Development and Validation of Analytical Methods (Record no. 11775)

000 -LEADER
fixed length control field 03959nam a2200193Ia 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 140223b1996 xxu||||| |||| 00| 0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9780080427928
Terms of availability 0.00
082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.1901
Item number DEV
100 ## - MAIN ENTRY--PERSONAL NAME
Personal name Riley, Christopher M.
245 ## - TITLE STATEMENT
Title Development and Validation of Analytical Methods
Statement of responsibility, etc. Ed by Christopher M.Riley and Thomas W.Rosanske
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc. New York
Name of publisher, distributor, etc. Elsevier Science Inc.
Date of publication, distribution, etc. 1996
300 ## - PHYSICAL DESCRIPTION
Extent 352p
500 ## - GENERAL NOTE
General note 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.
600 ## - SUBJECT ADDED ENTRY--PERSONAL NAME
Personal name Chemical Analysis
700 ## - ADDED ENTRY--PERSONAL NAME
Personal name Rosanske, Thomas W.
890 ## -
-- USA
995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE]
-- DEV
-- 004140
-- PHA-NIP
-- 4489.48
-- 0
-- 049
-- 33239
-- 0
-- 0.00
-- 20060105
-- 1
-- C
-- 20060112
-- Books IndiaP
-- Reference
995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE]
-- DEV
-- 009289
-- ANB-ANA
-- 1106.30
-- 0
-- 049
-- EBC39889
-- 0
-- 0.00
-- 1495.00 26%
-- 20100317
-- 01
-- C
-- 20100330
-- Educational Book Centre
-- General
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection code Permanent Location Current Location Shelving location Date acquired Source of acquisition Cost, normal purchase price Full call number Barcode Date last seen Price effective from Koha item type Total Checkouts Total Renewals Date checked out
      Not For Loan Reference Institute of Pharmacy Institute of Pharmacy   2006-01-12 Books IndiaP 4489.48 615.1901 DEV P0002205 2014-06-19 2014-06-19 Book      
        General Institute of Pharmacy Institute of Pharmacy   2010-03-30 Educational Book Centre 1106.30 615.1901 DEV P0007368 2016-10-18 2014-06-19 Book 3 1 2016-09-26

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