- Keywords > drug development process
- Keywords > Good Laboratory Practice (GLP)
- Keywords > non-clinical safety testing
- Keywords > pre-clinical product
- Keywords > product development - preclinical phases of development
- Keywords > quality standards - non-clinical testing
- Keywords > research and development
- Keywords > safety
- Keywords > safety testing
- Keywords > toxicity studies
(2004; 125 pages)
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 programmes.