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Development and validation of analytical methods

Author: Christopher M Riley; Thomas W Rosanske
Publisher: Tarrytown, N.Y. : Pergamon, 1996.
Series: Progress in pharmaceutical and biomedical analysis, v. 3.
Edition/Format:   Print book : English : 1st edView all editions and formats
Database:WorldCat
Summary:

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because validated methods are a necessity for approvable  Read more...

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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Christopher M Riley; Thomas W Rosanske
ISBN: 0080427928 9780080427928
OCLC Number: 34357139
Description: x, 352 pages : illustrations ; 24 cm.
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.
Series Title: Progress in pharmaceutical and biomedical analysis, v. 3.
Responsibility: edited by Christopher M. Riley and Thomas W. Rosanske.
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G.P. Carr ...this book contains a great deal of material on applications of analytical methods which should be very valuable to analytical chemists employed within the pharmaceutical industry. Analyst Read more...

 
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