Pharmaceutical Technology, Aug 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 2, 2012
Special Report
Measuring Growth in Big Pharma's Manufacturing Investment
By Patricia Van Arnum
Pharmaceutical Technology's annual manufacturing investment update shows slight gains in biopharmaceutical manufacturing and emerging markets and continued restructuring of supply networks.
Special Feature
Bioavailability Enhancement: When to Use Hot-Melt Extrusion versus Spray Drying
By Patricia Van Arnum
Enhancing bioavailability can be achieved through hot-melt extrusion or spray drying. Patricia Van Arnum interviews Bend Research to find out more about when to use each technique.
Peer-Reviewed Research
Carbon Measurement Methods for Cleaning Validation (Peer Reviewed)
By Robert Clifford , Minako Tanaka
The authors compare direct combustion with rinse and swab sampling methods.
Position Papers
Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)
By Richard Creekmore , Eleni Dokou , Amnon Eylath , Dennis Joiner , Michael Lovdahl , Jackson Pellett , Eric Schmitt , John W. Skoug
IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
Elemental Impurity Analysis
By Alan Cross
The author discusses how to manage pending pharmacopeial changes.
Supply Chain
Pharmaceutical-Based Cargo Security and Theft Prevention
By Brad Elrod
The author discusses strategies for preventing cargo theft.
From The Editor
The Truth About Drug Shortages
By Angie Drakulich
Manufacturers willing to report bad news about the supply can help reverse the shortage trend.
In the Field
Report from Japan
By Jane Wan
After a series of government reforms that are appealing to both domestic and foreign players, the Japanese pharmaceutical market is making a comeback.
Packaging Forum
Quality Control Advances
By Hallie Forcinio
Highly automated and sensitive quality-control equipment quickly identifies product faults.
PharmTech Talk
Healthcare Reform is Given the Go-Ahead: Now What?
By Jill Wechsler
No matter the upside or downside to the Affordable Care Act, there's work to be done.
Agent-in Place
Technology Fights Back
By Control, a senior compliance officer
Meticulous system configuration can prevent machines from taking over.
Regulatory Watch
FDA User-Fee Legislation Sets Stage for Change
By Jill Wechsler
Import controls and risk strategies aim to promote quality and spur new drug development.
In the Spotlight
In the Spotlight
New product reviews for August 2012.
BioForum
Small Changes, System-Wide Impact
By Simon Chalk , Steve Jones
A look at elastomer changeout times shows how industry knowledge improves operations and cost.
Statistical Solutions
A Statistical Review of ICH Q10 Pharmaceutical Quality System
By Lynn D. Torbeck
Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.
Pharma Ingredients
Scaling up API Syntheses
By Patricia Van Arnum
Approaches to scaling up API syntheses center on ways to optimize process conditions and operability.
Outsourcing Outlook
Gauging Biopharm Outsourcing
By Eric Langer
Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.
Industry Leaders
Q&A with Babu Padmanabhan, STEER Engineering
A Q&A with Babu Padmanabhan, Managing Director and Chief Knowledge Officer of STEER Engineering, on recent industry trends.
Viewpoint
Enactment of FDA Reform Act Improves Drug Safety
By John DiLoreto
New law provides FDA with the resources it needs to safeguard drug supply chain.

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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
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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