回复：哪个搞药的高人指点一下，什么是CMC ?

There are two big funtional groups in pharmaceutical R&D. The first is clinical and the other is non-clinical. Non-clinical or pre-clinical is doing safety testing of drug candidate before going to the human. That is where CMC coming from. You need drug candidate to go into pre-clinical, so you need to know how to manufacture your drug substance (API, active pharmaceutical ingredient) and then you need to make a drug product by formulating with excipients. All the manufacturing of the drug supply is part of CMC. Another words, the CMC cover raw material control, drug substance and drug product manufacturing,formulation, releasing test, storaging and stability, packaging and labeling. You can go to FDA website to see the regulatory guidance on CMC.

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• 回复：回复：哪个搞药的高人指点一下，什么是CMC ? -mybackyard- ♂ (471 bytes) () 03/19/2009 postreply 15:04:41