Handbook on non-clinical safety testing.
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Date
2002
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
UNICEF/UNDP/World Bank/WHO
Abstract
This Handbook on Non-clinical Safety Testing is designed to serve as an aid for
scientists who wish to undertake non-clinical safety testing for regulatory purposes
during product development. It has been developed as part of a significant and wide-
ranging technology transfer and capacity building programme in the area of pre-clin-
ical product development for disease endemic countries.
The Non-clinical Safety Testing Handbook was produced by a Scientific Working
Group (SWG) on pre-clinical issues, convened by the UNICEF/UNDP/World Bank/WHO
Special Programme for Research & Training in Tropical Diseases (TDR) and consisting
of independent scientific specialists from around the world. The Handbook is broadly
based on current safety testing guidelines including those of the Organisation for Eco-
nomic Cooperation and Development (OECD) and the International Conference on
Harmonisation (ICH).
The Handbook will provide scientists and laboratories in disease endemic countries
with the necessary technical aid for planning and implementing non-clinical safety
testing programmes. The Handbook attempts to highlight the differences between syn-
thetic chemical drug, vaccine and traditional herbal (botanical) medicine development
programmes.
TDR gratefully acknowledges the participation and support of all those involved in
the production of this Handbook.
Description
Keywords
Handbook, Non clinical, Safety testing
Citation
Gamaniel,K.S,Gundiza,G., Matsabisa ,G.,Murilla,G.,Moshi,M.J.,Orwa J.,Rasoanaivo,P.,Seier,J.,Titanji,.V.,Walubo,A.,Yole,D.(2002)Handbook on non-clinical safety testing. Johannesburg.UNICEF/UNDP/World Bank/WHO.