临床前数据外推至临床现实:转化方法。

Prakhar Varshney, Phool Chandra
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引用次数: 0

摘要

体内研究比试管中的试验要复杂得多;其结果有时并不那么具有启发性,可能提出的问题多于答案。临床前数据投射到临床真相是一门转录科学,在药物开发过程中仍然是一项引人注目的试验。临床前体内和体外教育对新药的非暴力或活性生长非常重要。为了更好地了解药物及其代谢物的化学和生物效应,有必要进行药代动力学和代谢研究。这种政策所产生的信息可用于推进 I 期研究,主要是抗癌药物的研究。从理论上讲,活体和死体体外模型都是极好的临床前工具,可用于计算同科药物(如长春花生物碱)的药理作用。根据代谢模式选择与人类关系最密切的动物物种。药物作用持续时间的估算,尤其是对于代谢清除率不同的药物(如苯二氮卓类);药物关系的共鸣或估算,如环孢素 A 和大环内酯类抗生素的关系;以及药物作用个别不一致的代谢根源的澄清。
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Preclinical Data Extrapolation to Clinical Reality: A Translational Approach.

In vivo investigations are much more complex than trials conducted in a test tube; the results sometimes aren't as illuminating and could raise more questions than answers. Preclinical data projection into clinical truth is a transcriptional science that remains a compelling trial in drug development. Preclinical in vivo and in vitro education is important in novel drug's non-violent or active growth. Pharmacokinetic and metabolic research is necessary to better understand the chemical and biological effects of medicines and their metabolites. Information produced by such a policy can be used to progress Phase I studies, primarily for anticancer medication. Both living and deceased in vitro models are theoretically excellent preclinical tools for calculating the pharmacological action of counterparts from the same family, such as vinca alkaloids. The animal species most closely linked to humans are chosen based on metabolic patterns. The estimation of the duration of drug action, particularly for medicines with varied metabolic clearances (e.g., benzodiazepines); The empathetic or estimate of medicine relations, i.e., those defined for cyclosporin A and macrolide antibiotics; and Sclarification of the metabolic roots of individual inconsistencies in pharmaceutical action.

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