The Bioanalysis Glossary
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The Bioanalysis Glossary Contents The Bioanalysis Glossary November 2014 Bioanalysis Vol. 6 No. 16 Suppl. 1 Brought to you by Bioanalysis and Bioanalysis Zone S5 FOREWORD S6 SCOPE S7 TERMS & DEFINITIONS S84 INDEX S89 COMPANY PROFILES Publishing information ISBN PDF: 978-1-910420-53-2 ISBN ePub: 978-1-910420-53-9 ISBN print: 978-1-910420-54-6 Publication history First edition published November 2014 S3 Bioanalysis (2014) 6(16) Suppl. 1 future science group The Bioanalysis Glossary Editorial Panel Bioanalysis Glossary Editorial Panel Chairman The Glossary Editorial Panel is drawn from the leading James Drake forces in bioanalysis Managing Director Phil Garner Arnold ME, Bristol-Myers Squibb Co., USA COMMISSIONING DEPARTMENT Bansal S, Roche, USA Senior Manager: Booth B, US FDA, USA Commissioning & Journal Development Borenstein M, Temple Univ., USA Laura Dormer Commissioning Editor Declerck P, KU Leuven, Belgium Kasumi Crews Ezan E, CEA, France Bethany Small Glossary Editor Findlay J, Independent Consultant, USA Ryan De Vooght-Johnson Garrett TJ, Univ. of Florida, USA PRODUCTION Kissinger PT, Purdue Univ., USA DEPARTMENT MacNeill R, Huntingdon Life Sciences, USA Senior Manager: Production Meesters R, Univ. de los Andes, Colombia Kathryn Berry Graphics & Design Rudaz S, Univ. of Geneva, Switzerland Clare Dolan Sangster T, Charles River Laboratories, UK Tulsi Voralia Sleno L, Univ. du Québec a Montreal (UQAM), ADVERTISING ENQUIRIES Canada Advertising Smeraglia J, UCB, Belgium Dionne Murray, Business Development Manager Stove C, Univ. of Ghent, Belgium [email protected] Timmerman P, Johnson & Johnson, Belgium Editorial Laura Dormer, van de Merbel N, PRA International, The Netherlands Senior Manager [email protected] Weng N, Johnson & Johnson, USA Subscriptions Woolf E, Merck, USA Dominik March, Subscription Sales Manager Zhong D, Shanghai Institute of Materia Medica, China [email protected] Reprints Sam Cavana, Reprint Sales Manager [email protected] Permissions Pamela Cooper, Publishing Administrator [email protected] S4 Bioanalysis (2014) 6(16) Suppl. 1 future science group The Bioanalysis Glossary Editorial Panel Bioanalysis Senior Editors Brian Booth, US FDA, Division of Clinical Pharmacology 5, MD, USA Neil Spooner, GlaxoSmithKline, UK Bioanalysis Associate Editors David A Barrett, Univ. of Nottingham, UK Howard Hill, Huntingdon Life Sciences, UK Michael R Borenstein, Temple Univ., PA, USA Michael E Hodson, Yale Univ. School of Medicine, Ajai K Chaudhary, Merck & Co. Inc., PA, USA CT, USA Ulrich Flenker, German Sport Univ., Germany Marcel Florin Musteata, Albany College of Sanjay Garg, Univ. of South Australia, Australia Pharmacy and Health Sciences, NY, USA Fabio Garofolo, Algoithme Pharma Inc., Canada Dafang Zhong, Shanghai Institute of Materia Melissa Hanna-Brown, Pfizer, UK Medica, China Bioanalysis Editorial Advisory Panel The Editorial Panel is drawn from the leading forces in bioanalysis Bradley L Ackermann, Eli Lilly and Company, IN, Wolfram Meier-Augenstein, James Hutton USA Institute, UK Hyun Joo An, Chungnam National Univ., Korea Yvette Michotte, Vrije Univ. Brussels, Belgium Mark Arnold, Bristol-Myers Squibb, NJ, USA Ramesh Mullangi, Jubilant Biosys Ltd, India Bonnie A Avery, Univ. of Mississippi, MS, USA Nicole Pamme, Univ. of Hull, UK Kevin Bateman, Merck & Co., PA, USA Valentina Porta, Univ. of São Paulo, Brazil Jonas Bergquist, Uppsala Univ., Sweden Gregory T Roman, Waters Corporation, MA, USA Ravi Bhushan, Indian Institute of Technology Patrick Schamasch, International Olympic Roorkee, India Committee, Switzerland Gary Bowers, GlaxoSmithKline, NC, USA Vinod P Shah, Independent Consultant, USA Daniel G Bracewell, Univ. College London, UK Gopi Shankar, Janssen R&D LLC, PA, USA Patrick Camilleri, Biochemical Solutions, UK Dennis Smith, Independent, UK Min Chang, Biogen Idec, MA, USA Graeme Smith, Huntingdon Life Sciences, UK Binodh DeSilva, Bristol-Myers Squibb, NJ, USA Nuggehally R Srinivas, Suramus Biopharm, India Anthony DeStefano, US Pharmacopoeia, MD, USA Roland Staack, Roche Diagnostics GmbH, Germany