Pharmaceutical Technology, Jun 2, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, Jun 2, 2009
Online Exclusives
Donning by Design: Sterile Cleanroom Gowning Evolves
By Damon Larkin
A novel cleanroom apparel design incorporates modern concepts to help minimize contamination. Take a tour of the design.
FDA's Question-Based Review Initiative for Generic Drugs
The Question-Based Review (QbR) initiative of the Office of Generic Drugs has reached its second full year in 2009. Special from the Journal of Validation Technology.
Package Design Boosts Patient Compliance
By Hallie Forcinio
Compliance features help patients follow medication regimens correctly.
Quarantine at a Glance
By Joanna Anglin
A successful quarantine program requires collaboration among all departments of a pharmaceutical facility.
Quality in, Quality Out
By Sanjay Garg, PhD
A book guides readers through the regulatory requirements for computerized quality systems.
Special Report
Charting a Pathway to Follow-On Biologics
By Erik Greb
Debates about science, manufacturing, and European regulations will shape the approval process for follow-on biologics in the United States.
Drug Serialization and Supply-Chain Security
By Alexis Pellek
As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.
Peer-Reviewed Research
Initial Solvent Screening of Carbamazepine, Cimetidine, and Phenylbutazone: Part 2 of 2
By Tu Lee , Yan Chan Su , Hung Ju Hou , Hsiang Yu Hsieh
The authors describe the importance of a rapid and an abbreviated screening strategy in initial solvent screening. This article contains bonus online-exclusive material.
Pharmacosomes: A Potential Alternative to Conventional Vesicular Systems
By Sandeep Sangwan , Harish Dureja
Pharmacosomes can pass through biomembranes efficiently and possess several advantages over traditional vesicular drug-delivery systems.
Ingredients Insider
Outsourcing Clinical Trial Materials
By Patricia Van Arnum
CROs and CMOs expand to gain a piece of the market for clinical trial materials.
Outsourcing Outlook
Penny-Wise, Pound-Foolish
By Jim Miller
Pharma companies that sell redundant facilities could endanger their supply chains.
Washington Report
FDA Waves a Big Stick
By Jill Wechsler
Agency officials and manufacturers anticipate stricter enforcement of drug safety and quality.
Agent-In-Place
Operator Error
By Control, a senior compliance officer
Short-term problems in software or hardware lead to long-term manufacturing troubles.
From The Editor
Truth and Transparency
By Michelle Hoffman
Misleading the public about their investments—be it money or medicine—is unacceptable.
Viewpoint
Mapping Opportunities for Patent Positions
By Frances Weber , Scott D. Locke
Follow-on biologics could unleash the potential of several industries and may even spark economic recovery.
News
Report From: Ireland
By Sean Milmo
Despite its shrinking domestic economy, Ireland is determined not to let its pharmaceutical industry fade into the shadow of global recession.
Inside ICH
Inside ICH: Quality Trio Takes Final Shape
By John Smith , Christine Moore , Moheb Nasr
FDA leaders explain the purpose and plan for ICH's three quality guidelines.
PharmTech Talk
Beneath the Surface
By Maribel Rios
It can take a lot of work to make sure nothing happens.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for June 2009.

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
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