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Student Name: Jayshri Uddhav Naikwadi
B. Pharmacy Semester-VII
Department: -Pharmacology

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Sr. No. Content
01. Module –I Experimental Pharmacology Technique
02. Module-II Toxicity Study
03. Module-III Pharmacovigilance

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Histamine Chamber
Principle:-
A compact Histamine aerosol apparatus consisting of a clear perspex exposition chamber divided n two sections, with glass
ncubilizer with rubber below, dial type sphygmomanometer for assay of anti-histamines drug on guinea-pigs etc.
Applications
For assay of antihistamine drug on guinea pig.

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Digital Actophotomete
Principle:-
Most of the CNS acting drugs influence the locomotor activities in man & animals.
Applications:-
To measure locomotor activity (horizontal movement) of animals.
Student Organ Bath
Principle:-
Isolated organs or tissues can be administered with drugs, or stimulated electrically, in order to measure their function.
Application:-
To investigate the physiology and pharmacology of in-vitro tissue preparation.

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Sherington Rotating Drum
Principle:-Consists of a revolving drum wrapped with a sheet of paper on which a stylus moves back and forth
recording perceived changes of phemenon.
Application:-
To measure atmospheric pressure, tuning fork vibrations and functioning of steam engines.
Open Field Apparatus
Principle:-
The open field is usually an enclosed space, which may be square, circular in shape with surrounding walls that
prevent the animal from escaping.
Applications:-
To provide a qualitative and quantitative measurement of exploratory and locomoter activity in rodents.

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Frog (Rana tigrina)
Weight:-150 – 200gm
Use
Study of muscle nerve prenominon and cillary movement, perform pregnancy test and experimental with
clonig
Rabbit(Domestic Rabbit)(Oryctolaguscuniculus)
Weight:-2-3 kg
Use:-
Pyrogen testing, to produce serum antibodies,Biomedical research and antibody development.

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Albino Rat (Rattus norvegicus)
Weight:-200gm
Use:-
Radio receptor ligand study,fasting study to measure the quality to proteins inside the body.
Albino Mouse (Mus musculus)
Weight:- 25-30gm
Use:-Toxicity study and bio assay of drug, most widely used as inbred strains used in animal experimentation.
Guinea Pig (Cavia porcellus)
Weight:-400-600gm

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.The Typical “relaxed rat” position.
 Holding neonates in the cupped
Removing a rat from the cage by the base of tail
Restraing a neonate between thumb and fingers
Head controlled using the thumb
Grasping a rat around its body to remove it from the cage
Using the tail method of restraint to sex a rat
.The rat is positioned the body of the handler whilst a restraining grip is taken
Head controlled by crossing the front

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Blood Collection from Tarsal Vein
Blood Collection from Saphenous Vein
Blood Collection From Veni puncture
Blood collection from blood vessel cannulation
Blood collection from cavia porcellus vein
Blood collection from Gingival

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• Aim: To study the muscle relaxant property by using rota rod apparatus.
• Requirements
Animal: Mice (20-25 g)
Drug: Diazepam (Dose 4mg/kg, ip; prepared a stock solution containing 0.4mg/ml of the drug and inject
1ml/100gm of body weight of the mouse. diazepam is suspended in 1%w/v gum acacia or
carboxymethylcellulose).
• Principle:
One of the important pharmacological action of anti-anxiety agent of benzodiazepine class of drug
in muscle relaxant property. The skeletal muscle relaxation together with taming or claming effect, these reduce
anxiety and tension. The loss of muscle-grip is an indication of muscle relaxation. This effect can be easily
studied in animals using inclined plane and rotating rods.

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• Procedure:
 Weight the animals and number them.
 Turn on the rota-rod select an appropriate speed (20-25rmp is ideal).
 Place the animal one by one the rotating rod (If the rod is divided into several compartments, one can place
more than one mouse of a time). Note down the “Fall Off Time” when the mouse Fall from the rotating rod.
A normal mouse generally falls off within 3-5 minutes.
 Inject diazepam (4mg/kg) to all animals. After 30 min repeat the experimental as done in step 3 Note the fall
off time.
 Compare the fall off time of animals before and after diazepam treatment.

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• Observation Table
Sr no. BW (gm) Dose to be administered
Fall time
Decrease in fall time A-B/
A relaxant
Basal Treatment
1 25 0.1 66 5 92.72
2 30 0.12 60 8 86.66
3 32 0.128 61 6 90.16
4 35 0.14 62 5 91.33
5 33 0.132 63 8 87.3
• Result:- Treatment of diazepam decreases time spends on rota rod hence it may be shown muscle relaxant property

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INTRODUCTION
The traditional definition of toxicology is "the science of poisons.
Toxicology is a field of science that helps us understand the harmful effects that chemicals, substances, or situations, can have on
people, animals, and the environment.
Toxicology is the study of how natural or man-made poisons cause undesirable effects in living organisms.
HISTORY OF TOXICITY STUDIES
The history of toxicity studies begins with Paracelsus (1493–1541), who determined specific chemicals responsible for the
observed toxicity of plants and animals.
He demonstrated the harmless and beneficial effects of toxins and proved dose-response relationships for the effects of drugs.
The study and classification of toxic substances was first systematized by MatthieuOrfila (1787–1853) in the 19th century.
GUIDELINE FOLLOWED
• International Conference On Hormonization (ICH)
• Organization For Economic Co-Operation And Development (OECD)
• Food And Drug Administration (FDA)
• European Mediciency Agency (EMEA)

