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Information List

Japan's Shimadzu to buy clinical isotope labeling company AlsaChim

2018-10-25

Instrument Information Network 2017/06/22 [Introduction] In the face of the global wave of clinical mass spectrometry, even Shimadzu, which rarely participates in capital operation, has recently revealed acquisition news: Shimadzu announced that it has wholly acquired AlsaChim, an independent contract research and development institution in France, through Shimadzu Europe. The global scientific instrument industry is changing, and the merger and acquisition integration between enterprises is continuous. However, compared with the "frequent moves" of European and American companies such as Syme Fly and Danaher, the mergers and acquisitions of Japanese companies appear to be "implicit" a lot. Nevertheless, in the face of global clinical mass spectrometry waves.

China's Food and Drug Administration Becomes a Full Member of the International Technical Coordination Committee for Registration of Medicines for Human Use (ICH)

2018-10-25

On June 19, 2017, the State Food and Drug Administration announced that it has become a full member of the International Technical Coordination for Registration of Medicines for Human Use (ICH). It means that China's drug regulatory authorities, pharmaceutical industry and R & D institutions will gradually transform and implement the highest international technical standards and guidelines, and actively participate in the formulation of rules, which will promote innovative drugs to meet the clinical drug needs of patients at home and abroad as soon as possible, and enhance the innovation ability and international competitiveness of the domestic pharmaceutical industry. ICH was established in 1990 by the United States, the European Community and Japan tripartite drug regulatory authorities and industry associations, and in.

Ministry of Agriculture "Guidelines for Metabolic Testing of Pesticides in Plants" (draft for comments)

2018-10-25

Excerpt: Issued by: Ministry of Agriculture of China Issued on May 7, 2017. Isotope labeling synthesis of 3.2 pesticides The process of isotope labeling synthesis of pesticide molecules (stable skeletons) using radioactive and (or) stable isotopes to obtain 13C, 14C, 15N and 35S labeled pesticide compounds. In general, 14C is preferred, and when the molecule contains no carbon atoms or only unstable carbon-containing side chains, 35S or other radioactive isotopes are contemplated. Stable isotopes (such as 13C and 15N) are used together with radioactive isotopes to help metabolism

Technical guidelines for non-clinical pharmacokinetic studies of drugs

2018-10-25

Excerpt: Release Unit: china food and drug administration Release Date: May 13, 2014 2. Selection of Radioisotope Labeling Methods Low-energy radioisotopes commonly used in ADME research of small molecule chemical drugs are carbon -14(14C) and tritium (3H). 14C labeling is the most commonly used, its biological background is low, biology almost no isotope effect and affect metabolism, rarely occur isotope exchange, sensitivity is higher than 3H and easy to quantify. Metabolically stable sites should be selected when labeling carbon -14 compounds. In vivo testing unless 14C labeling is very difficult or

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