指导原则编号 PHARMACOKINETICS AND METABOLIC STUDIESIN THE SAFETY EVALUATION OF NEW MEDICINAL PRODUCTS IN ANIMALS 化学药物非临床药代动力学研究 技术指导原则 第三稿 Guideline title Pharmacokinetics and Metabolic Studies in the Safety Evaluation of New Medicinal Products in animals sative basis Directive 75/31&EEC as amended Date of first adoption October 1983 Date of entry into force April 1994 Last revised 1983 Previous titles other none references Additional Notes This note for guidance concerns the application of Part3, section ll G of the annex to directive 75318 EEC as mended with a view to the granting of a marketing authorisation for a medicinal product. Sections of this text have been revised as part of the ICH process. The relevant parts of this guideline may be replaced by the notes for guidance on The Assessment of Systemic Exposure in Toxicity 二OO四年九月 Studies and on Repeated Dose Tissue Distribution Studies