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• 401 -Acute Oral Toxicity.
• 402- Acute Dermal Toxicity.
• 403 -Acute Inhalation Toxicity.
• 404 -Acute Dermal Irritation/Corrosion.
• 405 -Acute Eye Irritation/Corrosion.
• 406 -Skin Sensitisation.
• 407 -Repeated Dose 28-day Oral Toxicity Study in Rodents.
• 408 -Repeated Dose 90-Day Oral Toxicity Study in Rodents.
• 409 -Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents .
• 411 -Sub chronic Dermal Toxicity: 90-day Study.
• 420- Acute Oral Toxicity – Fixed Dose Procedure.
• 421 -Reproduction/Developmental Toxicity Screening Test.
• 423- Acute Oral toxicity – Acute Toxic Class Method.
• 424 -Neurotoxicity Study in Rodents.
• 425 -Acute Oral Toxicity: Up-and-Down Procedure..
• 451 - Carcinogenicity Studies
• 452 - Chronic Toxicity.

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• Animal – Guinea Pig
• Route of administration – Intradermal injection
• Sex – male female should be nulliparous and non pregnant
• Body weight – 250-500gm
• Photoperiod – 12 hour dark and 12hour light
• Feeding –Conventional laboratory diet
• Acclimatization –at least 5 days prior to the test
• 1.Acute Toxicity
• 2.Chronic Toxicity
• 3.Sub-chronic toxicity

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• Pharmakon (Greek) = Medicinal Substances
• Vigilia (Latin) = To keep watch
• Pharmacovigilance is the science &activities relating to the detection, assessment, understanding and prevention of adverse
effects (WHO collaborating centre for international drug monitoring)
• AIMS OF PHARMACOVIGILANCE :
• Improve patient care and safety in relation to the use of medicines and all medical and paramedical intervention.
• Improve public health and safety in relation to the use of medicines.
• Contribute to the assessment of benefits , harm , effectiveness and risk of medicines.
• Detection:In case of clinical trial, it’s the investigator or in case of post marketing trial, it’s either the physician or the
prescriber or the patient himself who reports the adverse event or any drug related problem.
• Assessment: The investigator or the health care professional (HCP) would be assessing if the adverse
• event or drug related problem is due to the drug or is it due to some other reason.
• Understanding:The reporter and safety specialist is involved in the understanding the adverse event or drug related
problem.
• Prevention: By pro-actively reporting the adverse event or drug related problem to the regulatory authority and taking
precautionary actions would help in preventing the adverse event in future. Major Aims of Pharmacovigilanace.

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• TERMINOLOGIES USED IN PHARMACOVIGILANCE :
WHO – ART :
• Terminology for coding clinical information in relation to drug therapy . WHO – ART is maintained by UMC
VIGIBASE :
• The main features include the disproportionality measure stratified in different ways and useful filter capabilities.
SIDE EFFECTS :
• Any unintended effect of a pharmaceutical product occurring at normal dosage which is related to the pharmacological
properties of the drug.
• RATIONAL DRUG USE :
Rational drug use medicines requires that "patients receive medications appropriate to their clinical needs, in doses that meet
their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community.
• OTC ( OVER THE COUNTER):
Drugs which are legally allowed to be sold by pharmacists without need for a prescription.
• COMPLIANCE :
It means knowing what the rules are and following them.
DECHALLENGE :
De-challenge is positive when after removal of the drug the adverse event subsides or disappears. A de-challenge is negative
when the event persists even after removal of the drug i.e. a causal relationship is unlikely.

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 INDIVIDUAL CASE SAFETY REPORT:
The individual case study report (ICSR) is an adverse event report for an individual patient and is the source of data in
pharmacovigilance. The main focus of ICSRs are reports from healthcare providers and patients in member countries of the
WHO Programme.
RECHALLENGE :
The point at which a drug is given again to a patient after its previous withdrawal.
CLINICAL TRIAL:
A type of research study that tests how well new medical approaches work in people. These studies test new methods of
screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.
ADVERSE DRUG INTERACTION :
An adverse drug reaction (ADR) can be defined as 'an appreciably harmful or unpleasant reaction resulting from an intervention
related to the use of a medicinal product
• WHAT TO REPORT
• Who Can Report
• Where To Report
• What happened to submitted informstion
• Reason for monitoring

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• REPORTING SYSTEM
• SPONTANEOUS REPORTING :
• A spontaneous report is an unsolicited communication by a healthcare professional or consumer to a company, regulatory
authority or other organization (e.g. WHO, Regional Center, Poison Control Center) that describes one or more adverse drug
reactions in a patient who was given one or more medicinal products.
• -Involve a serious and unlisted event.
• -The time frame for reporting expedited cases
• -7/15 calendar days
• -Within clinical trials - SUSAR (a Suspected Unexpected Serious Adverse Reaction).
• -SUSAR, life-threatening or fatal, subject to a 7-day "clock”
• -Review the Requirements for Reporting Results. Review the Results Data Elements Definitions to understand what
information is required.
• -Complete the Results Modules.
• -Upload Supplemental Documentation.
• -Release the Record.
• -Address PRS Review Comments.

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• -Also known as periodic reporting.
• -Key role in the safety assessment of drugs.
• -Compilation of safety data for a drug over a prolonged period of time ( months or years) – ( broader view )
• -Example : PSUR.
• This service area covers the processing of individual case safety reports (ICSRs) originating from
• various sources:
• -Post-marketing non-solicited/Spontaneous reports
• -Clinical reports
Significance of Pharmacovigilance
• Improve communication between the health professionals and the public;
• Educate health professionals to understand the effectiveness/risk of medicines that they
• This is the significance role pharmacovigilance
• Pharmacovigilance remains a dynamic clinical and scientific discipline