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

posted by Mehul Patel – India, 2021-08-17 10:00 (312 d 18:58 ago) – Posting: # 22520
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Hi,

Can anybody please tell what may be the probable reasons behind significant (more than 20%) difference in mean Cmax concentration of Reference product of a same batch number in two different studies conducted at same CRO and on the similar kind of population but different sample size?

Is it correct to compare and expect Reference product's behavior same for all repeated studies?

Moreover, Can 6 months old (frozen) samples yield significant different results as compared to freshly analyzed study samples?

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