Bioequivalence and Bioavailability Forum

Dear all please Suggest me,

As all of you aware that

Full replicate design and partial replicate design are recommended to demonstrate bioequivalence for high variable drugs.

Please suggest me about the following:

1. The best design out of Full replicate / partial replicate.
   
2. Basis for selection of design for pivotal in case intra subject CV is above 30% – means what should be looked at in the pilot data for design selection – ratio, power or 90%CI observed
   
3. Advantages of Full replicate over partial replicate and vice versa.
   
4. Disadvantages of both designs.

Regards
Kotu

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Edit: Category changed. [Helmut]