Evaluation of Reference variability [Design Issues]
❝ Same opinions were expressed at the EUFEPS meeting last January (see this thread), where almost the entire PK group of EMEAas present. The group univocally expressed their point of view that a two period replicate design (reference only) is not acceptable.
Hello all. My apologies for dragging this replicate skeleton out of the closet when it seemed like it was comfortably resting.
Was there any mention at this meeting as to whether the results of a replicate design study (finding of intra-subject variablility exceeding 30%) with a lower strength can be used to justify widen acceptance limits for a higher strength of the same drug to undergo a standard BE study?
If this is not allowed, can someone explain why not?
Thank you in advance.
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! [Jaime]
Complete thread:
- Evaluation of Reference variability Nirali 2009-04-13 11:53 [Design Issues]
- Evaluation of Reference variability KR 2009-04-13 14:39
- Evaluation of Reference variability Ravi 2009-04-14 06:25
- Evaluation of Reference variability Nirali 2009-04-17 07:38
- Evaluation of Reference variability Ohlbe 2009-04-17 10:04
- Evaluation of Reference variability Helmut 2009-04-17 13:44
- Evaluation of Reference variability Nirali 2009-04-18 09:04
- Evaluation of Reference variability Helmut 2009-04-18 12:31
- Evaluation of Reference variability Nirali 2009-04-18 19:34
- Evaluation of Reference variability Helmut 2009-04-18 12:31
- Evaluation of Reference variabilityMarcel 2010-03-16 13:10
- Evaluation of Reference variability Helmut 2010-03-16 16:01
- Evaluation of Reference variability ElMaestro 2010-03-16 17:13
- Some desultory thoughts Helmut 2010-03-16 18:59
- Evaluation of Reference variability Marcel 2010-03-17 12:47
- Evaluation of Reference variability ElMaestro 2010-03-16 17:13
- Evaluation of Reference variability Helmut 2010-03-16 16:01
- Evaluation of Reference variability Nirali 2009-04-18 09:04
- Evaluation of Reference variability Nirali 2009-04-17 07:38