Pharmaceutical Technology, Nov 2, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, Nov 2, 2009
Online Exclusives
Position Paper: Are We Abandoning IQ and OQ?
By Louis A. Angelucci
The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of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."
Whatever Happened to Classical Chemistry?
By David Vetterlein
A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.
Special Report
Sharing Supply-Chain Security
By Angie Drakulich
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.
Peer-Reviewed Research
A Robust, Automated Karl Fischer Titration System
By Philippe Lam , Mike Nariman
The authors developed a robust, automated system to conduct Karl Fischer moisture assays for lyophilized products.
Moisture-Activated Dry Granulation—Part I: A Guide to Excipient and Equipment Selection and Formulation Development
By Ismat Ullah , Jennifer Wang , Shih-Ying Chang , Gary J. Wiley , Nemichand B. Jain , San Kiang
The authors explain a process for moisture-activated dry granulation in detail and provide guidance for the selection of excipients and equipment.
Ingredients Insider
Advancing Chiral Chemistry in API Synthesis
By Patricia Van Arnum
Functionalized supramolecular catalysts and an enantioselective route to unnatural amino acids are some recent developments.
Outsourcing Outlook
Facing Reality
By Jim Miller
Contract organizations waiting for the pipeline to come roaring back are kidding themselves.
Insider Solutions
Insider Solutions: A New Direction for USP?
By Susan J. Schniepp
With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.
Washington Report
Safety versus Speed in Drug Development
By Jill Wechsler
The heightened focus on risk raises concerns about delays in approving new drugs.
Agent-In-Place
Changes for Better or Worse
By Control, a senior compliance officer
New tests solve one issue, but cheaper plastic and new stoppers cause problems.
Position Papers
Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure
By Christopher C. DeMerlis , Jay M. Goldring , Ranga Velagaleti, PhD , William Brock , Robert Osterberg
The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
From The Editor
DIY Healthcare Reform
By Michelle Hoffman
While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.
PharmTech Talk
Stay Afloat with Lessons Learned
By Angie Drakulich
FDA's Edwin Rivera-Martinez on dodging supply-chain challenges.
Viewpoint
Are We Abandoning IQ and OQ?
By Louis A. Angelucci
New standards may overlook critical qualification needs.
News
Report from: the Philippines
By Jane Wan
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.
Industry Leaders: Q&A
Hans Engels of DSM Pharmaceuticals
Engels discusses the latest industry developments and trends.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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