Preclinical Drug Development

Krishna Tanneru
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Abstract

Preclinical drug development incorporates the activities that link to the discovery of drug in the laboratory to human clinical trials. Before the clinical trials, tests and treatments are assessed in the research of preclinical. Preclinical research is not done with the persons. Preclinical studies also designed to identify the lead candidate from many hits; to develop the best procedure for new drug scale-up; to select the best formulation; to determine the route, frequency, and duration of exposure; and support the intended clinical trial design ultimately. The specifics of each preclinical development package may vary, but all have few common features.
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临床前药物开发
临床前药物开发包括将实验室药物发现与人体临床试验联系起来的活动。在临床试验之前,在临床前研究中对试验和治疗进行评估。临床前研究不是对人进行的。临床前研究还旨在从许多热门药物中确定主要候选药物;制定新药规模化生产的最佳流程;选择最佳配方;确定接触的途径、频率和持续时间;并最终支持预期的临床试验设计。每个临床前开发包的具体情况可能有所不同,但都有一些共同的特点。
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