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auditor ★ India, 2012-02-01 13:58 (4466 d 10:00 ago) Posting: # 8036 Views: 3,937 |
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Dear All, Kindly advice what to do with following cases in one of the prazole group. This is going to be submitted in US FDA.
regards, Auditor Edit: Category changed. [Helmut] |
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ElMaestro ★★★ Denmark, 2012-02-02 13:05 (4465 d 10:53 ago) @ auditor Posting: # 8039 Views: 3,201 |
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Hi auditor, ❝ 1. 13 out of 52 PK profiles are having 2 or less measurable concentrations for the test treatment. ❝ 2. 25 out of 104 PK profiles are having 2 or less measurable concentrations for the reference treatment. ❝ 3. 23 out of 52 PK profiles are having first measurable point as Cmax (not first point Cmax) for the test product. ❝ 4. 46 out of 104 PK profiles are having first measurable point as Cmax for the reference product. Sounds like something went badly wrong a lot of times. And you lost a lot of statistical power because of it. ❝ Let me clear you that the study is passing but we are worried about above mentioned case. kindly advice how to handle this and how the regulatory take this. Passing? What does the term mean in this context? Being submitted or even being accepted? I would focus very hard now on making sure you can demonstrate that you have treated the surprising result in a fair and objective fashion. You have a cause for auditing here, I would say (GCP, GLP possibly GMP). Your goal would be to determine a root cause for this surprise or at least try to, and along those lines to find out if any violation of the standards was involved and how such issues can be avoided again. It might in the US be considered unethical to conduct studies until you have proven by root cause analysis this won't happen again as carrying on could imply simple putting trial subjects into futile testing. Not sure if EU inspectors at present would be equally strict?  A million things could have been compromised, but there might not be any identifiable issue other than the result itself. Did you do re-analysis of any samples*? Best regards, EM, who just had a nice root course. *: I do not mean reanalysis in the I-want-to-repeat-sample-analysis-until-my-result-is-right-kind-of-way, but rather in the I-want-to-reanalyse-to-e.g.-prioritise-if-I-should-do-GCP-audit-before-GLP-audit-kind-of-way. |
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Ohlbe ★★★ France, 2012-02-02 20:13 (4465 d 03:45 ago) @ auditor Posting: # 8040 Views: 3,085 |
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Dear Auditor, Is this a fed study ? Prazoles sometimes have a very strange behaviour in these studies (you'll find some discussions if you search the forum). Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz