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FDA Advisory Committee Pharmaceutical Sciences November 29, 2001

Individual Bioequivalence: Strengths and Weaknesses of the Current Approach: View from the Generic Pharmaceutical Association by MDS Pharma Services. Mario Tanguay, BPharm, PhD Associate Director, Pharmacokinetics. FDA Advisory Committee Pharmaceutical Sciences November 29, 2001.

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FDA Advisory Committee Pharmaceutical Sciences November 29, 2001

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  1. Individual Bioequivalence: Strengths and Weaknessesof the Current Approach:View from theGeneric Pharmaceutical Associationby MDS Pharma Services Mario Tanguay, BPharm, PhD Associate Director, Pharmacokinetics FDA Advisory Committee Pharmaceutical Sciences November 29, 2001

  2. Individual BioequivalenceCollaborators • GPhA Science and CRO/Biopharmaceutics Committees • MDS Pharma Services • Murray P. Ducharme, PharmD, FCCP, FCP • Marika Pasternyk DiMarco, MSc, PhD • Diane Potvin, MSc

  3. Individual BioequivalenceAdvantages of IBE • Enables one to capture the advantages of giving the same formulation twice • Replicate design has no real benefit when ABE is used • IBE may be ethically advantageous • Smaller sample size needed for highly variable drugs due to the scaling component

  4. Individual BioequivalenceDisadvantages of IBE • How robust is the assessment of switchability with current IBE approach? • BE studies are primarily designed to prove bioequivalence based on Cmax and AUCs calculations • Current BE studies are not designed to allow proper determination of a Subject * Form interaction • Reason(s) for Subject * Form interaction cannot be identified properly

  5. Individual BioequivalenceDisadvantages of IBE • Enrollment of a heterogeneous population may not be helpful • BE Studies are not properly designed to evaluate • Gender differences in PK • Age differences in PK • Race differences in PK • etc...

  6. Individual BioequivalenceDisadvantages of IBE • In clinical research, conclusions based on posteriori statistical subgroup evaluations have many times been proven to be wrong when verified in properly designed prospective studies. • These lessons should apply to switchability measurement in BE studies

  7. Individual BioequivalenceConclusion • The BE of 2 formulations of a highly variable drug will be better assessed by giving a formulation more than once to the same subject • However, it is not appropriate to assume that switchability is robustly assessed with IBE • Posteriori subgroup calculations (study not designed for this) • Contrary to the lessons we have learned over the years in Clinical Pharmacology

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