Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Open this folder and view contentsStability of drug dosage forms1
Open this folder and view contentsGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
Close this folderMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
View the documentIntroduction
View the documentGlossary
Open this folder and view contentsPart One. Regulatory assessment of interchangeable multisource pharmaceutical products
Open this folder and view contentsPart Two. Equivalence studies needed for marketing authorization
Open this folder and view contentsPart Three. Tests for equivalence
View the documentPart Four. In vitro dissolution tests in product development and quality control
View the documentPart Five. Clinically important variations in bioavailability leading to non-approval of the product
View the documentPart Six. Studies needed to support new post-marketing manufacturing conditions
View the documentPart Seven. Choice of reference product
View the documentAuthors
View the documentReferences
View the documentAppendix 1. Examples of national requirements for in vivo equivalence studies for drugs included in the WHO Model List of Essential Drugs (Canada, Germany and the USA, December 1994)
View the documentAppendix 2. Explanation of symbols used in the design of bioequivalence studies in humans, and commonly used pharmacokinetic abbreviations
View the documentAppendix 3. Technical aspects of bioequivalence statistics
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

Authors

The guidelines were developed during three meetings convened by the Division of Drug Management and Policies. World Health Organization, Geneva, Switzerland, on 18 - 19 February 1993, 23-27 August 1993, and 23-26 August 1994, attended by the following people:

Professor J.-M. Aiache, University of Clermont-Ferrand, Clermont-Ferrand, France

Dr Andayaningsih, Ministry of Health, Jakarta, Indonesia

Dr N. Aoyagi, National Institute of Health Sciences, Tokyo, Japan

Dr E. Beyssac, University of Clermont-Ferrand, Clermont-Ferrand, France

Professor D. Birkett, Flinders Medical Centre, Bedford Park, Australia

Dr D. Blois, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva, Switzerland

Professor H. Blume, International Pharmaceutical Federation (FIP), Eschborn, Germany

Professor A. Bondani, General Directorate for the Control of Health Inputs, Mexico City, Mexico

Miss M. Cone, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva, Switzerland

Mr M. N. Dauramanzi, Drugs Control Council, Harare, Zimbabwe

Mr T. Fushimi, Ministry of Health and Welfare, Tokyo, Japan

Professor U. Gundert-Remy (Chairman), Department of Clinical Pharmacology, University of Göttingen, Göttingen, Germany

Dr C. G. Guyer, Food and Drug Administration, Rockville, MD, USA

Professor F. D. Juma, University of Nairobi, Nairobi, Kenya

Professor G. Kreutz, Federal Institute for Drugs and Medicinal Devices, Berlin, Germany

Dr L. Lacy, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva, Switzerland

Dr I. J. McGilveray, Drugs Directorate, Ottawa, Canada

Dr O. Morin, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva, Switzerland

Dr R. Nedich, Generic Pharmaceutical Industry Association, Washington, DC, USA

Dr A. Nijkerk, European Generic Medicines Association, Brussels, Belgium

Dr H. P. Osterwald, European Generic Medicines Association, Brussels, Belgium

Professor T. L. Paál, National Institute of Pharmacy, Budapest, Hungary

Dr R. N. Patnaik, Food and Drug Administration, Rockville, MD, USA

Dr J. M. Peón, General Directorate for the Control of Health Inputs. Mexico City, Mexico

Miss M.-C. Pickaert, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva, Switzerland

Professor L. Rägo, State Agency of Medicines, Tartu, Estonia

Dr B. Rosenkranz, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Geneva, Switzerland

Dr H. Scheinin, Turku University Central Hospital, Turku, Finland

Mr N. Uemura, Ministry of Health, Tokyo, Japan

Professor B. Vrhovac, University Hospital Medical School, Zagreb, Croatia

Dr R. L. Williams, Food and Drug Administration, Rockville, MD, USA

Secretariat (WHO, Geneva, Switzerland)

Dr J. F. Dunne, Director, Division of Drug Management and Policies

Dr J. Idänpään-Heikkilä, Associate Director, Division of Drug Management and Policies

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