Bioequivalence and Bioavailability Forum • sample size for partial replicate

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

posted by jag009 – NJ, 2013-10-17 17:09 (4632 d 19:12 ago) – Posting: # 11676
Views: 17,401

Hi,

Use PowerTOST from R or you can get the sample size from a paper:

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

John

Complete thread:

sample size for partial replicate - USFDA niraj.bhatt 2013-10-17 08:53
- sample size for partial replicate - USFDAjag009 2013-10-17 15:09
  - sample size for partial replicate - USFDA niraj.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