دانلود کتاب اعتبار سنجی روش در آنالیز دارویی: راهنمای بهترین عمل
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice 3rd Edition

New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2(R2) and Q14

Following a holistic lifecycle approach to analytical procedures, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis.

This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses hot topics in the field such as data integrity and continuous monitoring of analytical performance.

Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on relevant topics such as:

• Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle, and continued HPLC performance qualification
• Analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures
• Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy
• Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and a lifecycle approach to transfer of analytical procedures

Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QC and QA staff, and public authorities tasked with relevant regulatory responsibilities.

Contents

۱ Analytical Validation Within the Pharmaceutical Lifecycle
۲ Data Governance, Data Integrity, and Data Quality
۳ Analytical Instrument Qualification and System Validation Lifecycle
۴ Continued HPLC Performance Qualification
۵ Analytical Target Profile
۶ Decision Rules and Fitness for Intended Purpose
۷ Performance Characteristics of Analytical Procedures
۸ ICHQ14 Analytical Procedure Development
۹ Method Selection, Development, and Optimization
۱۰ Multivariate Analytical Procedures
۱۱ Case Study: Robustness Investigations
۱۲ Risk Assessment and Analytical Procedure Control Strategy
۱۳ ICH Q2(R2): Validation of Analytical Procedures
۱۴ Case Study: Validation of a High‐performance Liquid Chromatography (HPLC) Method for Identity, Assay, and Degradation of Products
۱۵ Case Study: Design and Qualification of a Delivered Dose Uniformity Procedure for a Pressurized Metered Dose Inhaler with a Focus on Sample Preparation
۱۶ Case Study: Validation of a Bioassay Method
۱۷ Implementation of Compendial/Pharmacopeia Test Procedures
۱۸ Transfer of Analytical Procedures
۱۹ Lifecycle Approach to Transfer of Analytical Procedures
۲۰ Continuous Improvements, Adjustments, and Changes
۲۱ Monitoring of Analytical Performance