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China Food and Drug Administration published eight technical research guidelines drug safety pharmac
Date: 2016-04-22
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By the Center for Drug Evaluation responsible for drafting the "drug safety pharmacology research technical guidelines" and eight technical guidelines have been China Food and Drug Administration approved on May 13 officially released.

8 Technical guidelines for the release, including "drug safety pharmacology technical research guidelines," "Drug Single dose toxicity studies technical guidelines", "pharmaceutically repeated dose toxicity study technical guidelines", "non-drugs clinical pharmacokinetics of technical guidelines "and" Drug irritation, sensitization, hemolysis of technical guidelines "and other five technical guidelines is the 2005 national Bureau were developed medicine, natural medicine and chemical drugs nonclinical the combined security technology research guidelines. The new formulation of "drug toxicokinetic studies technical guidelines", "Drug QT prolongation potential role of non-clinical studies technical guidelines" and "non-clinical drug safety evaluation for the sample testing requirements Q & A", is based on international pharmaceutical non-clinical safety evaluation of the key issues of the current awareness, combined with the future development of China's non-clinical drug safety evaluation made.

Released these guidelines will help improve China's pharmaceutical non-clinical safety evaluation of scientific and normative, and lay an important foundation for the further improvement of the system guidelines. Learn "drug safety pharmacology research technical guidelines" and eight technical guidelines for specific content, please visit the State Food and Drug Administration website.

 

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