The Requirements of Chemical Manufacturing and Control in the Pre-clinical and Clinical Studies of a Potential Drug

Shilei Wang; Ying Chen; Shuo Liu; Min Li; Jiong Tang; Guohua Zhu; Lichun Sun

Abstract

The Requirements of Chemical Manufacturing and Control in the Pre-clinical and Clinical Studies of a Potential Drug

Drug research and development is time-consuming and huge expensive with a high risk and a low success. There is just a little chance to go through the entire process from discovery to clinical studies and eventually bring a drug into the commercial drug market. The chemical manufacturing and control (CMC) play a critical role in the new drug development and usually accompanies with the entire process from pre-clinical studies to clinical studies, even to commercially marketed drugs. The quality control of products, removal of impurity and the establishment of technological standards during CMC process of production and management can ensure the identity and qualification of the tested drugs and maximally guarantee solid and trustable clinical data which are so significant to evaluate a potential drug and enhance the little valuable chance of the drug to succeed.

Author(s):

Shilei Wang, Ying Chen, Shuo Liu, Min Li, Jiong Tang, Guohua Zhu and Lichun Sun

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