Multivariate Analysis in the Pharmaceutical Industry

ISBN: 9780128110652 出版年：2018 页码：465 Academic Press_RM

Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challengesIncludes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applicationsContains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come