median Tmax [Regulatives / Guidelines]

posted by santoshgadekar – 2009-02-07 09:10 (6352 d 20:13 ago) – Posting: # 3196
Views: 3,791

Dear all,
  1. What is Median Tmax?
  2. If a drug is having the Tmax of 1.5 hrs. The dosing of which was done at 8 o'clock in a Bioavalability study and a subject had vomiting after 3 hours post dose. so what will be the withdrawal criteria as the FDA guidelines says that the data should be deleted if vomiting occurs before 2 times median Tmax?

Thanks.

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