Significant difference in Cmax of Reference drug product [Study As­sess­ment]

posted by Mehul Patel – India, 2021-08-17 14:02 (466 d 21:19 ago) – Posting: # 22522
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❝ I guess you had also the same batch of the test? Was the AUC different as well?

Both the tests were different but Reference were same. AUC of Reference was similar for both the studies, only Cmax varied by 22%. What may be the reasons for this?

❝ ❝ […] Can 6 months old (frozen) samples yield significant different results as compared to freshly analyzed study samples?

❝ If long term storage was validated for this duration, no.

Ok. Thanks

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 #5[Helmut]

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