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Ohlbe ★★★ France, 2022-06-10 12:48 (1470 d 10:39 ago) Posting: # 23049 Views: 6,590 |
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Dear all, The ICH M10 guideline "Bioanalytical method validation and study sample analysis" has been adopted on 24 May 2022 and published on the ICH web site. — Regards Ohlbe |
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qualityassurance ★ 2022-06-12 14:31 (1468 d 08:57 ago) @ Ohlbe Posting: # 23052 Views: 5,401 |
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❝ The ICH M10 guideline "Bioanalytical method validation and study sample analysis" has been adopted on 24 May 2022 and published on the ICH web site. Thank you Mr. Ohlbe for the update. Dear Members, The ICH guidelines asks for 100% of chromatograms to be submitted. As per EMA and USFDA requirements Chromatograms from 20% of subjects are required. Should we start submitting 100% chromatograms now. Regards |
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Ohlbe ★★★ France, 2022-06-14 13:37 (1466 d 09:50 ago) @ qualityassurance Posting: # 23056 Views: 5,331 |
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Dear Qualityassurance, ❝ The ICH guidelines asks for 100% of chromatograms to be submitted. As per EMA and USFDA requirements Chromatograms from 20% of subjects are required. ❝ ❝ Should we start submitting 100% chromatograms now. It will take a few more months before the guideline comes into force, but it will be applicable to any application submitted after a certain date, even if the trial was done earlier. I would suggest to start getting prepared and to start providing the sponsors with 100% chromatograms. — Regards Ohlbe |
Ing. Helmut Schütz