Bioequivalence and Bioavailability Forum 15:12 CET

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Example for discussion [Power / Sample Size]

posted by mittyri - Russia, 2017-12-28 22:06  - Posting: # 18120
Views: 11,533

Dear Detlew, Dear Helmut,

Let me play the devil’s advocate.
Let's say you have to register some new generic pharmaceutical product and you have the data of pilot study which says that GMR is about 115% with CV about 20% (n=20). The ISCV data is mainly in accordance with literature sources (18-26%).

Again, a man in Harmani suite as your Boss says it MUST be registered and you have only current product to test. So you are interested to register the drug (to show the bioeqivalence).
What would be your recommendation for sample size? How would you estimate it?

Kind regards,
Mittyri

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