Handbook of analytical quality by design / edited by Sarwar Beg [and three others].

Format:

Book

Contributor:

Beg, Sarwar, editor.

Language:

English

Subjects (All):

Pharmaceutical industry--Quality control.

Pharmaceutical industry.

Drug development--Quality control.

Drug development.

Drug development--Methodology.

Drugs--Design--Quality control.

Drugs.

Drugs--Design--Methodology.

Physical Description:

1 online resource (225 pages)

Place of Publication:

London, United Kingdom : Academic Press, an imprint of Elsevier, [2021]

Summary:

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.

Contents:

Introduction to analytical quality by design / Sarwar Beg [and 5 others]

Analytical quality by design for spectrophotometric method development / K.K. Lakshmi [and 6 others]

Analytical quality by design for gas chromatographic method deveopment / Rajesh Pradhan [and 4 others].

Notes:

1. Introduction to analytical quality by design -- 2. Analytical Quality by Design for spectrophotometric method development -- 3. Analytical Quality by Design for liquid chromatographic method development -- 4. Analytical Quality by Design for gas chromatographic method development -- 5. Analytical Quality by Design for size-exclusion chromatography -- 6. Analytical Quality by Design for ion-exchange chromatography -- 7. Analytical Quality by Design for LC-MS/MS method development -- 8. Analytical Quality by Design for HPTLC method development -- 9. Analytical Quality by Design for capillary electrophoresis -- 10. Quality by Design based development of vibrational spectroscopy methods -- 11. Quality by Design based development of atomic absorption spectroscopy methods -- 12. Quality by Design based development of non-destructive analytical techniques -- 13. Design space considerations for flexibility in analytical method development.

Description based on print version record.

ISBN:

9780128203330

0128203331

OCLC:

1233299779