Homework [Regulatives / Guidelines]
❝ […] 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:
- Is is a pro-drug?
- Are you able to measure the parent at the intended dose with sufficient accuracy & precision (LLOQ ≤5% Cmax in any of the subjects)? Obtain information about the between-subject variability to get an idea what to expect in the worst case.
- For the FDA:
- AUC0–72 acceptable as an alternative to AUC0–t & AUC0–∞ (but not for HVD(P)s).
- LLOQ sufficient to get a reliable estimate of AUC (AUC0–t ≥80% AUC0–∞) with the intended sampling schedule?
If IR, AUC0–72 (without extrapolation) is an alternative.
If MR, AUC0–t & AUC0–∞ mandatory.
- If at the highest strength difficult, is it possible (safety!) to administer a higher dose?
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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