Pharmaceutical Technology, Jun 2, 2010 - Pharmaceutical Technology

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Pharmaceutical Technology, Jun 2, 2010
Online Exclusives
Biopharmaceutical Form and Function
By Sanjay Garg, PhD
A timely new book explains techniques for conformational analysis.
Puerto Rico Builds a Foundation for Biopharmaceuticals
By Patricia Van Arnum
Puerto Rico, long a mainstay of solid-dosage manufacturing, intensifies efforts in biopharmaceutical manufacturing and research and development.
Special Report
Excipients Step into the Spotlight
By Angie Drakulich
Industry and regulatory experts discuss excipient testing, regulatory expectations, supply-chain challenges, and pricing in this Speakers Roundtable. This article contains bonus online material and podcasts.
Ingredients Insider
Outsourcing Clinical Trial Development and Materials
By Patricia Van Arnum
CROs and CMOs adapt their business models and capabilities to meet sponsor companies' need to reduce costs and accelerate development time.
Peer-Reviewed
A Risk-Management Approach to Cleaning-Assay Validation
By Brian W. Pack , Jeffrey D. Hofer
The authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study.
From The Editor
Anniversary Season
By Michelle Hoffman
The birth of "the pill" and harmonization created a new paradigm for global standards.
PharmTech Talk
Making a Difference
By Patricia Van Arnum
A PharmTech forum to discuss the industry's efforts in corporate social responsibility and sustainability.
Agent-in Place
Everybody's Got Problems
By Control, a senior compliance officer
Too much or too little control can actually lead to the same result.
In the Spotlight
In the Spotlight
Editors' picks of pharmaceutical science and technology innovations.
News
Report from Europe
By Sean Milmo
Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.
Washington Report
Securing the Supply Chain
By Jill Wechsler
FDA and industry seek to ensure drug quality and safety in a world complicated by global outsourcing and rising theft.
Packaging Forum
Even Packaging Can Multitask
By Hallie Forcinio
Interphex attendees found packaging machines and containers with increased functionality. This article contains online bonus material.
Inside USP
Inside USP: Positioned for Growth
By Roger L. Williams
USP membership meeting prepared the standards-setting body to meet modern challenges.
Outsourcing Outlook
EU Debt Crisis Adds Uncertainty
By Jim Miller
The sovereign debt crisis in the EU could greatly change the landscape for contract services.
Industry Leaders: Q&A
A Q&A with Uwe Ross of Binder
The president of Binder, a manufacturer of simulation chambers, addresses the consolidation of Big Pharma, and more.
Viewpoint
Leveling the Compliance Playing Field
By Paul Larocque
The author suggests industry may need a NATO-type organization to even out inspections.

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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
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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