Log in
Register|
AUClast ☆ 2012-11-08 19:46 (4981 d 12:57 ago) Posting: # 9526 Views: 4,871 |
|
|
What are the current retention requirements for the comparator product drug? Should the sponsor maintain samples? thank you — AUClast |
|
drgunasakaran1 ★★  2012-11-09 03:31 (4981 d 05:12 ago) @ AUClast Posting: # 9527 Views: 4,437 |
|
|
❝ What are the current retention requirements for the comparator product drug? Dear Mr AUClast, Kindly follow the forum policy, see here The retention requirements varies based on the country of submission. Let us know, which country of submission you are talking about.? For US Retention sample requirements, see here For EMA Retention sample requirements, see here — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
|
AUClast ☆ 2012-11-09 12:24 (4980 d 20:18 ago) @ drgunasakaran1 Posting: # 9528 Views: 4,429 |
|
|
Dear Gunasakaran Thank you. Actually the question is general. Thank you for the links, actually I was missing the proper section of Annex 13. Kind regards Dear Gunasakaran Sorry, puzzled again. I understand the requirements for the product in test (either reference or retention) but if I use in a trial a comparator product from the market not modified (eg. not repacked), is this included in the definition or not? thank you Edit: Merged a later post. No need to open a new one. [Helmut] — AUClast |
Ing. Helmut Schütz