Pharmaceutical Technology-08-01-2008

Pharmaceutical Technology

Microdosing in Phase O: A Q&A with J. Scott Tarrant, Xceleron

August 01, 2008

Articles

2008 Supplement

3

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.

Outsourcing R&D in Asia: A Case Study of Pfizer

August 01, 2008

Articles

2008 Supplement

3

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.

Information-Technology Criteria in CMO Selection and Management

August 01, 2008

Articles

2008 Supplement

3

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.

The Anatomy of the Changing Supply Chain

August 01, 2008

Articles

2008 Supplement

3

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.