2. Microdosing / Phase 0 studies A new method in Drug development Testingmicrodoses of drug in humansprior to phase 1 studies Aim: to obtainearlyhuman PK data..
5. Stages of drug development . Drug discovery Drug candidate Animal studies Preclinicaldevelopment phase1 Clinicaldevelopment Phase 2 Post marketing surveillance Phase 3
6. Stages of drug development . Drug discovery 5 YEARS Preclinical development 1YEAR 5 YEARS Clinical devpmt 1YEAR Post marketing surveillance
12. Microdose Definition 1/100th of the clinical dose as determinedfrom animal studies or 100 μg of drug
13. . AIM: to obtainearlyhuman PK data/ADME data No safety or efficacy data.. PREREQUISITE:Radioisotopes , Ultra sensitive analyticalmethodslikeAMS & PET..
14. The method . Microdose labeled with RADIOISOTOPE PET AMS Stages of drug development IMAGING TECHNIQUE ESTIMATE THE QUANTITY PD DATA PK DATA
15. ACCELERATOR MASS SPECTROMETRY Type of mass spectrometry Mass/Charge ratio AMS Qualitative Quantitative Pharmacokinetic Data..
16. Positron emission tomography Non invasive imaging technique Find out the chemical functioning of organs So gives Pharmacodynamic data..
17. BENEFITS Help find out the best drug candidate for phase1 studies ↓ses the attrition rate in next phase Avoids the exposure of humans to drugswithuncertainsafety & kinetics The likely dose..
18. Disadvantages Microdosemay not predict the action atclinical dose No safety data Costlyequipment Doesnt trace the drug..only isotope.. Costeffectiveness ??
19. SUMMARY An innovation in drug research Better PK data Better Phase 1 studies Sophisticated equipment Need further studies
