Ayman Rabayah
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Jordan,
2020-08-11 08:44
(43 d 19:54 ago)

Posting: # 21854
Views: 506
 

 Favipiravir Bioanalysis [Regulatives / Guidelines]

Hellow colleagues
Need your feedback about the Bio-analysis of Favipiravir, do the metabolite (Favipiravir RTP) need to be measured or only the Favipiravir, since no FDA or EMEA related guidance issued till date.
Appreciate your thoughts.

Ayman Ahmad
Helmut
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Vienna, Austria,
2020-08-11 11:35
(43 d 17:04 ago)

@ Ayman Rabayah
Posting: # 21855
Views: 428
 

 Homework

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:
  • 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).
  • For the EMA:
    • 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?
  • If problems with the parent (pro-drug or not), provide hard data to justify measuring a metabolite (active or not; if ever possible the first in the chain). If in doubt, consider a scientific advice (at a “difficult” member state). Assess BE based on the metabolite and report the parent descriptively (no CI).


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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Ayman Rabayah
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Jordan,
2020-08-12 07:56
(42 d 20:42 ago)

@ Helmut
Posting: # 21861
Views: 389
 

 Homework

» 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.

Thanks Helmut
I'm fine and hope to be in good health and conditions. How do you know "Shlonak" which is traditional local term in Jordan and some countries in the meddle east? I'm surprised that you know this term.
Thanks for the answer and directions, hope we will do the correct decision.

All the best.
Ayman
Helmut
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Vienna, Austria,
2020-08-12 12:57
(42 d 15:41 ago)

@ Ayman Rabayah
Posting: # 21863
Views: 373
 

 “Shlonak”

Salam Ayman,

» How do you know "Shlonak" which is traditional local term in Jordan and some countries in the meddle east? I'm surprised that you know this term.

I love Jordan and its people.
My first visit was in 1979 backpacking. :-D Last one in 2018 with a private Bedouin guide.

» Thanks for the answer and directions, …

You are welcome.

» … hope we will do the correct decision.

I’m sure you will. If you have doubts and specific questions feel free to ask.

Dif-tor heh smusma 🖖
Helmut Schütz
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