Pharmaceutical Technology, Sep 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Sep 2, 2012
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Formulation Development Forum: Hydrogels for Long-Sustained Release
By Patricia Van Arnum
Researchers have developed injectable, reformable, and spreadable hydrogels capable of delivering sustained release of the proteins they contain for up to six months.
Special Report
Process Analytical Technology: Charting Progress in Data Analysis
By Patricia Van Arnum
Industry experts share perspectives on analytical instrumentation, methods, and data analysis.
Special Features
Future Innovation in Drug Delivery
By Patricia Van Arnum
Advances in targeted drug delivery and customized release profiles are key industry goals.
2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole
By Parenteral Drug Association
A review of taints and odors in the pharmaceutical and consumer healthcare industries.
Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product Deviations
By Reuben D. Domike , Jeffrey T. Macher , Paul W. Barone , Stacy L. Springs , Anthony J. Sinskey , Scott Stern
MIT survey results address product and site characteristics that statistically correlate with quality performance.
Peer-Reviewed Research
Peer Reviewed: Numerical Simulation of Tablet Coating
By Gregor Toschkoff , Daniele Suzzi , Siegfried Adam , Johannes G. Khinast
The authors investigate the tablet-coating process using a combination of different simulation techniques.
Position Papers
Early Development GMPs for Stability (Part IV)
By Bruce Acken , Mark Alasandro , Stephen Colgan , Paul Curry , Frank Diana , Q. Chan Li , Z. Jane Li , Tony Mazzeo , Andy Rignall , Z. Jessica Tan , Robert Timpano
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
Troubleshooting
Classifying Rouge Helps Define Remediation Procedures
By John Anderson
Identifying and classifying rouge can help to determine CAPA.
Guest Editorial
Joint Regulatory Conferences: The Ultimate Connection
By Richard Johnson
PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.
Inside USP
USP Further Strengthens Quality Standards for Heparin
By Anita Y. Szajek , Tina S. Morris
USP optimizes identification tests and impurities procedures.
In the Field
Report from Brazil
By Hellen Berger
Brazil takes first steps towards gaining quality requirements for pharmaceutical excipients.
Regulation and Compliance
Q&A on GDUFA implementation with Aloka Srinivasan, PhD, a principal consultant with Parexel and former team leader in FDA's Office of Generic Drugs.
PharmTech Talk
Europe Hones in on Antitrust Violations
By Stephanie Sutton
The European Commission remains vigilant in monitoring potential pay-to-delay deals.
Agent-in Place
Compliant or Contraband?
By Control, a senior compliance officer
International trade can be great for business, but breaking border laws can put one in hot water.
Regulatory Watch
Campaign Mounts to Curb Counterfeit Drugs
By Jill Wechsler
Import controls and risk strategies aim to promote quality and spur new drug development.
In the Spotlight
In the Spotlight
New product reviews for September 2012, featuring products for manufacturing.
Packaging Forum
Temperature-Controlled Shippers
By Hallie Forcinio
Packaging and monitoring tools protect temperature-sensitive pharmaceuticals.
Pharma Ingredients
Meeting Challenges in Asymmetric Synthesis
By Patricia Van Arnum
Industry and academia advance novel approaches for achieving enanioselectivity.
Outsourcing Outlook
The Macro View
By Jim Miller
The weak global economy adds to the challenges of bio/pharma companies and their suppliers.
Viewpoint
Technology Transfer: Protecting the True Public Interest
By Jim Greenwood
Ties between the biotechnology industry and university research are crucial.

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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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