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Topic 3: ACPS Questions Highly Variable Drugs

Topic 3: ACPS Questions Highly Variable Drugs. FDA/CDER ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS). Topic 3 Question 1: . Does the committee agree with the use of a point estimate constraint when applying scaled bioequivalence? If yes, is the 80 –

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Topic 3: ACPS Questions Highly Variable Drugs

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  1. Topic 3: ACPS Questions Highly Variable Drugs FDA/CDER ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

  2. Topic 3 Question 1: Does the committee agree with the use of a point estimate constraint when applying scaled bioequivalence? If yes, is the 80 – 125% limit on the point estimate appropriate? FDA/CDER ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

  3. We propose a minimum sample size of 36 subjects when evaluating the BE of highly variable drugs. Does the Committee concur? Topic 3 Question 2: FDA/CDER ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

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