Pharmaceutical Technology, September 2009 Issue (PDF)
Robots Lend a Hand
Pharma Capsules
Brief pharmaceutical news items for September 2009.
Q&A with Timothy Oostdyk, Executive Vice-President and Chief Operating Officer of Lancaster Laboratores
Oostdyk discusses the latest industry developments and trends.
Of Audits and Gunk
Thanks to their keen observations, these auditors reveal the true culprits of deviations.
Quality by Enforcement
After years of promomting QbD concepts, FDA's ready to take action on nonconformers.
Robots: The Next Phase in Pharmaceutical Automation
Robotic systems provide flexibility and efficiency (and they're not as difficult to use as you think). This article contains bonus online-exclusive material.
It's Easy Being Green
An outstanding new book reviews alternative solvents with an eye to sustainable pharmaceutical processes.
Expansion Plan
Contract-service providers are expanding their offerings in this slow-growth environment.
A Green Manufacturing Route to Testosterone
A second-generation and green manufacturing process for testosterone provided economic and ecological benefits.
In the Spotlight September 2009
Editors' Picks of Pharmaceutical Science & Technology Innovations
Pill-Level Product Protection
Authenticating tools help identify counterfeit drug products. This article contains bonus online-exclusive material.
A Brave New Path for Pharma
Personalized medicine and integrated healthcare delivery require new business and pricing models. This article contains bonus online-exclusive material.
Tracking CMO Activity
Select contract manufacturing organizations roll out expansions for production of active pharmaceutical ingredients and intermediates.
Global Health Concerns Create Business Opportunities
Health crises generate support for new vaccines and treatments for diseases found in developing nations.
Inside ICH–MHLW: Working Groups Ramp up Quality-based Implementation
Representatives of Japan's MHLW report on recent ICH activities and what the ministry expects from Q11.
Green API Manufacturing
Pfizer uses green-chemistry in a second-generation manufacturing route for gabapentin.
Evaluating Functional Equivalency as a Lyophilization Cycle Transfer Tool
The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.
The Go/No-Go Mindset
As new process validation guidelines emerge, industry needs to reinvent how it releases product.
Inside IPEC–Americas: Evaluating Excipient Stability
IPEC's new stability testing guide takes into account the full supply chain's storage conditions.
Drug Master Files: Requirements and Challenges
The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates.
Report From: Brazil
Designated as a "pharmerging market," Brazil is revamping its pricing models.
