Micro dosing
Upcoming SlideShare
Loading in...5
×
 

Micro dosing

on

  • 1,868 views

 

Statistics

Views

Total Views
1,868
Views on SlideShare
1,550
Embed Views
318

Actions

Likes
2
Downloads
34
Comments
0

5 Embeds 318

http://thelaymedicalman.blogspot.com 162
http://thelaymedicalman.blogspot.in 141
http://www.thelaymedicalman.blogspot.com 7
http://www.thelaymedicalman.blogspot.in 7
http://feeds.feedburner.com 1

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

    Micro dosing Micro dosing Presentation Transcript

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