Three Formulation - Partial Replicate [RSABE / ABEL]
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))
Whether its possible to do Partial Replicate design like this.
Pls suggest me which design is suitable.
Thanks and Regards
k2k
Edit: Category changed. [Helmut]
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
Edit: Category changed. [Helmut]
Complete thread:
- Three Formulation - Partial ReplicateK2K 2013-10-18 10:05 [RSABE / ABEL]
- Three Formulation - Partial Replicate vinayshed 2013-10-28 08:42
- Randomization? Helmut 2013-10-28 12:11
- Randomization? vinayshed 2013-10-28 14:47
- Randomization? Helmut 2013-10-28 15:09
- Randomization? K2K 2013-10-29 10:10
- not randomized! Helmut 2013-10-29 13:14
- not randomized! K2K 2013-10-31 10:08
- CVwr Helmut 2013-10-31 16:25
- not randomized! K2K 2013-10-31 10:08
- not randomized! Helmut 2013-10-29 13:14
- Randomization? K2K 2013-10-29 10:10
- Randomization? Helmut 2013-10-28 15:09
- Randomization? vinayshed 2013-10-28 14:47
- Randomization? Helmut 2013-10-28 12:11
- Three Formulation - Partial Replicate vinayshed 2013-10-28 08:42