balakotu
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India,
2012-04-02 17:18
(5189 d 22:36 ago)

Posting: # 8366
Views: 5,214
 

 Calculation for partial and full replicate designs [Power / Sample Size]

Dear All,

How to calculate Sample Size for Partial and full replicate study designs for Europe and USA Regulatory is there any softwares plz post me name of the softwares, any knows SAS program (sample size calculation) for pratial or fully replicate study designs plz post me.

Regards
Kotu


Edit: Category and subject line changed. [Helmut]
Helmut
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Vienna, Austria,
2012-04-02 18:28
(5189 d 21:26 ago)

@ balakotu
Posting: # 8368
Views: 4,265
 

 Lászlós’ tables

Dear Koto!

We have answered you already to a very similar post of yours. Either you use the tables given there* or you set up your own simulations (good luck). We already pointed out that this task is not possible in SAS! You need a faster programing environment (MATLAB or at least FORTRAN, C/C++).


  • Endrényi L, Tóthfalusi L. Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs
    J Pharm Pharmaceut Sci. 2011;15(1):73–84. online

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jag009
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NJ,
2012-04-02 18:48
(5189 d 21:06 ago)

@ balakotu
Posting: # 8369
Views: 4,291
 

 Calculation for partial and full replicate designs

Hello,

Powertost (R) can determine the sample size for you (for 3-way rep) if you have the CV, pt estimate, no?


Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Helmut
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Vienna, Austria,
2012-04-02 21:06
(5189 d 18:49 ago)

@ jag009
Posting: # 8371
Views: 4,252
 

 Calculation for partial and full replicate designs

Dear John!

❝ Powertost (R) can determine the sample size for you (for 3-way rep) if you have the CV, pt estimate, no?


Not quite. PowerTOST performs ‘classical’ sample size estimation, which is only part of the game:
  • GMR-restriction [0.80–1.25] not accounted for.
  • Scaling cap at 50 CV% (EMA) not accounted for.
  • Possibility of not being allowed to scale (CV in the actual study <30%) not accounted for.
For a summary see this post.

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