Pharmaceutical Technology, May 2, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, May 2, 2008
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Florida Builds its Position in the Life Sciences
By Patricia Van Arnum
Florida is making its case for pharmaceutical and biotechnology research and development.
Dissolving the Insoluble
By Larry L. Augsburger, PhD
An authoritative book helps drug developers face one of their toughest problems.
Special Report
Unplugged: Developing Standards for Wireless Automation
By Maribel Rios
ISA 100.11a and WirelessHART both seek to become the global standard for industrial wireless automation.
Peer-Reviewed Research
FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based Approach
By Representatives of the US Food and Drug Administration and Industry
The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.
Approved Applications of Dimethyl Sulfoxide USP, PhEur
By A.S. McKim , Robert Strub
The authors survey the approved applications of dimethyl sulfoxide USP, PhEur across the healthcare industry and consider the suitability of DMSO from a regulatory and formulation compatibility standpoint.
EPCAM: Enabling Manufacturing-Process Control Transformation
By James M. Prendergast , Michael Passow , Michael T. Ricci , Srinivas S. Dagalur , Dennis Bell , Limuel Sagadraca
Enterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
Washington Report
Attacks on FDA Escalate
By Jill Wechsler
Regulators face demands to improve postmarket surveillance and meet review deadlines.
Outsourcing Outlook
CMOs are Planning for the Last War
By Jim Miller
CMO business models are out of touch with current pharma industry realities. It's time for new thinking.
Agent-In-Place
Troubled Waters
By Control, a senior compliance officer
WFI system deficiencies and damp tax records cause problems for two plants
Ingredients Insider
Unfolding Catalytic Routes to APIs
By Patricia Van Arnum
Chemocatalytic and biocatalytic routes show promise for more efficient syntheses of select active ingredients.
Viewpoint
Converging InformationTechnology & Automation Teams
By Julie Fraser , Matt Bauer
Getting IT, engineering, and manufacturing on the same page requires a delicate balance.
Inside IPEC
Inside IPEC–Americas: Excipient Audits and API Audits are Worlds Apart
By Irwin Silverstein, PhD
The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.
From The Editor
Requiem for a Vaccine
By Michelle Hoffman
Scientists are giving up on a preventive vaccine for AIDS, but there are lessons to be learned.
PharmTech Talk
PharmTech Talk
By Erik Greb
INTERPHEX 2008 offered visitors novel experiences and many stimulating sessions.
News
Report from Europe
By Sean Milmo
With counterfeiting on the rise and Europeans worried their backyard is becoming a base for such illegal activity, legislators have proposed a series of solutions that span the continent and abroad.
Market Watch: Japan
By Angie Drakulich
According to the latest figures from IMS Health, Inc., Japan's pharmaceutical market is expected to grow 1–2% this year compared to global industry growth expectations of 5–6%.
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for May 2008.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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Expedited reviews of drug submissions
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Reducing drug shortages
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Breakthrough designations
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Protecting the supply chain
17%
Expedited reviews of drug submissions
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More stakeholder involvement
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View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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