Pharmaceutical Technology, Sep 2, 2007 - Pharmaceutical Technology

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Pharmaceutical Technology, Sep 2, 2007
Online Exclusives
Supplements to the PQRI Workshop Results
Appendix: definitions and regulations, Federal Food, Drug, and Cosmetic Act; Appendix: definitions and regulations, Title 21 Code of Federal Regulations; Appendix: definitions and regulations, Compliance Policy Guides
How to Gain Approval Overseas
By Naushad Khan Ghilzai
A comprehensive book helps readers navigate the European drug-approval process.
The Challenges and Opportunities in ICH Q10
By Patricia Van Arnum
Jason Kamm, managing consultant with Tunnell Consulting discusses the challenges and opportunities for pharmaceutical manufacturers in ICH Q10, the draft guidance on pharmaceutical quality systems issued by the International Conference on Harmonization.
Advances in Asymmetric Synthesis
By Patricia Van Arnum
Researchers forward approaches for catalytic hydroformylation, asymmetric hydrogenation, and biocatalysis to achieve enantioselectivity.
Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies
By Brian Carlin , Dale Carter , Moira Griffiths , Gregory Larner , Kevin Moore , Barry Rothman , David Schoneker , Catherine Sheehan , Rajendra Uppoor , Phyllis Walsh , Robert Wiens
This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.
Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Environment
By Laura Foust , Myron Diener , Mary Ann Gorko , Jeff Hofer , Gregory Larner , David LeBlond , Jerry Lewis , Dennis Sandell , Tim Schofield , Kim Vukovinsky , Ed Warner
Larger and strategic sampling and testing plans can improve process understanding and characterization.
Lubrication of Direct-Compressible Blends with Magnesium Stearate Monohydrate and Dihydrate
By Patrick Okoye , Stephen H. Wu
The influence of magnesium stearate (MgSt) on powder lubrication and finished solid-dose properties presents big challenges to drug manufacturers.
Revolution in Progress
By Gilles Valentin , Emmanuelle Berthemet
How the Indian pharmaceutical sector is reinventing itself
Case Studies
By Gilles Valentin , Emmanuelle Berthemet
Profiles in Biotechnology, Standards, Machinery, Innovation, Global Know-how, Strategies, and Expansion
By Gilles Valentin , Emmanuelle Berthemet
In a nation of more than 1 billion people, the importance of vaccines goes beyond healthcare—it is a matter of national security. Armed with this belief and a philanthropic vision that most Indians could be protected against hepatitis, DT–Polio, and other afflictions, Dr. Varaprasad Reddy entered the nascent Indian biotechnology sector in 1992 and has since managed to threaten the monopoly of large laboratories. That year, the Hepatitis B vaccine cost $33 per shot, and yet some families were subsisting on less than $1 a day. Meanwhile, India was importing only 180,000 doses per year.
Useful Contacts
By Gilles Valentin , Emmanuelle Berthemet
Useful Contacts
ICH-Q10: A Recipe for the Product Life Cycle
By Patricia Van Arnum
The draft guidance ICH Q10 for pharmaceutical quality systems is part of the ongoing move to a science- and risk-based approach in manufacturing.
Washington Report
Enhancing Drug Safety
By Jill Wechsler
User-fee legislation will require more testing and data disclosure to prevent unsafe drug use.
Packaging Forum
Printing Digital Labels
By Hallie Forcinio
Going digital can produce high-quality, full-color labels at potentially lower cost.
CMOs Join Pharma Facility Swap Meet
By Jim Miller
Contract manufacturers slim down to improve profitability.
By Control, a senior compliance officer
Poor processing and misguided projections lead to trashed product.
A Call for FDA Inspections
By Joseph Acker
FDA must increase inspections of foreign API manufacturing facilities as more production moves offshore.
From The Editor
It's in the Genes
By Michelle Hoffman
In an age of "pre-existing conditions," can a new bill help patients get the treatment they need?
This Time Around
Let's Get Publishing
By Angie Drakulich
When it comes to research, the United States scientific community is still way ahead of the game, but we're not sharing our findings as often as we should. According to a new National Science Foundation (NSF) report, the number of science and engineering articles by US-based authors published in major peer-reviewed journals has plateaued.
In the Field
In The Field
US and China Crack Down on Regulation after SFDA Chief Executed; Xcellerex Receives US Grant for Biopharmaceutical Production; New FDA Guidance on Polymorphic Compounds in Generic Drugs; Comment Periods Open for ICH Q10 and Biologics Guidelines
Pharma Capsules
Pharma Capsules
News and Views
In the Spotlight
In the Spotlight
Robust module facilitates filter changes; Rupture disks provide high-volume flow; Auger feeder avoids cross contamination


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Finance development of drugs to treat/prevent disease.
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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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