Method Validation In Pharmaceutical Analysis A Guide To Best Practice - April 2024

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives... [Read More]

• ASIN: 3527335633
• ASIN: 3527335633
• ISBN: 9783527335633
• Manufacturer: Wiley-VCH

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-... [Read More]

• ASIN: 3527312552
• ASIN: 3527312552
• ISBN: 3527312552
• Manufacturer: Wiley-VCH

Method Validation in Pharmaceutical Analysis - eBook

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing.As in the first edition, the

• UPC: 916860322

Validation of Analytical Methods for Pharmaceutical Analysis

This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this

• UPC: 53376903

HPLC Method Development and Validation in Pharmaceutical Analysis

HPLC Method Development and Validation in Pharmaceutical

• UPC: 53655217

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice by Ermer

• UPC: 283479545142
• Category: Nonfiction
• Price: 209 USD

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice by Joachi

• UPC: 362920396170
• Category: Nonfiction
• Price: 252 USD

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice.

• UPC: 184134418793
• Category: Non-Fiction Books
• Price: 297 AUD