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新药的临床研究包括临床试验与临床验证。临床试验一、Ⅰ期临床试验这期临床试验主要研究人对新药的耐受程度。提出新药安全有效的给药方案。主要针对中药某些含有毒性成份的新的中药制剂。 (一) 试验设计:须由有经验的主治医师和主管药师或相当职称的中医药人员根据中医药学的理论,结合临床经验从新药的理论性、客观性、药物的禁忌、用药剂量和给药途径等方面进行周密的试验设计,提
Clinical trials of new drugs include clinical trials and clinical validation. Clinical trials A phase Ⅰ clinical trial This phase of the clinical trial of the main study of new drug tolerance. Proposed new drugs safe and effective drug delivery program. Mainly for some traditional Chinese medicine containing toxic ingredients of new Chinese medicine preparations. (1) Experimental Design: The theory and objectivity of the new drug, taboo of the drug, dosing and administration of the new drug shall be determined by the experienced attending physician and the Chinese medicine practitioner in charge of the medicine or equivalent according to the theory of traditional Chinese medicine combined with clinical experience Ways and other aspects of careful test design, mention