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03/18/2014

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Guidance for Industry

Clozapine Tablets: In Vivo
Bioequivalence and In Vitro
Dissolution Testing

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

June 2005
BP
Revision I

Clozapine Tablets: In Vivo
Bioequivalence and In Vitro
Dissolution Testing

Additional copies are available from:

Office of Training and Communication
Division of Drug Information, HFD-240
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane

Rockville, MD 20857
(Tel) 301-827-4573
http://www.fda.gov/cder/guidance/index.htm

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

June 2005
BP
Revision 1
Guidance for Industry
TABLE OF CONTENTS

I. INTRODUCTION.................................................................................................................1 II. BACKGROUND...................................................................................................................1 III.

IN VIVO STUDIES........................................................................................................... 2

A. Product Information.........................................................................................................2 B. Steady-State Bioequivalence Study................................................................................. 3 C. Other Recommendations..................................................................................................6

IV.
IN VITRO TESTING CRITERIA.................................................................................. 7
A. Dissolution Testing............................................................................................................7
B. Content Uniformity Test.................................................................................................. 7
V. WAIVER REQUIREMENTS..............................................................................................7

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