Regulated drug bioanalysis for human pharmacokinetic studies and therapeutic drug management

Author:

Huang Yong1,Shi Robert2,Gee Winnie2,Bonderud Richard2

Affiliation:

1. Drug Studies Unit, Department of Bioengineering & Therapeutic Sciences, School of Pharmacy, University of California, San Francisco, CA 94143–0446, USA.

2. Drug Studies Unit, Department of Bioengineering & Therapeutic Sciences, School of Pharmacy, University of California, San Francisco, CA 94143–0446, USA

Abstract

Regulated drug bioanalysis (i.e., determination of drug concentrations in biological matrices for regulated studies) usually refers to animal toxicokinetics, bioavailability/bioequivalence and clinical pharmacokinetic studies. However, there is another important regulated drug bioanalysis – therapeutic drug management (TDM). In the USA, TDM is regulated by Clinical Laboratory Improvement Amendments. In this article, we review and compare human pharmacokinetic sample analysis and TDM sample analysis. The US FDA/Bioanalytical Method Validation Guidance and the American Association for Clinical Chemistry/TDM Roundtable Recommended Generic Assay Validation Guidance are also compared. Some regulated drug bioanalysis issues, such as terminology, validation concepts and acceptance criteria, are discussed. Fostering interaction between bioanalysts from pharmaceutical science and clinical chemistry and reducing the regulatory gaps between different agencies for drug bioanalysis is our objective.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference83 articles.

1. Development of bioanalysis: a short history

2. Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories

3. NosowskyR. Recent legal developments in academic research and clinical trials. Presented at:UC Compliance and Audit Symposium.Hilton San Francisco Airport, CA 94010, USA, 7–10 March 2011.

4. Historical perspective on the development and evolution of bioanalytical guidance and technology

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3