Pharmaceutical Technology, Sep 2, 2010 - Pharmaceutical Technology

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Pharmaceutical Technology, Sep 2, 2010
Online Exclusives
Inside USP: Modernizing the Compendia
By Karen A. Russo
Industry participation is crucial as USP embarks on far-reaching monograph modernization initiative. This is an online-exclusive article.
Strategic Approaches to Process Optimization and Scale-up
By Conor P. Long , John McQuaid
The authors present three approaches that a contract development and manufacturing organization can consider when designing development and process-optimization studies that will provide useful data for scaling up a project.
Special Report
Going Digital
By Erik Greb
Software and online monitoring are helping the pharmaceutical industry improve its corrective and preventive action programs. This article contains bonus online material.
Authentication and Pharmaceutical Protection: An Industry Roundtable
By Alexis Pellek
PharmTech talked to anticounterfeiting experts to discuss terrorism as a source of counterfeit products.
Ingredients Insider
Technical Forum: Small-Molecule Synthesis
By Patricia Van Arnum
Pharmaceutical Technology gains insight into approaches for producing aromatic amines.
Peer-Reviewed
Statistical Considerations in Design Space Development (Part III of III)
By Stan Altan , James Bergum , Lori Pfahler , Edith Senderak , Shanthi Sethuraman , Kim Erland Vukovinsky
In the final article of a three-part series, the authors discuss how to present a design space and evaluate its graphical representation.
From The Editor
Survey Says...
By Michelle Hoffman
New data provide insight into pharma-industry professionals' daily lives.
Statistical Solutions
Statistical Solutions: Visual Inspection Goes Viral
By Lynn D. Torbeck
To properly inspect based on measurement, a reference standard is crucial for comparison.
PharmTech Talk
Above and Beyond
By Angie Drakulich
Industry efforts toward global healthcare surpass average expectations.
Agent-in Place
No More Exceptions
By Control
From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.
In the Spotlight
In the Spotlight
Editors' picks of pharmaceutical science and technology innovations.
News
Report from Brazil
By Hellen Berger
A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.
Washington Report
FDA Struggles with Risk Management and Drug Safety
By Jill Wechsler
Weighing the pros and cons of REMS for bringing risky products to market.
Outsourcing Outlook
R&D Mash-ups
By Jim Miller
Changing demands in drug development lead to new service combinations and models.
Industry Leaders
Q&A with Diteba's Theo Kapanadze
The executive vice-president of sciences discusses industry trends and challenges.
Viewpoint
Congress Attempts to Fix a System that Isn't Broken
By Kevin D. McDonald
Pending legislation may give FTC the authority to regulate all Hatch-Waxman settlements.

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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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