Sampling Time points and Sample Size [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-02-23 19:06 (2310 d 05:46 ago) – Posting: # 18451
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Why do you need to calculate sampling time points? You need to draft your sampling time points based on half-life of the drug and the drug in-vivo release profile. If it's a generic product then you draft your time points based on the brand's profile. If it's a NDA then you draft your time points based on your expected drug release profile.


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