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Theory of Sampling (TOS): A necessary and sufficient guarantee for reliable multivariate dara analysis in pharmaceutical manufacturing

By Esbensen, Kim H; Romañach, Rodolfo; J.Ferrerira, Ana P.; Menezes, Jose C.; Tobyn, Mike; Román-Ospino, Andrés D.

Published on CMKC

Abstract

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.

Journal

Academic Press. 2018, 53-91

DOI

10.1016/b978-0-12-811065-2.00005-9

Type of publication

Chapter Book

Affiliations

  • KHE Consulting
  • University of Puerto Rico at Mayagüez
  • Rutgers, The State University of New Jersey

Article Classification

Other

Classification Areas

  • PAT
  • Oral

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