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新药的药理毒理学研究是新药研究的重要组成部份，其中主要药效学研究应该用体内、体外两种以上试验方法证明，其中一种必须是整体的正常动物或动物病理模型。试验时注意选择合理的动物种属、品系，合理的给药剂量和观察时间。一般药理研究包括精神神经系统，心血管系统、呼吸系统，有时尚需根据药品特点进行其它有关项目的研究。毒理学研究包括急性毒性、长期毒性和局部用药毒性研究。长期毒性研究观察时间要根据实际情况而定。局部用药毒性研究，要注意局部的吸收、刺激、致敏等。在特殊毒性研究中应特别注意选择合适的实验动物。
Pharmacology and toxicology of new drugs is an important part of the new drug research, of which the main pharmacodynamic studies should be more than two in vitro and in vivo test methods to prove that one must be the overall normal animal or animal pathology model. Test attention to choose a reasonable animal species, strains, a reasonable dose and observation time. General pharmacological studies include the nervous system, cardiovascular system, respiratory system, there are times when other related items need to be studied according to the characteristics of the drug. Toxicology studies include acute toxicity, long-term toxicity and topical toxicity studies. Long-term toxicity study observation time to be based on the actual situation. Topical toxicity study, pay attention to local absorption, stimulation, sensitization and so on. Particular attention should be paid to the selection of suitable laboratory animals for special toxicity studies.