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Handbook of analytical validation / Michael E. Swartz, Ira S. Krull.

By: Contributor(s): Material type: TextTextPublication details: Boca Raton, FL : CRC Press, c2012.Description: xiv, 206 p. : ill. ; 25 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 9780824706890 (hardback : acidfree paper)
Subject(s): DDC classification:
  • 543 23 S.M.H
LOC classification:
  • QD75.4.Q34 S93 2012
Online resources:
Contents:
Front Cover; Contents; Preface; Chapter 1: Introduction to Analytical Method Validation; Chapter 2: Analytical Instrument Qualification; Chapter 3: HPLC Method Development and Optimization with Validation in Mind; Chapter 4: Method Validation Basics; Chapter 5: Robustness and System Suitability; Chapter 6: Setting Specifications and Investigating Out-of-Specification Results; Chapter 7: Validation by Type of Method; Chapter 8: Analytical Method Transfer; Chapter 9: Implementing New Technology in a Regulated Environment; Glossary of Terms Related to Chromatographic Method Validation
Summary: Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types
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Holdings
Item type Current library Collection Call number Status Date due Barcode
Books Books Main library A9 Pharmacy ( Pharmaceutical chemistry ) 543 S.M.H (Browse shelf(Opens below)) Available 00009683

Includes bibliographical references and index.

Front Cover; Contents; Preface; Chapter 1: Introduction to Analytical Method Validation; Chapter 2: Analytical Instrument Qualification; Chapter 3: HPLC Method Development and Optimization with Validation in Mind; Chapter 4: Method Validation Basics; Chapter 5: Robustness and System Suitability; Chapter 6: Setting Specifications and Investigating Out-of-Specification Results; Chapter 7: Validation by Type of Method; Chapter 8: Analytical Method Transfer; Chapter 9: Implementing New Technology in a Regulated Environment; Glossary of Terms Related to Chromatographic Method Validation

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types

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