Pharmaceutical Technology, Feb 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Feb 2, 2012
Special Reports
An Enhanced Approach to Drug-Substance Development and Manufacture
By Angie Drakulich
FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.
Optimizing Adjuvant Filtration: A Technical Forum
Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.
Peer-Reviewed Research
Evaluating Impurities in Drugs (Part I of III)
By Kashyap R. Wadekar , Mitali Bhalme , S. Srinivasa Rao , K. Vigneshwar Reddy , L. Sampath Kumar , E. Balasubrahmanyam
In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products.
From The Editor
Sustainable Investment
By Angie Drakulich
Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.
Inside ICH
Inside ICH: ICH Implementation Support
By Stephan Rönninger , Sabine Scheitlin
ICH Q8, Q9, and Q10 support and implications for the future.
In the Field
Report from India
By A. Nair
The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports.
PharmTech Talk
FDA's Social Media Insight
By Stephanie Sutton
Guidance offered on how to deal with off-label information requests.
Agent-in Place
Shipping with the Enemy?
By Control, a senior compliance officer
A nickel's worth of free advice to the competition could come at the expense of your bottom line.
Washington Report
FDA and Justice Department Address Drug Quality Concerns
By Jill Wechsler
More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.
In the Spotlight
In the Spotlight
New product reviews for February 2012.
BioForum
Single-Use High Capacity Membrane Chromatography
By Carl Lawton
Debottlenecking downstream mAb purification.
Pharma Ingredients
Expanding Capabilities in the Pharmaceutical Cold Chain
By Patricia Van Arnum
As biopharmaceutical development and commercialization increases, companies are expanding their cold-chain capabilities.
Formulation Development Forum: Boronate Cross-linked Micelles
By Patricia Van Arnum
A new class of nanoparticles hold promise for preventing premature drug release and offering greater accuracy and effectiveness in drug delivery.
Statistical Solutions
Reducing Common Cause Variation
By Lynn D. Torbeck
Where is the variability coming from and what have we done to minimize it?
Outsourcing Outlook
Biomanufacturing Outlook
By Eric Langer
Industry optimism is on the rise for 2012.
Viewpoint
Saving the Next Generation of Regulatory Scientists
By Frances J. Richmond
New educational programs are key to the industry's future and to safe, available drugs.

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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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