Pharmaceutical Technology, Jan 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Jan 2, 2012
Special Reports
Antibody-Drug Conjugates: Looking Ahead to an Emerging Class of Biotherapeutic
By Amy Ritter
Creating a successful antibody-drug conjugate requires careful selection of the drug, antibody, and linker.
Multilayer-Tablet Technology
By Rich Whitworth , Stephanie Sutton
Industry experts discuss formulation and technical challenges in multilayer tablet manufacture.
Special Features
FDA Perspectives: Designation of Regulatory Starting Materials in the Manufacturing of Drug Substances: Impact on ANDA Review Time
By Barbara Scott
The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application.
Peer-Reviewed Research
Assessing Tablet-Sticking Propensity
By Matthew P. Mullarney , Bruce C. MacDonald , Allan Hutchins
The authors designed an upper punch with a removable punch tip to determine a tablet formulation's propensity to stick by weighing the mass of powder adhered to the punch tip.
From The Editor
Here's to a Year of Compromise
By Angie Drakulich
The benefits of harmonization may be on industry's wish list, but buying into change is another story.
Inside USP
Inside USP: Global Harmonization Presents Opportunities and Challenges
By Anthony J. DeStefano, PhD , Kevin Moore
To keep moving forward, the Pharmacopoeial Discussion Group needs industry participation.
In the Field
Report from Europe
By Sean Milmo
The European Union market takes steps toward continuous processing and modular facilities.
Global Healthcare on the Ground: Brazil's Development Bank Leader Discusses the Country's Pharma Future
By Angie Drakulich
As part of the BRIC bloc with Russia, India, and China, Brazil is one of the world's leading emerging economies and is also considered by IMS Health to be one of seven pharmerging nations, which also include Mexico, Turkey, and South Korea.
PharmTech Talk
Cutting Prices to Save Sales
By Erik Greb
Copay coupons may help patients and drugmakers, but who ends up holding the bag?
Agent-in Place
All Systems Slow
By Control, a senior compliance officer
Technology may expedite operations, but the absence of the human element could cost dearly.
In the Spotlight
In the Spotlight
New product reviews for January 2012.
Washington Report
Budget Crunch, Political Battles Shape Policy Agenda for Year
By Jill Wechsler
Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.
BioForum
Venture-Capital Funding Falls but Shows Some Momentum
By Tracy T. Lefteroff
Challenges remain, particularly for early-stage biopharmaceutical companies.
Packaging Forum
Innovations for 2012
By Hallie Forcinio
Packaging innovations boost productivity, meet regulatory requirements, and protect products.
Pharma Ingredients
Broadening the Toolbox in Drug Development and Analysis
By Patricia Van Arnum
Some recent advances involve strategies for accelerating reaction discovery, approaches for inducing chirality and stereochemical analysis, and applications in nanotechnology for protein elucidation.
Formulation Development Forum: Nanosized Dendrimers
By Patricia Van Arnum
Nanosized systems are important in drug delivery. Such nanosized systems include liposomes, nanocrystals, micelles, colloidal particles, quantum dots, and dendrimers. Dendrimers are class of synthetic macromolecules with highly branched, monodispersed, circular, and symmetrical architecture that are used as carrier molecules in drug delivery.
Outsourcing Outlook
Contract Services in 2012
By Jim Miller
Some recent private-equity buyouts of CROs show both the upside and downside for investors.
Industry Leaders
Q&A with Gilles Cottier, SAFC
A Q&A with Gilles Cottier, president of SAFC, on recent industry trends.
Viewpoint
Innovator Liability Still Not Viable After Pliva v. Mensing
By Zach Hughes
Recent legal decisions have further divided generic and brand manufacturer cases.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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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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