Pharmaceutical Technology, Jan 2, 2013 - Pharmaceutical Technology

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Pharmaceutical Technology, Jan 2, 2013
From The Editor
A Look Ahead for 2013
By Angie Drakulich
From time to time, it's important to take stock of the industry from both a retrospective and prospective point of view.
Cover Story
A Look Ahead at Manufacturing and Regulation
By Angie Drakulich
FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches.
Special Feature
Tablet Splitting: A New Focus for Regulators
Tablet splitting is a new area of focus for regulators. The FDA tells PTE more about the challenges in this area.
The Challenge for Manufacturers in Tablet Splitting
Dr. Charles Kettler, director of Natoli Scientific, looks at the challenges that tablet scoring poses to tablet manufacturers.
Peer-Reviewed Research
X-ray Powder Diffraction Pattern Indexing for Pharmaceutical Applications
By Richard B. McClurg , Jared P. Smit
The authors discuss the valuable information that can be obtained from indexing and its applications in routine screening and analysis of solid forms.
BioForum
The Transformation to Process-Centered Organization
By Simon Chalk
Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?
Regulation & Compliance
Drug Quality at Center Stage for FDA and Manufacturers
By Jill Wechsler
Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.
Falsified Medicines Directive Takes Shape in Europe
By Sean Milmo
The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.
Inside USP
Standards-Setting Activities on Impurities
By Maura Kibbey , Antonio Hernandez-Cardoso , Kahkashan Zaidi, PhD
USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
CMC Troubleshooting
Validation Requirements for Disinfection Efficacy
By John S. Kent
Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.
Global Feature
Report from Brazil
By Hellen Berger
The health ministry of Brazil recently signed an agreement to obtain its production technology to locally develop the antiretroviral drug atazavanir sulfate.
API Synthesis and Manufacturing
Strategies in API Scale Up
By Patricia Van Arnum
Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.
Outsourcing Outlook
Offshoring Biomanufacturing
By Eric Langer
Will international biomanufacturing outsourcing become mainstream in this decade?
Ask the Expert
EMA and FDA on Process Validation
Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.
News
Pharma Conversation & Community
By Stephanie Sutton
A round up of news from across the web, including trends from social social media platforms.
Product Spotlight
The Latest in IT/Automation/Process control
New product reviews for December 2012.

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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 WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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