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Handbook of Analytical Validation

  • Livre Relié
  • 220 Nombre de pages
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Written for practitioners in drug and biotechnology industries, this title is designed to teach readers how to fully and correctly... Lire la suite
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Description

Written for practitioners in drug and biotechnology industries, this title is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. It offers the regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation.

"The authors are to be congratulated on producing a concise, readable and informative book. It is a really useful reference asset covering current regulatory requirements on the validation of new or modified analytical methods from a practical viewpoint. I have seen books of almost twice the size containing half the information. This book should be an integral part of all drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV."
www.chemistryworld.org 1 November 2012 1 Chemistry World 163



Auteur

Northeastern University, Boston, Massachusetts, USA Synomics Pharmaceuticals Svcs LLC, Massachusetts, USA



Texte du rabat

<P>Written for both the drug and biotechnology industries, this handbook has been carefully designed to instruct readers as to the current, regulatory requirements to correctly and properly validate a new or modified analytical method. The book contains the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. It is designed for both small molecules in the conventional pharmaceutical industry, as well as for biopolymers derived from the biopharmaceutical industry. The book is designed to educate the reader into how to fully and correctly modify new or modified analytical methods to meet regulatory requirements.</P>

Résumé

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 of methods used in the regulatory environment

    Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.



    Contenu

    Introduction to Analytical Method Validation
    Introduction
    The Drug Development Process
    FDA Hierarchy and Organization
    The International Conference on Harmonization
    AMV Guidance
    The Validation Process
    Training
    Conclusion

    Analytical Instrument Qualification
    Introduction
    Components of Data Quality
    The AIQ Process
    Roles and Responsibilities
    Software Validation and Change Control
    AIQ Documentation
    Instrument Categories
    Conclusion

    HPLC Method Development and Optimization with Validation in Mind
    Introduction
    HPLC Method Development Approaches
    Method Goals
    HPLC Method Development Instrumentation
    Method Optimization
    Summary

    Method Validation Basics
    Introduction
    Method Validation Guidelines
    Terms and Definitions
    Validation According to Method Type
    Documentation
    Summary

    Robustness and System Suitability
    Introduction
    Robustness Studies for Method Validation
    Robustness Study Experimental Design
    Analyzing the Results
    Documentation and Reporting
    System Suitability Tests
    System Suitability Standards
    System Suitability Protocol
    Method Adjustments to Meet System Suitability Requirements
    Conclusion

    Setting Specifications and Investigating Out-of-Specification Results
    Introduction
    Guidance for Setting Specifications
    General Concepts for Developing and Setting Specifications
    Universal Tests/Criteria
    Specific Tests/Criteria: New Drug Substances
    Specific Tests/Criteria: New Solid Oral Drug Products
    Specific Tests/Criteria: New Oral Liquid Drug Products
    Specific Tests/Criteria: Parenteral Drug Products
    Decision Trees
    OOS Background
    Preventing OOS Results
    Identifying and Assessing OOS Test Results
    Investigating OOS Test Results
    Concluding the OOS Investigation

    Validation by Type of Method
    Introduction
    Validation of Impurity Methods
    Developing and Validating SIMs
    Developing and Validating Dissolution Procedures
    Bioanalytical Methods
    Validating Peptide Mapping Methods
    Cleaning Method Validation

    Analytical Method Transfer
    Introduction
    Terms, Definitions, and Responsibilities
    Analytical Method Transfer Options
    Documentation of Results: The AMT Report
    Potential AMT Pitfalls

    Implementing New Technology in a Regulated Environment
    Introduction
    Changes to an Approved Method
    What Constitutes a Change to a Method?
    Implement an Existing Standard Method
    Implement an Existing Standard Method with Adjustments
    Implement an Existing Standard Method with Changes

    Glossary of Terms Related to Chromatographic Method Validation

    Appendix 1
    Example Method Validation Protocol

    Informations sur le produit

    Titre: Handbook of Analytical Validation
    Auteur:
    Code EAN: 9780824706890
    ISBN: 978-0-8247-0689-0
    Format: Livre Relié
    Editeur: Taylor and Francis
    Genre: Technique chimie
    nombre de pages: 220
    Poids: 512g
    Taille: H235mm x B156mm
    Année: 2012

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