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 wideranging technology transfer and capacity building programme
in the area of pre-clinical 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 Economic 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 synthetic
chemical drug, vaccine and traditional herbal (botanical) medicine development