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Study material made available for the study of ICH Guidelines. ICH is the short form of 'International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Useq (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. The objective of ICH is to increase international harmonization of technical requirements to ensure that safe, effective, and high quality medicines are developed. and registered in the most efficient and cost effective manner. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.Study Material for ICH Guidelines Mr. Kishor Nagargoje ... need to carry out carcinogenicity studies in both mice and rats, and guidance is also given on alternative testing procedures which may be applied without jeopardizing safety. S1C(R2)anbsp;...

Author:Mr. Kishor Nagargoje
Publisher:Kishor Nagargoje - 2014-08-06


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