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)...
You may also be interested in...
Clozapine bioequivalence
Bioequivalence studies for generic clozapine (Novartis' Clozaril) products should not be conducted using healthy subjects due to potential for hypotensive effects, FDA says in 1draft guidance posted Dec. 29. Agency also recommends multiple-dose BE studies using the highest dosages instead of a 12.5 mg dose. The document revises a November 1996 guidance (2"The Pink Sheet" Nov. 26, 1996, T&G-14)...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011