Micro dosing

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Micro dosing

  1. 1. Microdosing<br />Dr.Sangeetha<br />
  2. 2. Microdosing / Phase 0 studies<br />A new method in Drug development<br />Testingmicrodoses of drug in humansprior to phase 1 studies<br />Aim: to obtainearlyhuman PK data..<br />
  3. 3. WHY MICRODOSING ? ?<br />
  4. 4. Stages of drug development<br />
  5. 5. Stages of drug development<br />.<br />Drug discovery<br />Drug candidate<br />Animal studies<br />Preclinicaldevelopment<br />phase1<br />Clinicaldevelopment<br />Phase 2<br />Post marketing surveillance<br />Phase 3<br />
  6. 6. Stages of drug development<br />.<br />Drug discovery<br />5 YEARS<br />Preclinical development<br />1YEAR<br />5 YEARS<br />Clinical devpmt<br />1YEAR<br />Post marketing surveillance<br />
  7. 7. Drug development<br />Complex,timeconsuming,costly<br />12 years<br />½ -1 billion $ / Drug!<br />Only 1/50 projectssucceed<br />So steadydecline in new drugs..<br />
  8. 8. Stages of drug development<br />
  9. 9. Common reasons for failure<br />Problems in <br />safety<br />efficacy<br />Toxicology<br />Earlyhuman PK data is essential..<br />
  10. 10. Current scenario<br />Animal models<br />Bioavailability<br /> Phase2 conjugationpathways<br />Wrong data in 1out of 3 occasions !<br />
  11. 11. MICRODOSE / PHASE 0<br />
  12. 12. Microdose<br />Definition<br /> 1/100th of the clinical dose as determinedfrom animal studies or 100 μg of drug<br />
  13. 13. .<br />AIM: to obtainearlyhuman PK data/ADME data<br />No safety or efficacy data..<br />PREREQUISITE:Radioisotopes , Ultra sensitive analyticalmethodslikeAMS & PET.. <br />
  14. 14. The method<br />.<br />Microdose labeled with RADIOISOTOPE <br />PET<br />AMS<br />Stages of drug development<br />IMAGING TECHNIQUE<br />ESTIMATE THE QUANTITY<br />PD DATA<br />PK DATA<br />
  15. 15. ACCELERATOR MASS SPECTROMETRY<br /> Type of mass spectrometry<br /> Mass/Charge ratio<br /> AMS<br /> Qualitative<br /> Quantitative <br />Pharmacokinetic Data.. <br />
  16. 16. Positron emission tomography<br />Non invasive imaging technique<br />Find out the chemical functioning of organs<br />So gives Pharmacodynamic data..<br />
  17. 17. BENEFITS<br />Help find out the best drug candidate for phase1 studies<br />↓ses the attrition rate in next phase<br />Avoids the exposure of humans to drugswithuncertainsafety & kinetics<br />The likely dose..<br />
  18. 18. Disadvantages<br />Microdosemay not predict the action atclinical dose<br />No safety data<br />Costlyequipment<br />Doesnt trace the drug..only isotope..<br />Costeffectiveness ??<br />
  19. 19. SUMMARY <br />An innovation in drug research<br />Better PK data<br />Better Phase 1 studies<br />Sophisticated equipment<br />Need further studies<br />
  20. 20. Title<br />

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