Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
Author :
Publisher : Academic Press
Total Pages : 225
Release :
ISBN-10 : 9780128203330
ISBN-13 : 0128203331
Rating : 4/5 (331 Downloads)

Book Synopsis Handbook of Analytical Quality by Design by : Sarwar Beg

Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance


Handbook of Analytical Quality by Design Related Books

Handbook of Analytical Quality by Design
Language: en
Pages: 225
Authors: Sarwar Beg
Categories: Science
Type: BOOK - Published: 2021-01-09 - Publisher: Academic Press

DOWNLOAD EBOOK

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in la
Pharmaceutical Quality by Design
Language: en
Pages: 450
Authors: Sarwar Beg
Categories: Medical
Type: BOOK - Published: 2019-03-27 - Publisher: Academic Press

DOWNLOAD EBOOK

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the dev
Handbook of Pharmaceutical Wet Granulation
Language: en
Pages: 894
Authors: Ajit S. Narang
Categories: Medical
Type: BOOK - Published: 2018-08-31 - Publisher: Academic Press

DOWNLOAD EBOOK

Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all asp
Method Validation in Pharmaceutical Analysis
Language: en
Pages: 418
Authors: Joachim Ermer
Categories: Science
Type: BOOK - Published: 2006-03-06 - Publisher: John Wiley & Sons

DOWNLOAD EBOOK

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calcu
Handbook of Analytical Validation
Language: en
Pages: 218
Authors: Michael E. Swartz
Categories: Medical
Type: BOOK - Published: 2012-04-24 - Publisher: CRC Press

DOWNLOAD EBOOK

Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and p