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Analytical method validation and instrument performance verification

紀錄類型:	書目-電子資源 : 單行本
正題名/作者:	Analytical method validation and instrument performance verification/ edited by Chung Chow Chan ... [et al.].
其他作者:	Chan, Chung Chow.
出版者:	Hoboken, N.J. :John Wiley & Sons,c2004.
面頁冊數:	1 online resource (x, 303 p.) :ill.
標題:	Drugs - Analysis -
電子資源:	Click here for online access to this book (查閱全文) (EBSCO eBook)
ISBN:	047146371X (electronic bk.)
ISBN:	9780471463719 (electronic bk.)
ISBN:	9780471463726
ISBN:	0471463728
ISBN:	0471259535 (print)
ISBN:	9780471259534 (print)

Analytical method validation and instrument performance verification
Analytical method validation and instrument performance verification[electronic resource] /edited by Chung Chow Chan ... [et al.]. - Hoboken, N.J. :John Wiley & Sons,c2004. - 1 online resource (x, 303 p.) :ill.

Includes bibliographical references and index.

Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen -- Potency method validation / Chung Chow Chan -- Method validation for HPLC analysis of related substances in pharmaceutical drug products / YC Lee -- Dissolution method validation / Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, Y.C. Lee.

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab s.

ISBN: 047146371X (electronic bk.)

Standard No.: 10.1002/0471463728doi

OverDrive, Inc.http://www.overdrive.comSubjects--Topical Terms:

1000064049
Drugs
--AnalysisIndex Terms--Genre/Form:

172687
Electronic books.

LC Class. No.: RS189 / .A568 2004eb

Dewey Class. No.: 610/.28

National Library of Medicine Call No.: 2004 C-229

Analytical method validation and instrument performance verification
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505 0 $a Development and validation of automated methods / Chantal Incledon and Herman Lam -- The analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang -- Validation study of JP heavy metal limit test / Yoshiki Nishiyama -- Bioanalytical method validation / Fabio Garofolo.
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