John CL Erve, Elan, CA, USA Derek Stevenson, Univ. of Surrey, UK Perry Fan, Abbott, IL, USA Roman Szucs, Pfizer, UK Joe P Foley, Drexel Univ., PA, USA Koli Taghizadeh, Massachusetts Institute of Frank A Gomez, California State Univ., CA, USA Technology, MA, USA Erin Gross, Creighton Univ., NE, USA Daniel Tang, ICON plc, China David S Hage, Univ. of Nebraska, NE, USA Philip Timmerman, Johnson & Johnson, Belgium John McKnight Halket, King’s College London, UK Danyelle Townsend, Medical Univ. South Carolina, Yunsheng Hsieh, Merck, NJ, USA SC, USA Andrew J Hutt, Univ. of Hertfordshire, UK Dieter Trau, National Univ. of Singapore, Singapore Berit P Jensen, Univ. of Otago, New Zealand Nico van de Merbel, PRA International, The Michael A Johnson, Univ. of Kansas, KS, USA Netherlands Hiroshi Kamimori, Shionogi & Co., Ltd, Japan Dajana Vuckovic, Univ. of Toronto, Canada Prashant Kole, Queen’s Univ. Belfast, UK Perry Wang, US FDA, USA Walter Korfmacher, Genzyme/Sanofi, MA, USA Michael G Weller, BAM Federal Institute for Graham Lappin, Xceleron, UK Materials Research & Testing, Germany Hye Suk Lee, Wonk Wang Univ., South Korea Pat Wright, Univ. of Greenwich, UK Haitao Lu, Chongqing Univ. Innovative Drug Re- Fengguo Xu, China Pharmaceutical Univ., China search Center, China Michael Zhou, Pars Pharma Consulting, CT, USA Gabriel Marcelín-Jiménez, Global Bioanalytical Dieter Zimmer, Zimmer BioAnalytics & More, Consulting, México Switzerland Marco Mascini, Univ. of Firenze, Italy Andrei Valentin Medvedovici, Univ. of Bucharest, Romania S5 Bioanalysis (2014) 6(16) Suppl. 1 future science group The Bioanalysis Glossary Sponsors Disclaimer Sponsors did not participate in the compilation or editing of this glossary. Sponsored terms were selected by sponsors from the final edited list which was compiled by the Future Science editorial team and a panel of experts in bioanalysis. Copyright Conditions of sale: This glossary may be circulated only to those members of staff who are employed at the site at which the subscription is taken out. Readers are reminded that, under internationally agreed copyright legislation, photocopying of copyright materials is prohibited other than on a limited basis for personal use. Thus, making copies of any article published in Bioanalysis is a breach of the law and can be prosecuted. This glossary has been produced in partnership with: Future Science Ltd Unitec House 2 Albert Place London, N3 1QB, UK Editorial Tel.: +44 (0)20 8371 6090 Fax: +44 (0)20 8343 2313 Customer Services Tel.: +44(0)20 8371 6080 Fax: +44 (0)20 8371 6099 Email: [email protected] www.future-science.com S6 Bioanalysis (2014) 6(16) Suppl. 1 future science group The Bioanalysis Glossary Foreword FOREWORD The Bioanalysis Glossary An essential new resource for bioanalysts! The Future Science editorial team is development and other related fields such delighted to bring you the first edition of as metabolomics, antidoping testing and The Bioanalysis Glossary, which we hope therapeutic drug monitoring – important will be regarded as an essential resource terminology relevant to bioanalysis has for everyone who works in bioanalysis or also been included. This reinforces the fact related fields. Over 20 leading bioanalytical that bioanalysis involves much more than experts from industry and academia have just providing data – bioanalysts should been working closely with the Future be actively engaged in discussions relating Science editorial team over several months to all stages of drug development, and a to develop this definitive glossary. better understanding of related areas such This guide will be particularly useful as pharmacokinetics and how the data will for those moving into the field or working be used leads to more insightful and useful with bioanalytical laboratories for the first bioanalyses. time, and as a reference for experienced Therefore, this glossary includes core bioanalysts writing reports, research papers established bioanalytical terminology, or presentations. Importantly, this glossary as well as definitions from related fields will aid in harmonization of the terminology (e.g., pharmacokinetics and