首页 | 本学科首页   官方微博 | 高级检索  
     


Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies
Authors:JoMarie Smolec  Binodh DeSilva  Wendell Smith  Russell Weiner  Marian Kelly  Ben Lee  Masood Khan  Richard Tacey  Howard Hill  Abbie Celniker  Vinod Shah  Ronald Bowsher  Anthony Mire-Sluis  John W. A. Findlay  Mary Saltarelli  Valerie Quarmby  David Lansky  Robert Dillard  Martin Ullmann  Stephen Keller  H. Thomas Karnes
Affiliation:(1) Amgen Inc., Thousand Oaks, California, USA;(2) Bowsher Brunelle Smith, Greenfield, Indiana, USA;(3) Bristol-Myers Squibb, Princeton, New Jersey, USA;(4) Centocor, Malvern, Pennsylvania, USA;(5) Alta Analytical Laboratory, San Diego, California, USA;(6) Pfizer Global Research and Development, Ann Arbor, Michigan, USA;(7) Covance Laboratories, Chantilly, Virginia, USA;(8) PPD Development, Richmond, Virginia, USA;(9) HLS, Alconbury, Cambridgeshire, UK;(10) Millennium Pharmaceuticals, Cambridge, Massachusetts, USA;(11) Food and Drug Administration, Rockville, Maryland, USA;(12) LINCO Diagnostic Services, St. Charles, Missouri, USA;(13) Pfizer Global Research, Groton, Connecticut, USA;(14) Abbott Laboratories, Abbott Park, Illinois, USA;(15) Genentech, San Francisco, California, USA;(16) Lansky Consulting LLC, Burlington, Vermont, USA;(17) Takeda Pharmaceuticals N.A., Lincolnshire, Illinois, USA;(18) MDS Pharma Services, Zurich, Switzerland;(19) Protein Design Labs, Inc., Fremont, California, USA;(20) Virginia Commonwealth University, Richmond, Virginia, USA;(21) 3985 Sorrento Valley Blvd, Ste C, San Diego, California 92121, USA
Abstract:The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.
Keywords:bioanalytical assay  biological matrices  immunoassay  method validation
本文献已被 PubMed SpringerLink 等数据库收录!
设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司  京ICP备09084417号