Pharmaceutical Technology, Aug 1, 2009 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Aug 1, 2009
Online Exclusives
Issue Extra: Executive Roundtable—The Future of Pharmaceutical CMC Outsourcing
By Jim Miller
A Q&A with Pfizer CentreSource, moderated by Jim Miller.
European Requirements for Pediatric Formulations
By Angie Drakulich
A summary of recent changes to European regulatory requirements for pediatric formulations.
Waivers and Deferrals Under the Pediatric Research Equity Act
By Kathryn Wekselman , William P. Stoltman , Peter Joiner
The authors explain waivers and deferrals for pediatric studies of drugs and biologics as provided by the Pediatric Research Equity Act of 2007.
Pharma Industry Consortium Rx-360 Tackles Supply-Chain Security
By Angie Drakulich
Industry is taking a step forward by addressing supply-chain integrity through the formation of Rx-360. PhamTech's podcast explores the subject.
Articles
Industry Outlook: Down But Not Out
By Jim Miller
The contract services industry may not be as robust in 2009 as it has been in previous years, but it's not as bad as many people think.
Growing Pains
By Michelle Hoffman
As the pharmaceutical supply chain expands, sponsor companies need to weigh all their options.
The Future of Pharmaceutical CMC Outsourcing
By Jim Miller
A roundtable with pharma majors Pfizer and Johnson & Johnson, moderated by Jim Miller.
Global Outsourcing: A Roundtable of Contract Manufacturers
By Patricia Van Arnum
Leading contract manufacturing organizations share their views on the current and future market dynamics shaping pharmaceutical outsourcing.
Outsourcing Stability Studies
By David C. Browne
The author provides advice about evaluating contract analytical laboratories and establishing an effective procedure for working with them to perform reliable stability studies.
Pediatric Formulations: Technical and Regulatory Considerations
By Patricia Van Arnum
Leading experts share their perspective on the specialized requirments when developing a pediatric formulation and examine dosage forms that can be used for this patient class in this roundtable moderated by Patricia Van Arnum.
Industry Resources
Fast Locator Index: North America
Fast Locator Index for North America, from PharmTech's Guide to Conventional and Biotech Pharmaceutical Outsourcing Services.
Fast Locator Index: Europe and Asia
Fast Locator Index for Europe and Asia, from PharmTech's Guide to Conventional and Biotech Pharmaceutical Outsourcing Services.
Fast Locator Index: API Production Technologies
Fast Locator Index for API Production Technologies, from PharmTech's Guide to Conventional and Biotech Pharmaceutical Outsourcing Services.

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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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