Pharmaceutical Technology, May 2, 2010 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, May 2, 2010
Online Exclusives
Validation by Numbers
By Russell E. Madsen Jr.
A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.
Special Report
Thinking Inside the Box
By Erik Greb
A modular approach to biopharmaceutical production could bring process flexibility, and contract manufacturing organizations are beginning to take notice.
Ingredients Insider
Exploring Catalysis in API Synthesis
By Patricia Van Arnum
Chemocatalysis and biocatalysis are important elements of an effective strategy for improving yield and stereoselectivty.
Peer-Reviewed Research
Skin Permeation of Rosiglitazone from Transdermal Matrix Patches
By N. Damodharan , Gopa Roy , Soma Ghosh , Biswajit Mukherjee, PhD
The authors demonstrate that sustained-release delivery can help avoid the risk of sudden higher-blood concentration of a drug to avoid toxicity.
Experimental Considerations in Headspace Gas Chromatography
By Laila Kott , Hong Ming Chen
In this case study of amines, the authors discuss several parameters to be considered in developing a headspace GC method.
From The Editor
A Very Brady FDA
By Michelle Hoffman
FDA wants industry to talk to them about the science underlying process innovations—really.
PharmTech Talk
Inactive Excipients and Other Myths
By Angie Drakulich
Agreement on standards for excipient qualification, development, and fair pricing is underway.
Agent-in Place
Mixed Blessings
By Control, a senior compliance officer
When vessels, seals, and cooling units go haywire, operators must get in the mix.
News
Report from Brazil
By Hellen Berger
The growth of Brazil's generic-drug market is on a fast track, but what are the projections for the sector's future?
In the Spotlight
In the Spotlight
Editors' Picks of pharmaceutical science and technology innovations
Washington Report
Health Reform to Transform Coverage, Costs
By Jill Wechsler
Manufacturers will pay new fees but anticipate expanded drug use and safeguards for innovation.
Statistical Solutions
Statistical Solutions: Bergum's Method Recognized
By Lynn D. Torbeck
A method for determining sample size is finally getting some respect.
Insider Solutions
Inside USP: The USP Convention
By Susan J. Schniepp
Defining the Next Five Years.
Outsourcing Outlook
The Lilly Way
By Jim Miller
Eli Lilly faces up to the new realities of the bio/pharmaceutical industry through outsourcing.
Industry Leaders: Q&A
Q&A with Schenk AccuRate's Chad Lorensen
Lorensen discusses client demands and industry trends.
Viewpoint
Enterprise-Level Change Control
By Marina Aslanyan
A Pharma Business Imperative.

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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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