Pharmaceutical Technology, Jun 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Jun 2, 2012
Special Reports
Looking for Fingerprints: Bioanalytical Characterization of Biosimilars
By Amy Ritter
Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.
Special Features
Avoiding Contamination Risks in Aseptic Processes
By Benoit Verjans
How to avoid invisible and airborne contamination.
Preclinical Dose-Formulation Stability
By Amy Smith , Melissa Whitsel
When designing stability protocols, formulation, storage, and dosing conditions must be assessed.
Peer-Reviewed Research
Freeze-Drying Process Optimization for a Small Molecule
By Henning Gieseler, PhD , Susanne Hibler
The authors evaluate the thermal properties of gentamicin sulfate as a small-molecule drug model in optimizing the freeze-drying cycle.
Position Paper
GMPs for Small-Molecule Drugs in Early Development (Part I)
By Amnon Eylath , Brent Kleintop , Tony Mazzeo , James S. McElvain , Andy Rignall , John W. Skoug
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
Troubleshooting
Advanced Tablet-Coating Technologies Aid Manufacturing Efficiency
By Martin Hack
New coating technologies achieve high uniformity and reduce waste through mixing system advances and pan and airflow configuration.
Guest Editorial
Back-to-Basics with PDUFA V
By Sara Radcliffe
BIO is calling for a more patient-centric approach to user-fee reauthorization.
Inside USP
Inside USP: US Pharmacopeia Proposes New Standard on Glass Quality
By Anthony J. DeStefano, PhD , Desmond Hunt
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.
In the Field
Report from India
By Jane Wan
New price-control policy has domestic and global firms waiting on the sidelines to launch products.
Regulation and Compliance Q&A: Change Management
Q&A with Peter Smith, Strategic Compliance Consulting, PAREXEL International, and a former senior official with FDA, on change management best practices.
PharmTech Talk
Cheap versus Expensive
By Stephanie Sutton
UK chooses to use off-label drug indication to cut healthcare costs. Will others follow suit?
Agent-in Place
A "Big E" on the Scoreboard
By Control, a senior compliance officer
Even the slightest of errors in exponential calculations can cause the biggest of headaches.
Regulatory Watch
Manufacturers Back Innovation Initiatives
By Jill Wechsler
New legislation, government programs aim to bolster drug discovery and reduce regulatory hurdles.
In the Spotlight
In the Spotlight
New product reviews for June 2012.
BioForum
Innovation Boom Towns
By Christopher Milne
Partnerships between industry and academic medical centers are expanding to meet R&D needs.
Packaging Forum
New Packaging Technologies Displayed at INTERPHEX
By Hallie Forcinio
Highlights included the latest in pharmaceutical packaging equipment, containers, and labels and new capabilities among contract service providers.
Pharma Ingredients
Peptides Gain Traction in Drug Development
By Patricia Van Arnum
Peptides and related technologies to are starting to improve production.
Outsourcing Outlook
Biomanufacturing Innovation
By Eric Langer
Industry wants more innovation, but can suppliers meet customer needs?
Industry Leaders
Q&A with Larry Kadis, Federal Equipment
A Q&A with Larry Kadis, President and CEO of Federal Equipment, on recent industry trends.
Viewpoint
Biosimilar Developers Face a Reference-Product Dilemma
By Fiona Greer
Does global development have to entail multiple comparability studies?

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