By Mary Beth Lewis, GlaxoSmithKline; Brian Griner, Ph.D., Quintiles; and Mridul Malhotra, Quintiles
Demonstrating the value of therapies to the many healthcare stakeholders is an ongoing challenge for drugmakers. This involves complex analytics and requires developing appropriate evidence to meet stakeholder needs.
By James Drinkwater, Bioquell UK Process and Compliance Director
This paper reviews the background to false positives and false negatives associated with the sterility test process. It explores the potential causes of such results and suggests methods of mitigation.
By Malcolm McLaughlin, Alconox
Typically, pharmaceutical operations require transition from bench-scale R&D, to pilot studies, to full-scale manufacturing. Each transitional stage requires careful consideration of changes to the processing equipment and cleaning techniques.
By Hemi Sagi, Director, ATC, Inc.
Great confusion exists in the definition and application of leak tightness. That confusion is a result of improper leak-tightness design specifications. As product leakage is typically a microflow phenomenon, there are difficulties in applying relevant tools for testing, correlating, and analyzing leak tightness during product manufacturing and quality control.
By Brad Swarbrick, CAMO Software
Welcome to Multivariate Data Analysis For Dummies, your guide to the rapidly growing area of data mining and predictive analytics. Multivariate analysis is set to change the mindset of many industries and the way they approach the daunting task of analyzing large sets of data to extract the information they really need.