Homework [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-08-11 09:35 (77 d 07:44 ago) – Posting: # 21855
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Shlonak Ayman,

» […] do the metabolite (Favipiravir RTP) need to be measured or only the Favipiravir, since no FDA or EMEA related guidance issued till date.

Parent is always preferred, even if a pro-drug (FDA Section V.A.1., EMA Section 4.1.5). You have to know which dose(s) will be administered (FDA Section VI.B.1., EMA Section the 4.1.6). Please consult the relevant guidelines (FDA, EMA IR, MR) with answers to these questions at hand:

P.S.: The EMEA (European Agency for the Evaluation of Medicinal Products) was renamed to EMA (European Medicines Agency) back in 2005. ;-)

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