Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Late Knight Books
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US $211.00
ApproximatelyRM 888.10
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Located in: Lansdale, PA, United States
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eBay item number:357181793640
Last updated on Oct 06, 2025 22:52:00 MYTView all revisionsView all revisions

Item specifics

Condition
Brand New: A new, unread, unused book in perfect condition with no missing or damaged pages. See all condition definitionsopens in a new window or tab
Educational Level
Adult & Further Education
Personalized
No
Level
Advanced
Country/Region of Manufacture
Germany
ISBN
9783527348909
Category

About this product

Product Identifiers

Publisher
Wiley & Sons, Incorporated, John
ISBN-10
3527348905
ISBN-13
9783527348909
eBay Product ID (ePID)
25070471323

Product Key Features

Number of Pages
544 Pages
Publication Name
Method Validation in Pharmaceutical Analysis : a Guide to Best Practice
Language
English
Subject
Pharmacology
Publication Year
2025
Type
Textbook
Subject Area
Medical
Author
Phil W. Nethercote
Format
Hardcover

Dimensions

Item Height
0.6 in
Item Weight
24.1 Oz
Item Length
9.6 in
Item Width
6.7 in

Additional Product Features

Edition Number
3
Intended Audience
Scholarly & Professional
Dewey Edition
22
Dewey Decimal
615.1901
Synopsis
New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14 Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualification Analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities., New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2 and Q14 Following an all-encompassing lifecycle approach to analytical procedures in pharmaceutical analysis, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis. This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP Validation & Verification Expert Panel on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses trending topics in the field such as data integrity and continuous monitoring of analytical performance. Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on sample topics such as: Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle Continued HPLC performance qualification, analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and the lifecycle approach to transfer of analytical procedures Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QA officers, and public authorities tasked with relevant regulatory responsibilities.

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Late Knight Books

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