In Brief: Clozapine bioequivalence
Executive Summary
Clozapine bioequivalence: Guidance on in vivo bioequivalence and in vitro dissolution testing of clozapine (Sandoz' Clozaril) available from FDA. The guidance requires that I.V. access be provided for six hours after dosing in case of adverse effects in study subjects ("The Pink Sheet" May 6, T&G-4)...