Bioequivalence and Bioavailability Forum • Replicate Pilot study

Replicate Pilot study [Power / Sample Size]

posted by kumarnaidu – Mumbai, India, 2014-04-11 14:45 (4455 d 14:02 ago) – Posting: # 12810
Views: 16,371

Thanks ElMaestro for your reply.
I want to know that how far it is right to correlate the values of the PK parameters mentioned in the literature for the RLD at the time of its approval (say approved in 1992) to the present day values of the RLD observed in the recent studies, especially when the drug is high variable.

Also can we correlate PK parameters of Drug A 250mgx2 with Drug A 500mgx1 if the drug is non-linear.

—
Kumar Naidu

Complete thread:

sample size for partial replicate - USFDA niraj.bhatt 2013-10-17 08:53
- sample size for partial replicate - USFDA jag009 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 studykumarnaidu 2014-04-11 12:45
        
        Replicate Pilot study ElMaestro 2014-04-11 13:23
        
        Replicate Pilot study kumarnaidu 2014-04-14 06:22