in vivo ≠ in vitro [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2022-07-25 11:56 (582 d 05:03 ago) – Posting: # 23167
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Hi Mithu,

❝ Is it advisable to have little large sample size …


Larger than what?

❝ … for molecules falls under BCS Class II and IV? especially when routine 2WC design is selected?


Only in a few cases of BCS class II drugs (under certain conditions) there is an in vivo in vitro correlation. For BCS class IV drugs never. You plan the study always based on the in vivo variability and T/R-ratio for a desired power. In other words, BCS does not play any role.

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