Pharmaceutical Technology, Jul 2, 2013 - Pharmaceutical Technology

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Pharmaceutical Technology, Jul 2, 2013
Cover Story
Controlling Drug Release Through Osmotic Systems
By Adeline Siew, PhD
Osmotic systems offer versatility for delivering drugs with varied properties and dosage requirements.
Special Features
Strengthening the Supply Chain for Pharmaceutical Ingredients
By Patricia Van Arnum
The US and EU move forward with measures to fortify the pharmaceutical supply chain.
API Synthesis & Manufacturing
Gauging Investment in High-Potency Manufacturing
By Patricia Van Arnum
Contract service providers expand capabilities in API and finished product manufacturing to meet demand for high-potency drugs.
Peer-Reviewed Research
Evaluating Risk-Based Specifications for Pharmaceuticals
By Chris Burgess
The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.
Regulation & Compliance
FDA Urges Greater Focus on Contractor Quality
By Jill Wechsler
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
EU Battles Medicine Shortages
By Sean Milmo
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
Regulatory Roundup
By Jill Wechsler
Compounding, tracking legislation moves forward
Inside USP
USP Partners Globally for 21st-Century Medicines
By V. Srini Srinivasan
USP focuses on building worldwide partnerships in standards-setting activities.
Troubleshooting
Evaluating Parenteral Packaging for Glass Delamination
By Daniel Haines
A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.
Global Feature
Report from Brazil
By Hellen Berger
Brazil offers opportunities and challenges for global pharmaceutical companies.
BioForum
Extractables and Leachables: Best Practices to Ensure Patient Safety
By Thomas Feinberg, PhD
The author presents best practices for extractables and leachables.
Outsourcing Outlook
What Happened to Outsourcing in Asia?
By Eric Langer
The industry may not be ready for India and China as regulatory issues emerge.
Ask the Expert
Navigating FDA Regulatory Meetings
David Elder, vice-president, technical at PAREXEL, discusses the best way to productively participate in a regulatory meeting with FDA.
From The Editor
The Pains of Change
By Rita Peters
Pharma and biotech companies, with the rest of the health care industry, must face change.
Industry Leaders
Q&A with Claudia Roth, President, Vetter Development Service, USA
Claudia Roth, President of Vetter Development Service USA, discusses trends in single-use technology for clinical manufacturing.
In the Spotlight
Editors' picks of pharmaceutical science & technology innovations
Editors' picks of pharmaceutical science & technology innovations; the latest in automation/IT/process control from Invensys Operations Management, Novatek International, Aspen Technology, and Accelrys.

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Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
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View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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