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Rajdeep ★ New Delhi, India, 2010-10-19 14:25 (5316 d 16:10 ago) Posting: # 6062 Views: 6,913 |
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Dear All Need your feedback on the regulatory aspect. What if the sponsor fails to provide the information about the in-vitro release test data for calculating retention quantity for USFDA BE studies and also fails to provide the upper limit of [300 units (test/reference each)] solid dosage-formulation? Can a CRO retain the balance samples as suggested by the sponsor? What if the CRO has raised the concern but the sponsor instructs to retain the balance IPs. Is the step okay? Which body (CRO/sponsor)will be responsible for the same? And what will be the regulatory concern?  Edit: Category changed. [Helmut] — Best regards Rajdeep Mukherjee Protocol Developer |
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kapil pandya ☆ 2010-11-12 13:38 (5292 d 15:58 ago) @ Rajdeep Posting: # 6141 Views: 5,689 |
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The sponsor may not reveal the quantity of in-vitro tests for the sake of confidentiality, but they may provide a statement that the remaining quantity of IP is sufficient for retention as per USFDA guideline. 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! [Ohlbe] |
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Dr_Dan ★★ Germany, 2010-11-16 12:35 (5288 d 17:01 ago) @ Rajdeep Posting: # 6150 Views: 5,623 |
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Dear Rajeep, If you perform a confirmatory BE study you have to take samples from a production scale batch. So the sponsor should be able to provide enough retention samples. If the sponsor did not provide enough samples he has to take the consequences..... If the sponsor fails to provide information about the in-vitro release test data you should be alerted. Does the sponsor intent to test quick and dirty a formulation without having any data? What about CoA? How do you get a positive ethics vote and/or approval from your competent regulatory authority? The retention samples have to be stored under the same conditions as the study medication at the CRO. For an exploratory pilot study you do not have to store retention samples (I guell this is the case, right?) I hope this helps Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz