Pharmaceutical Technology, Feb 2, 2013 - Pharmaceutical Technology

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Pharmaceutical Technology, Feb 2, 2013
Cover Story
Seeking Cold Chain Efficiency
By Hallie Forcinio
Medication safety and efficacy depend on maintaining products at the proper temperature.
Guest Editorial
Offering a Pharma View of Social Media
By Aaron Davidson
Why social media presents unique challenges and opportunities for pharmaceutical companies.
News
Pharma Conversation & Community
By Stephanie Sutton
A round up of news from across the web, including trends from social social media platforms.
Product Spotlight
The Latest in Tableting and Granulation
New product reviews for February 2013.
BioForum
Tracking Growth in Biologics
By Patricia Van Arnum
The share of biologic-based drugs in the global pharmaceutical market is on the rise.
Regulation & Compliance
Regulatory Roundup
A roundup of regulatory news from across the global pharmaceutical industry.
GMP Compliance Becomes Prominent Enforcement Issue
By Jill Wechsler
Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.
Inside USP
Modernization of USP Standards
By Anthony DeStefano
The US Pharmacopeial Convention contiues to make modernization of standards a top priority in 2013.
Insider Solutions
The Human Error Behind Human Error
By Susan J. Schniepp
A thorough investigation of all possible causes of deviations should be performed.
CMC Troubleshooting
Rouge Contaminants and Water Systems
Measuring the rouge corrosion rate can help determine when a system should be cleaned so the final product is not impacted
Global Feature
Report from India
By Jane Wan
Quality assurance of biological products is central to India's good distribution practices guidelines.
Navigating Emerging Markets — Eastern Europe
Eastern Europe is moving towards a goal of harmonized regulations.
Troubleshooting
Solving Tableting and Tooling Problems
By Trevor Higgins
Adopting a seven-step process to maintenance and storage improves tableting quality.
API Synthesis & Manufacturing
Gaining Stereoselectivity in Asymmetric Synthesis
By Patricia Van Arnum
Researchers use inorganic catalysts as an alternative to biocatalysts in the selective conversion of sugars to produce chiral building blocks.
Peer-Reviewed Research
Improving Inhaled Product Testing: Methods for Obtaining Better In vitro-In vivo Relationships
By Mark Copley
Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.
Determination of Surface Visible Residue Limits on Pharmaceutical Plant Equipment
By David Ian Fletcher
The minimum amount of residue that can be visually detected is demonstrated for a small number of active pharmaceutical ingredients (APIs) on a range of different surface materials.
Position Paper
Modernization of the Standards for Elemental Impurities
By Jon E. Clark , John S. Punzi
Recent activity in standards-setting organizations has raised interest in the impact of testing for impurities that may enter the product before it is mined or harvested or even due to intentional use of some reagents.
Statistical Solutions
Calculating the Reportable Result from Retest Data
By Chris Burgess
Two methods to evaluate retest data following out-of-specification results.
Outsourcing Outlook
End of the Dedicated CMO?
By Jim Miller
Is the contract-only CMO an endangered species?
Ask the Expert
The EU's Falsified Medicines Directive and APIs
Siegfried Schmitt, a principal consultant with PAREXEL, discusses how the EU's Falsified Medicines Directive will affect US API production.
Industry Leaders
Q&A With Chris Ecles
PharmTech speaks to Chris Eccles, managing director of ChargePoint Technology.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
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Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
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