Deconvolution sample size and exponential terms [Power / Sample Size]

posted by dshah  – India/United Kingdom, 2023-02-10 10:34 (381 d 08:10 ago) – Posting: # 23453
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Dear Mittyri!

❝ As for other studies, just CV is not enough. What are the regulatory limits then and for what metric? That phrase in MR GL seems like just exploratory analysis with descriptive statistic, since there are no predictions and no checking against set of MR formulations as we do in IVIVC


Is the aim here to develop an IVIVC or develop a new MR formulation of drug that is already authorized in a formulation with a different release rate? I believe we are focusing on (dosing regiment)IR vs MR. So at least CV for AUC depending on matrix would be taken into consideration.

❝ Does it mean that exponential terms should be derived from individual models of subjects after dosing by IR product?


It means that same model needs to be applied to all individual to derive individual exponential terms to evaluated individual deconvoluted profile.

Regards,
Divyen

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