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Pharmaceutical Technology-11-02-2009
Pharmaceutical Technology
Sharing Supply-Chain Security
November 02, 2009
Special Report
33
11
A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.
Facing Reality
November 02, 2009
Outsourcing Outlook
33
11
Contract organizations waiting for the pipeline to come roaring back are kidding themselves.
Changes for Better or Worse
November 02, 2009
Agent-In-Place
33
11
New tests solve one issue, but cheaper plastic and new stoppers cause problems.
Position Paper: Are We Abandoning IQ and OQ?
November 02, 2009
Online Exclusives
33
11
The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."
Safety versus Speed in Drug Development
November 02, 2009
Washington Report
33
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The heightened focus on risk raises concerns about delays in approving new drugs.
Insider Solutions: A New Direction for USP?
November 02, 2009
Insider Solutions
33
11
With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.
DIY Healthcare Reform
November 02, 2009
From The Editor
33
11
While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.
Are We Abandoning IQ and OQ?
November 02, 2009
Viewpoint
33
11
New standards may overlook critical qualification needs.
Advancing Chiral Chemistry in API Synthesis
November 02, 2009
Ingredients Insider
33
11
Functionalized supramolecular catalysts and an enantioselective route to unnatural amino acids are some recent developments.
Whatever Happened to Classical Chemistry?
November 02, 2009
Online Exclusives
33
11
A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.
A Robust, Automated Karl Fischer Titration System
November 02, 2009
Peer-Reviewed Research
33
11
The authors developed a robust, automated system to conduct Karl Fischer moisture assays for lyophilized products.
Q&A with Hans Engels, Business Unit President and CEO of DSM Pharmaceuticals
November 02, 2009
Industry Leaders: Q&A
33
11
Engels discusses the latest industry developments and trends.
Moisture-Activated Dry Granulation—Part I: A Guide to Excipient and Equipment Selection and Formulation Development
November 02, 2009
Peer-Reviewed Research
33
11
The authors explain a process for moisture-activated dry granulation in detail and provide guidance for the selection of excipients and equipment.
Stay Afloat with Lessons Learned
November 02, 2009
PharmTech Talk
33
11
FDA's Edwin Rivera-Martinez on dodging supply-chain challenges.
Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure
November 02, 2009
Position Papers
33
11
The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
In the Spotlight November 2009
November 02, 2009
In the Spotlight
33
11
Editors' Picks of Pharmaceutical Science & Technology Innovations
Report from: the Philippines
November 02, 2009
News
33
11
New pricing controls and healthcare reforms may be pushing the pharmaceutical market out of this southeast Asian country. This article contains bonus online-exclusive material.
Pharmaceutical Technology, November 2009 Issue (PDF)
November 01, 2009
Issue PDF
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Sharing Supply-Chain Security