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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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