: simultaneous quantification of multiple anti-microbials from different
samples
Orbitrap technology: high mass resolution measurements over wider
concentration ranges
28-01-2021 7. Ates HC et al. On-Site Therapeutic Drug Monitoring. Trends in Biotechnology, November 2020, Vol. 38, No. 11 31
31. Future of TDM (2/2)
Biosensor: analytical device
converts biological response
quantifiable signal via molecular
recognition using bioreceptors
Microneedles
28-01-2021 7. Ates HC et al. On-Site Therapeutic Drug Monitoring. Trends in Biotechnology, November 2020, Vol. 38, No. 11 32
32. Challenges encountered in developing countries
Alternative systems of medicine
Paucity of quality control (QC) measures- lab
accreditation/ external QC
Financial : Set-up pays to overseas QC
programmes
28-01-2021 33
33. Conclusion
A useful adjunct tool for clinicians
provides greater insight into factors determining patients’ response to drug therapy
helps tailor drug dose and regimen as per clinical condition of patient leads to drug optimization
TDM cannot compensate for error in:
•diagnosis
•poor choice of drugs
•errors in dispensing medication
•non compliance
However, when used in combination with good clinical observation, it can lead to optimal drug
therapy with minimal side effects.
28-01-2021 34
Trough levels: drug in elimination phase- least variable point in the dosing interval is just before the next dose is due
digoxin monitoring should not
be performed within six hours of a dose, because it will still be
undergoing distribution and so plasma concentrations will be
erroneously high