Pharmaceutical Technology, Aug 1, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 1, 2008
Articles
Industry Outlook: Mixed Signals Lead to a New Outsourcing Equation
By Jim Miller
Survey results indicate a healthy market, but increasing competition.
The BRIC Countries: Opportunities for Regulated Market Players
By Kate Kuhrt
The author outlines the opportunities and challenges for manufacturers aiming to enter the BRIC-country markets.
Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply
By Balaji V. Kadri
To meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.
Outsourcing R&D in Asia: A Case Study of Pfizer
By Patricia Van Arnum
Gonghua Pan, associate director and head of the parallel medicinal chemistry sourcing operations at Pfizer, explains the evolution of the company's approach to outsourcing research and development from a line-or function-centric approach to an integrated sourcing model. This analysis includes the role that contract research organizations in Asia play in the company's outsourcing actvities.
Microdosing in Phase O: A Q&A with J. Scott Tarrant, Xceleron
By Patricia Van Arnum
J. Scott Tarrant, executive vice-president of Xceleron, explains the role of microdosing in drug development. He describes how microdose data can be used to predict pharmacological dose absorption, distribution, metabolism, and excretion/pharmacokinetic outcomes using accelerator mass spectrometry.
The Anatomy of the Changing Supply Chain
By Patricia Van Arnum
The high-profile case of contaminated heparin from a Chinese supplier has intensified the debate on the effectiveness of FDA's process for inspecting foreign drug-manufacturing facilities. The article examines proposed legislative and regulatory reforms and actions taken by the agency to improve drug-import safety.
Information-Technology Criteria in CMO Selection and Management
By Kathleen A. Pelley , John Postle
A sponsor company must investigate the manufacturing automation and systems, laboratory automation and systems, information-technology infrastructure, and business applications of each potential contract manufacturing organization.
Contract Service Providers: The State of the Market
By Michelle Hoffman
Outsourcing strategies of large pharma companies are changing. The CEO of Patheon talks about his company's plan to meet customers' changing needs.
Contract Vendors, They Are A Changin'
By Michelle Hoffman
As pharma companies outsource new types of projects, contractors are trying to meet new needs.

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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
22%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
11%
Regulatory compliance
37%
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 WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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