Log in
Register|
nlpati ☆ India, 2018-02-19 12:10 (2429 d 21:34 ago) Posting: # 18433 Views: 6,622 |
|
|
Dear Sir/ Madam, If we have conducted fed and fasting study in one site and the sponsor wants to continue the study with remaining IPs in another site with the same test and reference in which there is shortage of any of the IPs. For example if sufficient amount of test is not available in required quantity (for retention) for upcoming study. Can we proceed with new shipment of IPs provided by sponsor as second shipment (in which only 1 container will be provided for conduct of study) only for the conduct of study and considering the retention samples from first shipment. Kindly provide your opinion regarding this scenario. Also kindly opine whether this single container can be used for study or need to be retained as retention sample with out using for the study. Edit: Category changed; see also this post #1. [Helmut] |
|
Ohlbe ★★★ France, 2018-02-19 12:43 (2429 d 21:01 ago) @ nlpati Posting: # 18434 Views: 5,752 |
|
|
Dear nlpati, Is your study for USFDA submission ? If it is: is anything unclear in the FDA guidance, which you can find on the BEBAC guidance page ? — Regards Ohlbe |
|
nlpati ☆ India, 2018-02-22 09:06 (2427 d 00:39 ago) (edited on 2018-02-22 10:03) @ Ohlbe Posting: # 18444 Views: 5,482 |
|
|
Helmut ★★★   Vienna, Austria, 2018-02-19 13:44 (2429 d 20:01 ago) @ nlpati Posting: # 18435 Views: 5,797 |
|
|
Hi Nlpati, ❝ If we have conducted fed and fasting study in one site and the sponsor wants to continue the study with remaining IPs in another site with the same test and reference… I don’t understand. The study is completed and the sponsor wants to increase the sample size – because the study failed?
PS: Your e-mail address is not valid any more. Please either change it or uncheck the e-mail notification box in future posts. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
jag009 ★★★ NJ, 2018-02-21 21:24 (2427 d 12:20 ago) @ Helmut Posting: # 18440 Views: 5,566 |
|
|
Helmut! I think he meant to run new studies and wanted to transfer IPs from the completed studies etc etc... I think... John |
|
nlpati ☆ India, 2018-02-22 09:12 (2427 d 00:33 ago) (edited on 2018-02-22 10:02) @ Helmut Posting: # 18445 Views: 5,517 |
|
|
Hi Helmut, ❝ I don’t understand. The study is completed and the sponsor wants to increase the sample size – because the study failed? Study is completed and wants to do additional study with some additional subjects and planning to retrieve IPs from previous passed study. For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study. with regards, Lakshmipathy Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
|
Ohlbe ★★★ France, 2018-02-22 11:19 (2426 d 22:25 ago) @ nlpati Posting: # 18446 Views: 5,428 |
|
|
Dear Lakshmipathy, ❝ For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study. Then I will ask the same question again: what exactly do you not understand in section IV of the FDA guidance ? Did you read it carefully ? What is your opinion ? — Regards Ohlbe |
Ing. Helmut Schütz