Coverart for item
The Resource Development and validation of analytical methods, edited by Christopher M. Riley and Thomas W. Rosanske, (electronic book)

Development and validation of analytical methods, edited by Christopher M. Riley and Thomas W. Rosanske, (electronic book)

Label
Development and validation of analytical methods
Title
Development and validation of analytical methods
Statement of responsibility
edited by Christopher M. Riley and Thomas W. Rosanske
Contributor
Subject
Language
eng
Summary
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation
Member of
Cataloging source
OPELS
Dewey number
615/.1901
Illustrations
illustrations
Index
index present
LC call number
RS189
LC item number
.P442 1996eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/relatedWorkOrContributorName
  • Riley, Christopher M
  • Rosanske, Thomas W
Series statement
Progress in pharmaceutical and biomedical analysis
Series volume
3
http://library.link/vocab/subjectName
  • Drugs
  • Chemistry, Pharmaceutical
  • Pharmaceutical Preparations
Label
Development and validation of analytical methods, edited by Christopher M. Riley and Thomas W. Rosanske, (electronic book)
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
Section headings and papers: List of Contributors. Introduction. Basic Concepts. Assay validation and inter-laboratory transfer (E. McGonigle). Statistical parameters and analytical figures of merit (C.M. Riley). Regulatory Considerations. Overview of worldwide regulations (I.E. Davidson). Issues related to United States v. Barr Laboratories Inc. (C.L. Burgess). Judge Wolin's interpretations of current good manufacturing practice issues contained in the court's ruling in the United States v. Barr Laboratories (R.J. Davis). Specific Methods and Applications. Bulk drug substances and finished products (P.K. Hovsepian). Dissolution studies (T.W. Rosanske, C.K. Brown). Robotics and automated workstations (J.J. Tomlinson). Biotechnology products (G.S. Srivatsa). Biological samples (K.A. Selinger). Analytical methods for cleaning procedures (T.M. Rossi, R.R. Ryall). Computer systems and computer-aided validation (J.G. Liscouski). Index
Control code
SCIDI162565745
Dimensions
unknown
Edition
1st ed.
Extent
1 online resource (x, 352 p.)
Form of item
online
Isbn
9780080530352
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Other physical details
ill.
Specific material designation
remote
Label
Development and validation of analytical methods, edited by Christopher M. Riley and Thomas W. Rosanske, (electronic book)
Publication
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Contents
Section headings and papers: List of Contributors. Introduction. Basic Concepts. Assay validation and inter-laboratory transfer (E. McGonigle). Statistical parameters and analytical figures of merit (C.M. Riley). Regulatory Considerations. Overview of worldwide regulations (I.E. Davidson). Issues related to United States v. Barr Laboratories Inc. (C.L. Burgess). Judge Wolin's interpretations of current good manufacturing practice issues contained in the court's ruling in the United States v. Barr Laboratories (R.J. Davis). Specific Methods and Applications. Bulk drug substances and finished products (P.K. Hovsepian). Dissolution studies (T.W. Rosanske, C.K. Brown). Robotics and automated workstations (J.J. Tomlinson). Biotechnology products (G.S. Srivatsa). Biological samples (K.A. Selinger). Analytical methods for cleaning procedures (T.M. Rossi, R.R. Ryall). Computer systems and computer-aided validation (J.G. Liscouski). Index
Control code
SCIDI162565745
Dimensions
unknown
Edition
1st ed.
Extent
1 online resource (x, 352 p.)
Form of item
online
Isbn
9780080530352
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Other physical details
ill.
Specific material designation
remote

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