CONTENTS In this Issue 12 | RESEARCH
Technological Capabilities and Scientifi c Expertise Are Top Criteria in Pharmaceutical Outsourcing Selection, Survey Shows
Lea Studer, Vice President of Marketing Communications, SCORR Marketing
26 | COLD CHAIN
Potential Contribution of a Plasticized PVC Packaging Material to the Level of Elemental Impurities in Packaged Drug Products
Dennis Jenke, Barrett E. Rabinow, and Molly Chacko, Medical Products Division Baxter Healthcare Corporation
36 | API
Solubility in Pharmaceutical R&D: Predictions and Reality
David P. Elder, PhD* and Christoph Saal, PhD† *GlaxoSmithKline R&D, United Kingdom †
Merck KGaA, Germany
46 | INSIDER INSIGHT Today's Special in Clinical Trials: Risk-Based Monitoring. Have Investigators Been Served?
Eduardo F. Motti, MD, Trials & Training Consult
58 | HORIZON LINES A Quarterly Review of NDAs - 2Q14
Harshada Sant, MS and Hemant N. Joshi, PhD, MBA* Tara Innovations LLC
SPECIAL FEATURES 48 INTERPHEX 2015 PREVIEW
54 24TH ANNUAL PARTNERSHIPS IN CLINICAL TRIALS PREVIEW
REGULAR FEATURES 2 EDITOR'S MESSAGE 8 EDITORIAL ADVISORY BOARD
10 SOCIAL MEDIA CONNECTIONS
35 CN PERSPECTIVE 62 INDUSTRY NEWS 72 ADVERTISER’S INDEX
Integrity, Service & Dedication Ash Stevens has over 50 years of experience developing, registering and manufacturing Active Pharmaceutical Ingredients (APIs) for clients of all sizes, from Large Pharma to virtual startups. At our state-of-the-art cGMP facility in Michigan, we provide batch sizes from grams to hundreds of kilograms, including highly potent APIs (HPAPIs). We have a very successful track record moving projects forward to commercialization, achieving customer satisfaction through high quality science, regulatory excellence, safety and integrity.
Call our team +1 734 282 3370
www.ashstevens.com
Pharmaceutical Outsourcing | 6 | March/April 2015
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