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Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride This paper reflects the scientific opinion of the authors and not the policies of regulating agencies.
(Wiley Subscription Services, Inc., A Wiley Company, 2006-05)
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing amitriptyline hydrochloride are reviewed. ...