Pharmaceutical Technology, Apr 2, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Apr 2, 2008
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Journey to the Center of the Lung
By Erik Greb
What makes a drug ripe for respiratory delivery?
Tracking the Potential of Excipients
By Patricia Van Arnum
Excipient producers and industry observers share their perspectives on innovation for excipients.
Running a Marathon in Flip-Flops – Part 1: The Value of Incorporating Prerequisites into Process Validation
By Nancy Cafmeyer , Jonathan M. Lewis
Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.
Suppositories: The Incomplete Story
By Heinz Sucker, PhD
A reference book omits important information and ignores advanced testing procedures.
Special Report
Inhalable Drugs on the Launch Pad: Will They Take Off?
By Erik Greb
Companies continue to develop inhaled insulin and other drugs, despite the problems that Pfizer's "Exubera" experienced.
Peer-Reviewed Research
Equipment Hold-Time for Cleaning Validation
By Richard J. Forsyth
Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.
Spectrophotometric Determination of Lead
By Lang Lang , Konghwa Chiu , Qingyong Lang
The authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.
Inside IPEC
Inside IPEC-EUROPE: Pharmaceutical Excipients—The View from the EU
By Phil Taylor
A changing regulatory environment is on the horizon for excipient suppliers and users.
Ingredients Insider
Measuring Excipient-Market Growth
By Patricia Van Arnum
Moderate growth is projected for the global excipients market. Excipient producers target blends and new grades for improving functionality and performance.
Outsourcing
Weak Link in the Pharmaceutical Supply Chain
By Jim Miller
The recent heparin contamination event calls for a new approach to manage a lengthening pharmaceutical supply chain.
Washington Report
FDA Inspection Program Under Scrutiny
By Jill Wechsler
Heparin contamination casts a shadow on regulatory oversight of product quality.
Packaging Forum
Innovations at INTERPHEX
By Hallie Forcinio
The annual show provided one-stop shopping for packaging equipment and materials.
Agent-In-Place
Vapors, Venison, and Videos
By Control, a senior compliance officer
Essential components of a good inspection: good ingredients, proper inserts, and ... deer?
Viewpoint
Science, Empiricism, and Off-label Use
By Janice M. Hogan
Was FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?
From The Editor
Message in a Bottle
By Michelle Hoffman
The FDA itself issues a cry for help. Is anybody listening?
PharmTech Talk
A Transformation in the Making
By Patricia Van Arnum
The economic case for personalized medicine offers a solution to the industry's recent woes.
News
Report From: China
By Yun-Tao Liu , Wan-Liang Lu
Although there have been recent setbacks for China with regard to exported products, the country has made substantial strides in its pharmaceutical industry over the past few years. Intense competition and a series of new regulations seem to be moving the country into a period of recovery.
Coming Down the Pike: Bispecific mABs
By Michelle Hoffman
Antibodies are highly specific molecules that can be tailored to recognize almost any stretch of peptide that nature can conjure: a feature that has been exploited for years now to produce therapeutic antibodies.
Trends: Holograms and Anticounterfeiting
By Ian Lancaster
Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry.
In the Spotlight
In the Spotlight
Manufacturers expect to see the latest developments in process equipment at INTERPHEX, and this year's show was no disappointment. Exhibitors regularly display additions to their lines of encapsulators, tablet presses, material-handling machines, and other automated manufacturing equipment. But the products on view in Philadelphia Mar. 26–28 were not limited to manufacturing applications.
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for April 2008.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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