Non Linearity (SD vs. MD) [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2010-08-13 21:11 (5778 d 23:34 ago) – Posting: # 5785
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Dear ElMestro & Cmax (interesting nick)!

❝ To investigate linearity several dose levels need to be investigated.


... and the design depends on how much previous information about the drug one has. Single dose studies generally suffice for most drugs, but for new drugs (i.e., full characterisation of pharmacokinetics) one has to opt for steady state. Otherwise time-dependent effects (e.g., enzyme-induction or -inhibition) may not be detected.

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