Pharmaceutical Technology, Jan 2, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Jan 2, 2008
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Pharmaceutical and Biopharmaceutical Manufacturing Advances in Ireland
By Patricia Van Arnum
Ireland seeks to maintain a leading position in pharmaceutical and biopharmaceutical manufacturing as it also builds its base in research.
How to Build a Better Outsourcing Relationship
By Erik Greb
What should contractors and their clients bear in mind when they collaborate on a project?
The Importance of Leachables and Extractables Testing for a Successful Product Launch
By Frances DeGrazio
FDA’s May 1999 container-closure guidance has accelerated the requirements for extractable and leachable testing of container-closure packaging components. Since that date, additional recommendations have been made by industry groups to clarify how these issues should be addressed.
Singapore Attracts Pharmaceutical Manufacturing Investment
By Patricia Van Arnum
Singapore moves forward with a plan to diversify its life science investment with projects in biologics and drug discovery.
Special Report
Outsourcing Clinical-Trial Materials Heats Up
By Erik Greb
The outsourcing of clinical-trial materials grows as pharmaceutical companies adapt to a changing market.
Manufacturing Investment in Puerto Rico
By Patricia Van Arnum
Puerto Rico seeks to build its standing in biopharmaceutical manufacturing and research as it retains its role in bulk pharmaceutical and dosage manufacturing for small molecules.
Peer-Reviewed Research
Assessing Hibiscus rosa-sinensis Linn as an Excipient in Sustained-Release Tablets
By Giresh K. Jani , Dhiren P. Shah
Natural gums and mucilage are biocompatible, cheap, readily available, and represent a potential source of excipients. The authors examine the functionality of mucilage extracted from the leaves of Hibiscus rosa-sinensis Linn as an excipient in a sustained-release tablet formulation.
Cocktail-Solvent Screening
By Tu Lee , Shi Ting Hung
The authors propose extending initial solvent screening for a single-solvent system to the cocktail solvent screening of binary and ternary solvent mixtures.
Setting Cleaning Validation Acceptance Limits for Topical Formulations
By M. Ovais , Lai Yeo Lian
There is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.
Articles
Custom Synthesis of APIs
By Patricia Van Arnum
Researchers and process chemists share approaches in synthesis of active ingredients and pharmaceutical intermediates.
Inside IPEC: New Excipient Evaluation Procedure
By Christopher C. DeMerlis , Jay M. Goldring , David R. Schoneker
Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.
Washington Report
Opportunities for 2008
By Jill Wechsler
As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.
Outsourcing
Old Model in New Clothes
By Jim Miller
The traditional pharmaceutical business model is disintegrating, but the new model is not much different.
Agent-In-Place
Trash and Treasures
By Control, a senior compliance officer
Process efficiency is measured not only by what is kept, but also by what is thrown away.
Viewpoint
How to Meet Regulatory Challenges in the New Year
By Patricia Santos-Serrão
With 2007 projects wrapped up, or so we hope, forward-looking companies need to take their next step.
From The Editor
Candidate Copout
By Michelle Hoffman
Fixing FDA lies in the hands of the government, but is the president-to-be paying attention?
PharmTech Talk
Quality Disconnect
By Angie Drakulich
QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.
News
In the Field
News, world briefs, facility roundup, events and other items for January 2008.
Coming Down the Pike: hES cells
By Michelle Hoffman
The most significant early-stage discovery to hit the journals in late 2007 were the dual announcements from two independent research groups that they turned adult human skin cells into cells with properties that are seemingly identical with human embryonic stem (hES) cells.
Report from: India
By A. Nair
The $6.3 billion Indian pharmaceutical industry is at a crossroad. Aiming to be the international home for quality drugs, which could in itself propel India's market to $20 billion by 2015 according to recent estimates, the generic hothouse is clearly moving beyond its earlier low-cost mindset.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for January 2008.

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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