Translation of FDA Guiding Principles-Estimation of the maximum safe starting dose for the first dose in humans

Pharmaceutical technology review is based on science. From a scientific perspective, the technical guidelines developed by different countries and regions to guide research and development and evaluation can be used for reference to a large extent. At present, 56 technical guidelines have been drafted by our center and officially issued by the National Bureau. However, the areas and depth of the guidelines issued are far from the current demand for drug development and evaluation. Based on the above background, our center initiated the systematic translation and translation of foreign technical guidelines in early 2009.

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