Topic 3 acps questions highly variable drugs
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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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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

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)


Topic 3 acps questions highly variable drugs

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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