Bioequivalence and Bioavailability Forum • sample size for partial replicate

sample size for partial replicate - USFDA [Power / Sample Size]

posted by niraj.bhatt – India, 2013-10-18 10:18 (4628 d 16:04 ago) – Posting: # 11688
Views: 17,289

Dear John,

Thank you for your reply.

I have found a paper "Tothfalusi & Endrenyi. Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs. J Pharm Pharmaceut Sci. 15(1) 73-84, 2012".

Suppose within-subject variability for reference formulation in 3 -period partial replicate study was found 30%.

Then as per above paper, sample size for 3 -period partial replicate pivotal study, intended for USFDA submission, is 24 subjects for GMR of 0.95 to acheive at least 80% power for within-subject variability of reference formulation of 30% (as per page 11 of 12 from above paper).

I am looking forward your suggestion for my understanding.

Best regards.
Niraj

Complete thread:

sample size for partial replicate - USFDA niraj.bhatt 2013-10-17 08:53 [Power / Sample Size]
- sample size for partial replicate - USFDA jag009 2013-10-17 15:09
  - sample size for partial replicate - USFDAniraj.bhatt 2013-10-18 08:18
    - Table A3 Helmut 2013-10-18 13:51
      - N=24 or N=27 d_labes 2013-10-18 14:34
        
        in praise of 100,000 sim’s Helmut 2013-10-18 15:02
        N=24 or N=27 niraj.bhatt 2013-10-19 06:19
      - Table A3 niraj.bhatt 2013-10-19 06:18
- forget the partial replicate Helmut 2013-10-18 00:14
  - forget the partial replicate niraj.bhatt 2013-10-18 07:57
    - PowerTOST and RSABE d_labes 2013-10-18 11:16
  - Replicate Pilot study kumarnaidu 2014-04-11 07:37
    - Replicate Pilot study ElMaestro 2014-04-11 10:27
      - Replicate Pilot study kumarnaidu 2014-04-11 12:45
        
        Replicate Pilot study ElMaestro 2014-04-11 13:23
        
        Replicate Pilot study kumarnaidu 2014-04-14 06:22