0 hr Pre-dose concentration but less than 5% of Cmax [Regulatives / Guidelines]

posted by jag009  – NJ, 2012-03-29 20:10 (3587 d 10:29 ago) – Posting: # 8351
Views: 8,563

Thanks Helmut

» Shit happens. But:
  • The guidance does not distinguish between period 1 and the others. Though you are right that pre-dose values in period 1 are less likely (carry-over due to too short wash-out are possible in higher ones).
  • If you have an SOP for pharmacokinetic repeats in place perform a reanalysis. Maybe the value will not be confirmed.
  • Remember the requirements for testing interferences in method validation: none out of six independent sources of matrix. If 0/6 is OK does that imply that 1/7 is OK as well? In other words even if your method was validated – in a large study you may see interferences. Keep the subject.

That's what I thought as well (Keeping the subject) since the guidance just stated the 5% rule but nothing about period 1 or period n.


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