Bioequivalence and Bioavailability Forum

Can of worms [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-02-03 21:28 (1773 d 18:28 ago) – Posting: # 21134
Views: 4,948

Hi ElMastro,

❝ Try and discuss the case with different CROs, I think you find that several of them (in EU their numbers are limited) have been in situation before and have been discussing the matter with other sponsors + authorities as well as with IECs.

Well my predecessor ran the IR SS study (over the total daily dose) many years ago and she ran it in UK. Not sure if she explored many European countries. She didn't do in US due to need for IND.

❝ What are you actually going to measure?

You mean what fluid? Blood and Urine sampling. Will measure parent and metabolites, and something new (some sort of marker) if the analytical method of interest is available (to be confirmed)

Thx
J

Complete thread:

• EMA: What do I need if I want to run an overdose study jag009 2020-01-28 20:12 [Regulatives / Guidelines] 
  • EMA: What do I need if I want to run an overdose study Helmut 2020-01-29 16:52
    • EMA: What do I need if I want to run an overdose study jag009 2020-01-30 04:32
      • Can of worms Helmut 2020-01-30 13:32
        • Can of worms ElMaestro 2020-01-30 15:12
          • Can of wormsjag009 2020-02-03 20:28
        • Can of worms jag009 2020-02-03 20:34
  • EMA: What do I need if I want to run an overdose study Ohlbe 2020-01-30 17:32
    • EMA: What do I need if I want to run an overdose study jag009 2020-02-03 20:23