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首页> 美国卫生研究院文献>AAPS PharmSci >G.L. Amidon H. Lennernas V.P. Shah and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability Pharm Res 12 413–420 1995—Backstory of BCS
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G.L. Amidon H. Lennernas V.P. Shah and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability Pharm Res 12 413–420 1995—Backstory of BCS

机译：G.L. AmidonH.LennernasV.P。 Shah和J.R. Crison。生物制药药物分类的理论基础：体外药物产品溶解度与体内生物利用度的相关性Pharm Res 12413–4201995年– BCS的背景

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摘要

The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990–1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.
机译：今天，生物制药分类系统（BCS）在学术，工业和监管领域已被广泛接受。虽然BCS的最初应用是用于监管科学的生物等效性（BE）问题及其相关含义，但它已被制药业广泛地用于药物发现和开发中。这份简短的手稿将介绍BCS开发的故事。虽然BCS的许多基础工作都可以追溯到1970年代和1980年代Gordon Amidon（GLA）进行的药代动力学和药物吸收研究，但逐渐认识到需要对药物和药物产品进行分类或分类以设定溶出度标准在GLA在1990-1991年休假的FDA期间对GLA显而易见。应当时的CEDR董事Carl Peck博士的邀请，他开始成为FDA的访问科学家，其目的是促进FDA（就我而言）在生物制药方面的监管研究，并开发基于科学的系统简化法规要求。

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