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SOME FEATURES, ISSUES, AND PROBLEMS OF INDIVIDUAL BIOEQUIVALENCE

SOME FEATURES, ISSUES, AND PROBLEMS OF INDIVIDUAL BIOEQUIVALENCE. Laszlo Endrenyi and Laszlo Tothfalusi University of Toronto. FDA/CDER Advisory Committee for Pharmaceutical Science November 29, 2001 . BEHAVIOR OF INDIVIDUAL BE.

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SOME FEATURES, ISSUES, AND PROBLEMS OF INDIVIDUAL BIOEQUIVALENCE

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  1. SOME FEATURES, ISSUES, AND PROBLEMS OF INDIVIDUAL BIOEQUIVALENCE Laszlo Endrenyi and Laszlo Tothfalusi University of Toronto FDA/CDER Advisory Committee for Pharmaceutical Science November 29, 2001

  2. BEHAVIOR OF INDIVIDUAL BE Individual BE has, in practice, unfavorable properties Acceptance or rejection can be due to random chance alone

  3. HIGHLY-VARIABLE DRUGS Replicate design is recommended Analysis outlined in Guidances: only by scaled individual BE But: scaled average BE is much more effective

  4. For the comparison of means: Scaled average BE [scABE4] is much more effective than scaled individual BE [scIBE4] (smaller consumer and producer risks)

  5. When two criteria are applied jointly, the rate of acceptance is less than that of either component criterion alone; e.g., scaled individual BE [scIBE 4] and GMR=1.25 [GMR_limit] In this case, the joint criterion [GIBE 4_sc] is essentially a GMR criterion

  6. CONSTRAINT ON RATIO OF GEOMETRIC MEANS (GMR)

  7. FIRST SET OF CONCLUSIONSON INDIVIDUAL BIOEQUIVALENCE

  8. BE OF MODIFIED-RELEASE (MR)FORMULATIONS

  9. BE OF MODIFIED-RELEASE (MR)FORMULATIONS

  10. SUBJECT-BY-FORMULATIONINTERACTION (S*F)

  11. DATA ANALYSIS &STATISTICAL METHODOLOGYSuggested projects

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