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Lawrence X. Yu, Ph.D.

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Bioequivalence of Highly Variable Drugs (30 min) Barbara Davit, Ph.D., Sam Haidar, Ph.D. ... FDA's Proposal on HVD Barbara Davit, Ph.D. ... – PowerPoint PPT presentation

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Title: Lawrence X. Yu, Ph.D.


1
Bioequivalence of Highly Variable Drugs
  • Lawrence X. Yu, Ph.D.
  • Director for Science
  • Office of Generic Drugs, OPS, CDER, FDA
  • ACPS Meeting, October 6, 2006

2
2004 ACPS MeetingBioequivalence of Highly
Variable Drugs
  • Introduction (5 min) Lawrence Yu, Ph.D.
  • Why Bioequivalence of Highly Variable Drugs Is an
    Issue? (20 min) Charlie Diliberti, Barr Lab
  • Highly Variable Drugs Sources of Variability (20
    min) Gordon L. Amidon, Ph.D.
  • Clinical Implications of Highly Variable Drugs
    (20 min) Leslie Benet, Ph.D.
  • Bioequivalence Methods for Highly Variable Drugs
    (20 min) Laszlo Endrenyi, Ph.D.
  • Bioequivalence of Highly Variable Drugs (30
    min) Barbara Davit, Ph.D., Sam Haidar, Ph.D.
  • BE of HV Drugs Q A Dale Conner, Pharm.D.

3
2004 ACPS Recommendation
  • The Committee emphasized that Highly Variable
    (HV) drugs focus on HV drug product
  • The Committee suggested the need to understand
    where the variability originated.
  • The members agreed that the use of reference
    scaling and good scientific methods could reduce
    the variability in the short term...
  • In conclusion, the Committee agreed that a limit
    on the point estimate should also be used along
    with reference scaling.

4
Sources of Variability
  • Drug substance
  • Drug product
  • Bioequivalence study
  • Physiological factors

5
Therapeutic Equivalence
  • Designed to be equivalent (Pharmaceutical
    Equivalent) Demonstrate bioequivalence
    Therapeutic Equivalent
  • Understanding sources of variability will
    facilitate product design and bioequivalence
    demonstration
  • To demonstrate bioequivalence, in vivo
    bioequivalence study is often necessary

6
Bioequivalence of Highly Variables Drugs
  • Mechanistic understanding of sources of
    variability
  • Challenges to demonstrate BE for highly variable
    drugs remain

7
2006 ACPS MeetingBioequivalence of Highly
Variable Drugs
  • Topic Introduction (10 min) Lawrence Yu,
    Ph.D.
  • Therapeutic Considerations of HVD (25
    min) Leslie Benet, Ph.D.
  • Bioequivalence of HVD (25 min) Kamal K.
    Midha, PhD.
  • Evaluation of a Scaling Approach for HVD (25
    min) Sam Haidar, PhD
  • FDAs Proposal on HVD Barbara Davit,
    Ph.D.
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