An alternate dumb answer [Bioanalytics]

posted by Ohlbe – France, 2024-08-12 23:37 (92 d 12:10 ago) – Posting: # 24152
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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

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