Pharmaceutical Technology, Sep 2, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, Sep 2, 2009
Online Exclusives
A Green Manufacturing Route to Testosterone
By Bill Kovats , Kenneth Ball
A second-generation and green manufacturing process for testosterone provided economic and ecological benefits.
Drug Master Files: Requirements and Challenges
By Thomas Warden
The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates.
It's Easy Being Green
By Charles A. Eckert
An outstanding new book reviews alternative solvents with an eye to sustainable pharmaceutical processes.
Special Report
Robots: The Next Phase in Pharmaceutical Automation
By Erik Greb , Maribel Rios
Robotic systems provide flexibility and efficiency (and they're not as difficult to use as you think). This article contains bonus online-exclusive material.
Green API Manufacturing
By Liam Tully
Pfizer uses green-chemistry in a second-generation manufacturing route for gabapentin.
Peer-Reviewed Research
Evaluating Functional Equivalency as a Lyophilization Cycle Transfer Tool
By Amol Mungikar , Miron Ludzinski , Madhav Kamat
The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.
Ingredients Insider
Tracking CMO Activity
By Patricia Van Arnum
Select contract manufacturing organizations roll out expansions for production of active pharmaceutical ingredients and intermediates.
Outsourcing Outlook
Expansion Plan
By Jim Miller
Contract-service providers are expanding their offerings in this slow-growth environment.
Washington Report
Global Health Concerns Create Business Opportunities
By Jill Wechsler
Health crises generate support for new vaccines and treatments for diseases found in developing nations.
Inside ICH
Inside ICH–MHLW: Working Groups Ramp up Quality-based Implementation
By Tsuyoshi Ando , Yukio Hiyama , Yoshihiro Matsuda , Tamiji Nakanishi , Haruhiro Okuda
Representatives of Japan's MHLW report on recent ICH activities and what the ministry expects from Q11.
Inside IPEC
Inside IPEC–Americas: Evaluating Excipient Stability
By Philip H. Merrell , Irwin Silverstein, PhD
IPEC's new stability testing guide takes into account the full supply chain's storage conditions.
Agent-In-Place
Of Audits and Gunk
By Control, a senior compliance officer
Thanks to their keen observations, these auditors reveal the true culprits of deviations.
Packaging Forum
Pill-Level Product Protection
By Hallie Forcinio
Authenticating tools help identify counterfeit drug products. This article contains bonus online-exclusive material.
From The Editor
Quality by Enforcement
By Michelle Hoffman
After years of promomting QbD concepts, FDA's ready to take action on nonconformers.
Viewpoint
A Brave New Path for Pharma
By Anthony Farino
Personalized medicine and integrated healthcare delivery require new business and pricing models. This article contains bonus online-exclusive material.
Industry Leaders: Q&A
Timothy Oostdyk of Lancaster Labs
Oostdyk discusses the latest industry developments and trends.
News
Report From: Brazil
By Marcelo Sicoli
Designated as a "pharmerging market," Brazil is revamping its pricing models.
PharmTech Talk
The Go/No-Go Mindset
By Angie Drakulich
As new process validation guidelines emerge, industry needs to reinvent how it releases product.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for September 2009.

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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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