mmw
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India,
2020-04-18 13:43
(224 d 05:13 ago)

Posting: # 21334
Views: 3,158
 

 Randomization for Replicate design studies [Design Issues]

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
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Vienna, Austria,
2020-04-20 12:18
(222 d 06:38 ago)

@ mmw
Posting: # 21338
Views: 806
 

 Randomization for Replicate design studies

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 CVwR <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 CVwR 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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Helmut Schütz
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mmw
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India,
2020-04-28 09:27
(214 d 09:29 ago)

@ Helmut
Posting: # 21352
Views: 729
 

 Randomization for Replicate design studies

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
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