Specification of Drug Substances and Products: Development and Validation of Analytical Methods - Image 1

£83.00

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

Name: Specification of Drug Substances and Products: Development and Validation of Analytical Methods
Brand: Elsevier
Price: 83.0 GBP
Availability: InStock

Pharmacy - Dispensing

Price History & Forecast

Last 34 days • 34 data points (No recent data available)

Historical

Generating forecast...

Price Distribution

Price distribution over 34 days • 1 price levels

Days at Price

Price Analysis

Most common price: £83 (34 days, 100.0%)

Price range: £83 - £83

Price levels: 1 different prices over 34 days

Description

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD) Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities Direct applicability to the day-to-day activities in drug development and the potential to increase productivity

Product Specifications

Brand: Elsevier
Format: Hardcover
ASIN: 0080983502
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 21 September 2013
Listed Since: 14 March 2013

Barcode

No barcode data available

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

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

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

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

Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Pharmaceutical Quality by Design: Principles and Applications

Analytical Chemistry in a GMP Environment: A Practical Guide

Analytical Techniques in the Pharmaceutical Sciences (Advances in Delivery Science and Technology)

Analytical Techniques in the Pharmaceutical Sciences (Advances in Delivery Science and Technology)

Pharmaceutical Quality by Design: A Practical Approach (Advances in Pharmaceutical Technology)

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development: 10 (AAPS Introductions in the Pharmaceutical Sciences, 10)

Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development: 10 (AAPS Introductions in the Pharmaceutical Sciences, 10)

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Wiley Analytical Testing for the Pharmaceutical GMP Laboratory

Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists

Validating Chromatographic Methods: A Practical Guide

NMR Spectroscopy in Pharmaceutical Analysis

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

Drugs and a Methodological Compendium: From bench to bedside

Handbook of Analytical Validation

Handbook of Analytical Validation

Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design

Methods for Stability Testing of Pharmaceuticals (Methods in Pharmacology and Toxicology)

Pharmaceutical Analysis (Sheffield Analytical Chemistry Series)