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Bioequivalence of Highly Variable Drugs

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. 2004 ACPS Meeting Bioequivalence of Highly Variable Drugs. Introduction (5 min) Lawrence Yu, Ph.D.

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Bioequivalence of Highly Variable Drugs

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  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 • FDA’s Proposal on HVD Barbara Davit, Ph.D.

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