PTSM: Pharmaceutical Technology Sourcing and Management, Dec 5, 2007 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

PTSM: Pharmaceutical Technology Sourcing and Management, Dec 5, 2007
Global Feature
A FDA Perspective on Quality by Design
By Patricia Van Arnum
Chi-wan Chen, deputy director of the Office of New Drug Quality Assessment (ONDQA) at the US Food and Drug Administration's Center for Drug Evaluation and Research, shares insight from FDA's pilot program that was designed to allow pharmaceutical companies to submit CMC information demonstrating application of quality by design.
APIs
2007 Ends with a Drought in New Molecular Entities
By Patricia Van Arnum
The number of new molecular entities approved by the US Food and Drug Administration is down this year as the pharmaeutical industry continues to face an innovation drought.
Mergers, acquisitions, and restructuring
2007: The Year in Review
By Patricia Van Arnum
Big Pharma's strategic push into biologics and continuing restructuring are among the highlights for 2007.
Outsourcing
Mixed Message for Contract Manufacturers
By Jim Miller
Candid comments from a Big Pharma executive highlight the complexity of contract manufacturing.

ADVERTISEMENT

LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Click here