Pharmaceutical Technology, Apr 2, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, Apr 2, 2009
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Ever Vigilant (A Pharmacovigilance Book Review)
By Todd L. Cecil
In a recent book, UK regulators explain how to establish a pharmacovigilance system.
Downpayment on Health Reform
By Jill Wechsler
President Obama's economic recovery plain includes goals such as reducing the number of uninsured citizens and improving the quality of healthcare.
Special Report
Deep Freeze: Innovations in Lyophilization
By Maribel Rios
By reducing cycle time and implementing quality-by-design inspired engineering, advanced lyophilization systems are driving the industry toward greater efficiency and control.
Peer-Reviewed Research
Reference-Standard Material Qualification
By David C. Browne
The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program.
Silicone Microdroplets in Protein Formulations—Detection and Enumeration
By Deepak K. Sharma , Peter Oma , Sampath Krishnan
The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.
The Value of In Vitro Dissolution in Drug Development
By Cheng Tong , Ruben Lozano , Yun Mao , Tahseen Mirza , Raimar Löbenberg , Beverly Nickerson , Vivian Gray , Qingxi Wang
A Position Paper from the AAPS In Vitro Release and Dissolution Focus Group
Ingredients Insider
Tracking Excipients
By Patricia Van Arnum
A review of recent product innovations, policy developments, and growth prospects in the excipients market.
Outsourcing Outlook
Contract Organizations are the Sell of the Season
By Jim Miller
Despite the market downturn, private equity investors are lining up for pharmaceutical services.
Insider Solutions
Insider Solutions: Device Database Can Help Pharma
By Susan J. Schniepp
Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.
Washington Report
Congress and Obama Seek to Bolster Drug Safety
By Jill Wechsler
FDA is poised to gain authority and resources to ensure the quality of food and drugs.
From The Editor
Parallel Tracks
By Michelle Hoffman
Obama's cost-containment and science-innovation initiatives need to overlap.
Agent-In-Place
Out of Control
By Control, a senior compliance officer
GMP agents report on old products, aseptic violations, and unexpected emotions.
Viewpoint
Automation Vendor or Partner?
By Bob Lenich , Joanne Salazar
The role of automation suppliers is transforming to meet the pharma industry's demand for change.
News
Report from: Europe
By Sean Milmo
Although industry is tightening its belt, contract manufacturers across Europe are actually making out quite well by taking on additional projects and new roles.
PharmTech Talk
Moving Toward a Drug Development Boon or Bust?
By Patricia Van Arnum
The financial and economic downturn is likey to have long-term implications for outsourcing.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for April 2009.

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
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