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

posted by jag009  – NJ, 2012-03-29 19:34  – Posting: # 8349
Views: 7,924

Hi everyone,

Regarding the FDA guidance on pre-dose concentration:

"If the predose concentration is less than or equal to 5 percent of Cmax value in that subject, the subjects data without any adjustments can be included in all pharmacokinetic measurements and calculations. If the predose value is greater than 5 percent of Cmax, the subject should be dropped from all BE study evaluations."

What if a subject has a pre-dose concentration in period 1? Should the subject still be kept or needs to be removed since he shouldn't have any pre-dose concentration in period 1.

Clinic shows no deviations and data was reviewed.



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