Advanced Analytical Validation Tapa dura - 2010 - 1st Edición
de Chan; Lam; Zhang
Descripción de contraportada
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements
Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification.
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Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems
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Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance--coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers--and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs
At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP).
Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
Detalles
- Título Advanced Analytical Validation
- Autor Chan; Lam; Zhang
- Encuadernación Tapa dura
- Número de edición 1st
- Edición 1
- Páginas 416
- Volúmenes 1
- Idioma ENG
- Editorial John Wiley & Sons
- Fecha de publicación 2010-09-27
- Features Bibliography, Index
- ISBN 9780470121948 / 0470121947
- Peso 1.67 libras (0.76 kg)
- Dimensiones 9.4 x 6.4 x 1.1 pulgadas (23.88 x 16.26 x 2.79 cm)
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Temas
- Aspects (Academic): Science/Technology Aspects
- Library of Congress subjects Chemistry, Pharmaceutical - methods, Technology, Pharmaceutical - methods
- Número de catálogo de la Librería del Congreso de EEUU 2009054243
- Dewey Decimal Code 615.190
Reseñas en medios
Citas
- Scitech Book News, 12/01/2010, Page 122
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