Pharmaceutical Technology, Aug 2, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 2, 2008
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Pharmaceutical Quality Systems
By Angie Drakulich
Myth versus Reality: What does Q10 implementation really mean for my company?
A Guide That Perplexes
By Roger Dabbah
Despite its flaws, a recent release fills a need for books about pharmaceutical project management.
Extractables and Leachables: An Overview of Emerging Challenges
By Poonam Kushwaha , A. K. Madan
Extractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.
Special Report
All Roads Now Lead to Quality Systems
By Angie Drakulich
After five years in the making, the official pharmaceutical quality system is here. All three parties to ICH adopted a final version of Q10 and agreed to implement the guideline through their individual regulatory bodies.
Peer-Reviewed Research
An Alternative to the USP Disintegration Test for Orally Disintegrating Tablets
By Jae Han Park , Kevin M. Holman , Glenn A. Bish , Donald G. Krieger , Daniel S. Ramlose , Cliff J. Herman , Stephen H. Wu
The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
Comparing Calibration Technologies for Liquid-Handling Quality Assurance
By Richard Curtis , George Rodrigues
The authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.
Ingredients Insider
CMOs Invest in High-Potency Manufacturing
By Patricia Van Arnum
CMOs expand capacity and capabilities in high-potency manufacturing to meet strong demand for cytotoxic and other potent drugs.
Packaging Forum
Saved by the Delay
By Hallie Forcinio
Postponement of California's deadline gives the supply chain time to refine ePedigree solutions.
Outsourcing Outlook
Clinical Outsourcing Steams Ahead
By Jim Miller
CMC service providers are doing well, but clinical and preclinical CROs are doing even better.
Washington Report
Sentinel to Transform Drug Development and Oversight
By Jill Wechsler
FDA is modernizing adverse-event reporting as part of a revolution in drug-safety assessment.
News
Report From: Vietnam
By Jane Wan
Surrounded by competition, Vietnam's 2020 vision focuses on building a biotech sector worthy of its Asian neighbors—as well as the growing global biopharmaceutical market
Agent-In-Place
Suspicious Times
By Control, a senior compliance officer
Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.
Viewpoint
Can Big Pharma Produce the Next Generation of Medicines?
By John Patterson
Patent pressures, changing disease profiles, and higher costs force companies to fight for the top.
Inside USP
Inside USP: US Pharmacopeia Guideline for Pending Monographs
By Karen A. Russo , Roger L. Williams
USP's guideline for pending monographs can speed up publication of monograhs and time to market.
From The Editor
FDA and Medicare at Odds?
By Michelle Hoffman
Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.
PharmTech Talk
Charting Advances at CRS
By Patricia Van Arnum
This year's meeting of the Controlled Release Society unveiled a plethora of research insights.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations

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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 LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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