世界卫生组织发布的BCS分类(2005年).pdf

Working document QAS/04.109/Rev.1 page 1 WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTE PROPOSAL TO WAIVE IN VIVO BIOEQUIVALENCE REQUIREMENTS FOR THE WHO MODEL LIST OF ESSENTIAL MEDICINES IMMEDIATE RELEASE, SOLID ORAL DOSAGE FORMS This document has been revised by Professor Jennifer B. Dressman, Institut für Pharmazeutische Technologie, Biozentrum, Johann Wolfgang Goethe-Universität, Frankfurt/Main, Germany. It has followed the steps given in the schedule on page 2 herein. It has been very widely distributed and numerous comments have been incorporated. Please address any comments and/or corrections you may have to Dr S. Kopp, Quality Assurance and Safety: Medicines, Medicines Policy and Standards, World Health Organization, 1211 Geneva 27, Switzerland, fax: (+41 22) 791 4730 or e-mail: kopps@ (with a copy to bonnyw@) by 20 October 2005. © World Health Organization 2005 All rights reserved. This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations’ concerned staff and member organizations) without the permission of WHO. The draft should not be displayed on any website. Please send any request for permission to: Dr Sabine Kopp, Quality Assurance Safety: Medicines (QSM), Department of Medicines Policy and Standards (PSM), World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730; e-mails: kopps@; bonnyw@ The designations employed and the presen