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scorp2011 ☆ India, 2014-03-18 08:35 (4482 d 18:14 ago) Posting: # 12644 Views: 3,513 |
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Dear Team, Please guide me: Study 1 of XYZ product conducted at CRO 1. Now we are planning to conduct Study 2 of same XYZ product at a different CRO 2. Please suggest the requirement for retention of investigational products to be retained. Do we need to retain samples required for 5-times release test at each CRO (say for example 300 samples at CRO 1 and 300 samples at CRO 2) or else will a total of 300 samples combined at both the CRO's will suffice (say for example 200 at CRO 1 and 100 at CRO 2). Regards Sonu |
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Dr_Dan ★★ Germany, 2014-03-18 12:52 (4482 d 13:57 ago) @ scorp2011 Posting: # 12650 Views: 2,987 |
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Dear Sonu I guess the studies are to be conducted according to FDA regulation for an ANDA application, right? In this case where a CRO with multiple testing facilities conducts more than one BE study (e.g., fed and fasted studies) for the same drug product, and the study test article and reference standard are sent to the testing facilities in different shipments, the FDA recommends that sufficient quantity of reserve samples be kept for each study at each testing facility. These approaches are to ensure that the reserve samples are in fact representative of the batch provided by the study sponsor and/or drug manufacturer to the testing facility. I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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scorp2011 ☆ India, 2014-03-19 13:30 (4481 d 13:19 ago) (edited on 2014-03-19 14:07) @ Dr_Dan Posting: # 12669 Views: 2,960 |
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Dear Dr. Dan Thanks for the clarification. Yes, these studies are to be conducted according to FDA regulations for an ANDA application. Please note that these two studies (fasting and fed) are to be conducted at two different CRO's. The CRO's are not linked to each other. One is located in India and other is located in US. kindly let me know of your expert opinion over this particular scenario for retention of IP's. Thanks once again. Regards Sonu 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] |
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Ohlbe ★★★ France, 2014-03-19 15:12 (4481 d 11:37 ago) @ scorp2011 Posting: # 12671 Views: 2,974 |
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Dear Sonu, I think the rule is clear: you have to keep the required amount of test articles at each CRO. Remember that the idea behind that requirement is not just to check that the IP pass the release tests. The idea is also to be able to check the identity of the products used and to make it more difficult to run the BE as reference vs. reference by labelling some reference IP as test, as found in the generic drug scandal in the USA in the early '80s. Therefore retention IPs need to be kept at each trial site. — Regards Ohlbe |
Ing. Helmut Schütz