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World Health Organization : Technical Report Series, No. 341: Principles for Pre-Clinical Testing of Drug Safety

By J. J. Burns

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Book Id: WPLBN0000114857
Format Type: PDF eBook
File Size: 1.1 MB
Reproduction Date: 2005

Title: World Health Organization : Technical Report Series, No. 341: Principles for Pre-Clinical Testing of Drug Safety  
Author: J. J. Burns
Volume:
Language: English
Subject: Health., Public health, Wellness programs
Collections: Medical Library Collection, World Health Collection
Historic
Publication Date:
Publisher: World Health Organization

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Burns, J. J. (n.d.). World Health Organization : Technical Report Series, No. 341. Retrieved from http://cn.ebooklibrary.org/


Description
Medical Reference Publication

Excerpt
1. INTRODUCTION The governing bodies of WHO and its Advisory Committee on Medical Research, assisted by advisory scientific groups, have explored ways and means by which WHO can contribute to the promotion of the therapeutic safety of drugs. As a result, the World Health Assembly decided, inter alia, that generally acceptable principles and requirements for the evaluation of the safety and efficacy of drugs should be formulated under the authority of WHO. The WHO Symposium on the Toxicology of Drugs: considering it inadvisable to establish and prescribe rigidly formulated regulations specifying in detail the tests to be performed, recommended that guidelines for the toxicological and pharmacological evaluation of safety and efficacy should be developed under scientific authority. Agreement on the basic principles governing the testing of drugs for therapeutic safety would, indeed, appear to be all that is possible and desirable at this juncture ; requirements, with their inherent tendency to be specific, detailed, and conducive to rigid application, would have little chance of being generally accepted.

Table of Contents
CONTENTS 1. Introduction . . . . . . . . . . . . . . . . . . . . . 3 2. General considerations . . . . . . . . . . . . . . . . 4 3. Biochemical studies . . . . . . . . . . . . . . . . . . 7 4. Pharmacological and toxicological studies . . . . . . . . 1 1 5. Relationship between animal and human studies. . . . . 18 6. Concluding remarks. . . . . . . . . . . . . . . . . . 20

 
 



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