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RegisterSignificant difference in Cmax of Reference drug product [Study Assessment]
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?
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?
Complete thread:
- Significant difference in Cmax of Reference drug productMehul Patel 2021-08-17 10:00 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Significant difference in Cmax of Reference drug product Helmut 2021-08-17 11:57
- Significant difference in Cmax of Reference drug product Mehul Patel 2021-08-17 12:02
- Different products → different BA Helmut 2021-08-17 15:36
- Significant difference in Cmax of Reference drug product dshah 2021-08-21 10:48
- Significant difference in Cmax of Reference drug product Mehul Patel 2021-08-17 12:02
- Significant difference in Cmax of Reference drug product Helmut 2021-08-17 11:57
Ing. Helmut Schütz