Clozapine bioequivalence
Executive Summary
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)...
You may also be interested in...
Clozapine guidance finalized
Bioequivalence studies for generic clozapine (Novartis' Clozaril) should only be conducted with patients who are already "stable" on clozapine dose, FDA's final guidance says. Initial version updated 1996 guidance to say clozapine bioequivalence should not be tested in healthy subjects (1"The Pink Sheet" Jan. 5, 2004, In Brief)...
In Brief: Clozapine bioequivalence
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)...
Cosmetic And Personal Care Trademark Review: 9 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.