Microdosing for Early Drug Development
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Microdosing for Early Drug Development
- 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..
- 3. WHY MICRODOSING ? ?
- 4. Stages of drug development
- 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
- 7. Drug development Complex,timeconsuming,costly 12 years ½ -1 billion $ / Drug! Only 1/50 projectssucceed So steadydecline in new drugs..
- 8. Stages of drug development
- 9. Common reasons for failure Problems in safety efficacy Toxicology Earlyhuman PK data is essential..
- 10. Current scenario Animal models Bioavailability Phase2 conjugationpathways Wrong data in 1out of 3 occasions !
- 11. MICRODOSE / PHASE 0
- 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
- 20. Title