Bioequivalence and Bioavailability Forum • An alternate dumb answer

An alternate dumb answer [Bioanalytics]

posted by Ohlbe – France, 2024-08-12 23:37 (284 d 04:11 ago) – Posting: # 24152
Views: 2,861

Hi John,

Define free and total...

The draft FDA dabigatran product-specific guidance uses "free" to designate non-conjugated dabigatran and "total" for the sum of non-conjugated + conjugated dabigatran, measured after hydrolysis of the conjugates. I can live with "total", but "free" is a misnomer IMHO.

In this particular case you will get 2 bioanalytical reports, one for "free" and one for "total", which should be clearly identified.

—
Regards
Ohlbe

Complete thread:

A dumb question jag009 2024-08-12 13:17
- A dumb answer Helmut 2024-08-12 13:45
  - A dumb answer jag009 2024-08-12 14:35
    - A dumb answer Helmut 2024-08-12 15:01
      - A dumb answer ElMaestro 2024-08-12 15:13
        
        A dumb answer Helmut 2024-08-12 15:30
- An alternate dumb answerOhlbe 2024-08-12 21:37
  - An alternate dumb answer jag009 2024-08-13 06:27
  - Unconjugated ≠ free Helmut 2024-08-13 07:31
    - Unconjugated ≠ free jag009 2024-08-26 16:19
- A dumb question Achievwin 2024-08-27 03:02