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Brus ★ Spain, 2026-02-12 17:04 (112 d 05:59 ago) Posting: # 24571 Views: 1,516 |
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Hello, In terms off bioanalytical cross validation expectations. If we have several phase I studies in the dossier with different bioanalytical methods fully validated. And each individual study has single method and/or laboratory. And no pooled studies are performed, but of course all studies are the support of the dossier, should it be performed a cross validation of all studies following ICH M10 below section? Section 6.2:
Edit: Guideline section linked. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2026-02-13 10:47 (111 d 12:15 ago) @ Brus Posting: # 24572 Views: 1,226 |
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Hi Brus, the section continues with: If data are obtained from different fully validated methods, and these data are not to be combined across studies, cross validation is not generally required. In the area of BE, I was never asked for a cross-validation, since each study stands on each own. — 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 |
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Brus ★ Spain, 2026-02-25 14:20 (99 d 08:43 ago) @ Helmut Posting: # 24577 Views: 1,090 |
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❝ the section continues with: ❝ If data are obtained from different fully validated methods, and these data are not to be combined across studies, cross validation is not generally required. ❝ In the area of BE, I was never asked for a cross-validation, since each study stands on each own. Dear Helmut, Thank you so much for your response. I was referring for a new molecule (full dossier), in which you have several phase I from different CROs. Despite you used same method in all CRO (method transfer and full validation), since all studies will support the efficacy/safety of the dossier, would it be necessary a cross-validation? Or in the case of multiple BE study (for example prolonged realease: Fast, Fed, steady-state), if you use two different bioanalytical sites, do you need a cross-reference since "Data are obtained from different fully validated methods across studies that are going to be combined or compared to support..."? Or the word "combined" and "compared" is only applicabe if they are pooled? Best regards, |
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dshah ★★ India, 2026-02-27 12:12 (97 d 10:51 ago) @ Brus Posting: # 24580 Views: 1,065 |
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Hi Brus! Generally Helmut's remark is acceptable considering you are not drawing any conclusion from different BE studies. But as you are using it for new molecule, kindly consider below scenario. Scenario 1: A bridging study requiring BE for phase 1 formulation with TBM formulation in fasting condition, along with fed arm for TMB Scenario 2: Two separate study of phase 1 formulation vs TBM formulation in fasting condition and TBM fasting vs Fed condition. Though you may find BE for phase 1 and TBM formulation, the food effect needs to be consider for label. There is a possibility that as per scenario 2- the fasting levels in your (a) phase 1 formulation vs TMB and (b) Fasting TBM vs Fed TBM could be different. So why there is difference in both the separate study? Is it due to subject change or due to bioanalytical method? In such scenario, the cross validation can play a crucial role in drawing a conclusion of food effect. Divyen |
Ing. Helmut Schütz