Log in
RegisterReplicate Pilot study [Power / Sample Size]
Hi again Kumar Naidu,
Difficult. I would at least try to read up on Drugs@FDA and see if there have been some formulation changes since the 1992 approval. But trouble is, the immediately available reviews generally do not date all the way back to that time, if I recall correctly. So you may be a little in the dark. Paper-based FoI might be an option, I can't tell.
Sometimes yes. But depends on the type of formulation and on excipients. Regulators would probably say it depends somehow on proportionality of the formulations as well.
❝ 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.
Difficult. I would at least try to read up on Drugs@FDA and see if there have been some formulation changes since the 1992 approval. But trouble is, the immediately available reviews generally do not date all the way back to that time, if I recall correctly. So you may be a little in the dark. Paper-based FoI might be an option, I can't tell.
❝ Also can we correlate PK parameters of Drug A 250mgx2 with Drug A 500mgx1 if the drug is non-linear.
Sometimes yes. But depends on the type of formulation and on excipients. Regulators would probably say it depends somehow on proportionality of the formulations as well.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- sample size for partial replicate - USFDA niraj.bhatt 2013-10-17 08:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- N=24 or N=27 d_labes 2013-10-18 14:34
- Table A3 Helmut 2013-10-18 13:51
- sample size for partial replicate - USFDA niraj.bhatt 2013-10-18 08:18
- 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 studyElMaestro 2014-04-11 13:23
- Replicate Pilot study kumarnaidu 2014-04-14 06:22
- Replicate Pilot studyElMaestro 2014-04-11 13:23
- Replicate Pilot study kumarnaidu 2014-04-11 12:45
- Replicate Pilot study ElMaestro 2014-04-11 10:27
- forget the partial replicate niraj.bhatt 2013-10-18 07:57
- sample size for partial replicate - USFDA jag009 2013-10-17 15:09
Ing. Helmut Schütz