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Pharmaceutical Technology-07-02-2013
Pharmaceutical Technology
Regulatory Roundup
July 02, 2013
Regulation & Compliance
37
7
Compounding, tracking legislation moves forward
Evaluating Risk-Based Specifications for Pharmaceuticals
July 02, 2013
Peer-Reviewed Research
37
7
The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.
Controlling Drug Release Through Osmotic Systems
July 02, 2013
Cover Story
37
7
Osmotic systems offer versatility for delivering drugs with varied properties and dosage requirements.
Q&A with Claudia Roth, President, Vetter Development Service, USA
July 02, 2013
Industry Leaders
37
7
Claudia Roth, President of Vetter Development Service USA, discusses trends in single-use technology for clinical manufacturing.
Report from Brazil July 2013
July 02, 2013
Global Feature
37
7
Brazil offers opportunities and challenges for global pharmaceutical companies.
Editors' picks of pharmaceutical science & technology innovations
July 02, 2013
In the Spotlight
37
7
Editors' picks of pharmaceutical science & technology innovations; the latest in automation/IT/process control from Invensys Operations Management, Novatek International, Aspen Technology, and Accelrys.
Evaluating Parenteral Packaging for Glass Delamination
July 02, 2013
Troubleshooting
37
7
A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.
Navigating FDA Regulatory Meetings
July 02, 2013
Ask the Expert
37
7
David Elder, vice-president, technical at PAREXEL, discusses the best way to productively participate in a regulatory meeting with FDA.
EU Battles Medicine Shortages
July 02, 2013
Regulation & Compliance
37
7
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
USP Partners Globally for 21st-Century Medicines
July 02, 2013
Inside USP
37
7
USP focuses on building worldwide partnerships in standards-setting activities.
Gauging Investment in High-Potency Manufacturing
July 02, 2013
API Synthesis & Manufacturing
37
7
Contract service providers expand capabilities in API and finished product manufacturing to meet demand for high-potency drugs.
What Happened to Outsourcing in Asia?
July 02, 2013
Outsourcing Outlook
37
7
The industry may not be ready for India and China as regulatory issues emerge.
FDA Urges Greater Focus on Contractor Quality
July 02, 2013
Regulation & Compliance
37
7
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
Extractables and Leachables: Best Practices to Ensure Patient Safety
July 02, 2013
BioForum
37
7
The author presents best practices for extractables and leachables.
Strengthening the Supply Chain for Pharmaceutical Ingredients
July 02, 2013
Special Features
37
7
The US and EU move forward with measures to fortify the pharmaceutical supply chain.
The Pains of Change
July 02, 2013
From The Editor
37
7
Pharma and biotech companies, with the rest of the health care industry, must face change.
Pharmaceutical Technology, July 2013 Issue (PDF)
July 02, 2013
Issue PDF
37
7
Click the title above to open the Pharmaceutical Technology July 2013 issue in an interactive PDF format.