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Elsevier Specification of Drug Substances and Products: Development and Validation of Analytical Methods

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Last 609 days • 609 data points (No recent data available)

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£143.87 £11.94 £40.72 £69.51 £98.29 £127.08 £155.86 09 June 2024 08 November 2024 09 April 2025 08 September 2025 07 February 2026

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161 days · current 115 days 41 days 234 days 58 days 0 59 117 176 234 £24-48 £48-72 £72-96 £96-120 £120-144 Days at Price

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Most common range: £96-120 (234 days, 38.4%)

Price range: £24 - £144

Price levels: 5 price ranges over 609 days

Description

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.

Product Specifications

Format
Paperback
Domain
Amazon UK
Release Date
24 July 2020
Listed Since
16 January 2019

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