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

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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.

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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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