Pharmaceutical Technology-09-02-2012

Pharmaceutical Technology

Pharmaceutical Technology, September 2012 Issue (PDF)

September 02, 2012

Issue PDF

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Process Analytical Technology

Formulation Development Forum: Hydrogels for Long-Sustained Release

September 02, 2012

Online Exclusive

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Researchers have developed injectable, reformable, and spreadable hydrogels capable of delivering sustained release of the proteins they contain for up to six months.

Regulation and Compliance

September 02, 2012

In the Field

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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.

2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole

September 02, 2012

Special Features

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A review of taints and odors in the pharmaceutical and consumer healthcare industries.

Early Development GMPs for Stability (Part IV)

September 02, 2012

Position Papers

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IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.

Joint Regulatory Conferences: The Ultimate Connection

September 02, 2012

Guest Editorial

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PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.

Future Innovation in Drug Delivery

September 02, 2012

Special Features

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Advances in targeted drug delivery and customized release profiles are key industry goals.

Temperature-Controlled Shippers

September 02, 2012

Packaging Forum

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Packaging and monitoring tools protect temperature-sensitive pharmaceuticals.

Technology Transfer: Protecting the True Public Interest

September 02, 2012

Viewpoint

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Ties between the biotechnology industry and university research are crucial.

Europe Hones in on Antitrust Violations

September 02, 2012

PharmTech Talk

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The European Commission remains vigilant in monitoring potential pay-to-delay deals.

Compliant or Contraband?

September 02, 2012

Agent-in Place

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International trade can be great for business, but breaking border laws can put one in hot water.

Process Analytical Technology: Charting Progress in Data Analysis

September 02, 2012

Special Report

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Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

Meeting Challenges in Asymmetric Synthesis

September 02, 2012

Pharma Ingredients

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Industry and academia advance novel approaches for achieving enanioselectivity.

In the Spotlight September 2012

September 02, 2012

In the Spotlight

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New product reviews for September 2012, featuring products for manufacturing.

The Macro View

September 02, 2012

Outsourcing Outlook

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The weak global economy adds to the challenges of bio/pharma companies and their suppliers.

Classifying Rouge Helps Define Remediation Procedures

September 02, 2012

Troubleshooting

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Identifying and classifying rouge can help to determine CAPA.

USP Further Strengthens Quality Standards for Heparin

September 02, 2012

Inside USP

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USP optimizes identification tests and impurities procedures.

Campaign Mounts to Curb Counterfeit Drugs

September 02, 2012

Regulatory Watch

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Import controls and risk strategies aim to promote quality and spur new drug development.

Report from Brazil September 2012

September 02, 2012

In the Field

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Brazil takes first steps towards gaining quality requirements for pharmaceutical excipients.

Correlating Product Lifecycle and Manufacturing Site Characteristics with Critical-to-Quality Product Deviations

September 02, 2012

Special Features

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MIT survey results address product and site characteristics that statistically correlate with quality performance.

Peer Reviewed: Numerical Simulation of Tablet Coating

September 02, 2012

Peer-Reviewed Research

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The authors investigate the tablet-coating process using a combination of different simulation techniques.