Bioequivalence and Bioavailability Forum

Dear All,

As Per the FDA Draft Guideline (Additional Comments: Applicants may consider using a reference-scaled average bioequivalence approach. Please refer to Progesterone Capsules Guidance for information regarding statistical analysis method using the reference scaled average bioequivalence approach)

We Plan to conduct the pilot Study with 2 test formulation.

So Pls suggest me which design is suitable.

Design 1: Williams’ design with T1 = test 1, T2 = test 2, R =reference
(6 sequence, 3 treatment and 3 period)

or

Design 2: Partial replicate design (T1, T2 and R (2 times)) with Four Sequence, Four Period, Three treatment. (Crossover design for four medications (Williams’ design))

1  R  T2 R  T1
2  T1 R  R  T2
3  R  T1 T2 R
4  T2 R  R  T1

Whether its possible to do Partial Replicate design like this.

Pls suggest me which design is suitable.

Thanks and Regards
k2k

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Edit: Category changed. [Helmut]