Bioequivalence and Bioavailability Forum

mmw ☆ India, 2020-04-18 15:43 (1066 d 18:26 ago) Posting: # 21334 Views: 3,958	Randomization for Replicate design studies [Design Issues] Post reply
	Dear All, Once of the clients want to conduct the partial replicate BE study with two test products (T1 & T2) in comparison with reference product (R). It would be four-period study (T1T2RR). My question is that what would be the appropriate sequences for this four period study. Your advice in this regard highly appreciated. Thanks in advance. MMW

Helmut
★★★

Vienna, Austria,
2020-04-20 14:18
(1064 d 19:51 ago)

@ mmw
Posting: # 21338
Views: 1,489

Randomization for Replicate design studies

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Hi MMW,

❝ Once of the clients want to conduct the partial replicate BE study with two test products (T1 & T2) in comparison with reference product (R).

More information, please. Will this be a pilot study where you want to select one of the candidates or a pivotal study (say, T1 is a tablet, T2 a capsule and you want to market both)?

For the former see this presentation (slide 22).
For the latter employ the same design but adjust for multiplicity (i.e., 95% CI, slide 23).
If you expect a CV_wR <43% the Type I Error might be inflated. You can iteratively adjust α (see here and there) with the R-package PowerTOST. Call scABEL.ad(alpha = 0.025, design = "2x3x3", ...), where in ... you provide the observed CV_wR and sample size (in the case of drop-outs: subjects/sequence). In case of unbalanced sequences use the argument sdsims = TRUE (slower but more accurate).

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mmw
☆

India,
2020-04-28 11:27
(1056 d 22:42 ago)

@ Helmut
Posting: # 21352
Views: 1,402

Randomization for Replicate design studies

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Hi Helmut,

Thank you for your reply

❝ More information, please. Will this be a pilot study where you want to select one of the candidates or a pivotal study (say, T1 is a tablet, T2 a capsule and you want to market both)?

This would be a pilot study with 24 subjects and using two test products (with different lot numbers). We want to select one of the test formulations for pivotal study.

Thanks

Mahesh

Randomization for Replicate design studies [Design Issues]

Randomization for Replicate design studies

Randomization for Replicate design studies