Pharmaceutical Technology, Sep 2, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, Sep 2, 2011
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A Pharmaceutical Company's View on Supply-Chain Security: A Perspective from Pfizer
By Brian Johnson
The author offers perspectives on ways in which pharmaceutical companies and other stakeholders in the supply chain can confront the threat of counterfeit products, cargo theft, illegal diversion, and economically motivated adulteration.
Special Report
Continuous Progress in Continuous Manufacturing
By Patricia Van Arnum , Rich Whitworth
Industry buy-in is increasing as pharma companies proceed with select projects and research.
Regulators Debate Methods for Producing Water for Injection
By Erik Greb
Might European officials reverse their position on acceptable production methods?
Special Feature
FDA Perspectives: Understanding Challenges to Quality by Design
By Helen N. Winkle , Moheb M. Nasr
Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.
PQRI Case Study (3): Facility Biocontainment and Inactivation
By Ted Frank , Stephen Brooks , Kristin Murray , Steve Reich , Ed Sanchez , Brian Hasselbalch , Kwame Obeng , Richard Creekmore
The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.
Peer-Reviewed Research
Surface Neutralization System
By Mark A. Snyder , Daniel Yoshikawa , Larry J. Cummings
A new, robust method for protein elution from ceramic hydroxyapatite.
A Design of Experiments for Tablet Compression
By Matthew N. Bahr
The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.
From The Editor
Retrospection and Introspection at FDA
By Michelle Hoffman
A report commissioned by FDA evaluates the QbD program.
Inside ICH
Inside ICH: Quality Implementation and Harmonization Continue
By Georges France , Jean-Louis Robert
A summary of the latest steering committee and expert working groups' meeting.
In the Field
Report from Latin America
By Hellen Berger
Growth and change in Brazil and Mexico offer key opportunities for the region's pharmaceutical industry.
Global Healthcare on the Ground: IFPMA Engages Global Bodies to Push Health Efforts Forward
By Patricia Van Arnum
International Federation of Pharmaceutical Manufacturers and Associations takes global action to improve public health.
PharmTech Talk
Web 2.0 for Pharma Innovation
By Patricia Van Arnum
Internal and external Web-based communities are changing how pharma companies can innovate.
Agent-in Place
Knowing is Half the Battle
By Control, a senior compliance officer
Being aware of a forthcoming inspection or how a product was made can make a huge difference.
In the Spotlight
In the Spotlight
New product reviews for September 2011 focusing on manufacturing.
Washington Report
Washington Report: Manufacturers and FDA Gear Up for User-Fee Action
By Jill Wechsler
PDUFA renewal legislation sets stage for new policies affecting revenue, resarch, and oversight.
BioForum
The Case for Pediatric Exclusivity
By Christopher Milne
Reauthorization of pediatric exclusivity provisions looms in 2012 and debates begin anew.
Packaging Forum
Verification through Telecommunication
By Hallie Forcinio
Smartphones could become the product-authentication tool of choice. Contains online bonus material.
Pharma Ingredients
Building Toolboxes in Pursuit of Single-Enantiomer Drugs
By Patricia Van Arnum
Biocatalysis, chemocatalysis, and other chiral technologies continue to attract the investment dollars of CMOs and fine-chemical companies.
Formulation Development Forum: Microscale Hydrogels
By Patricia Van Arnum
Researchers at MIT and Harvard University report on new methods for producing microscale hydrogels.
Outsourcing Outlook
The EU Debt Crisis and CMOs
By Jim Miller
The EU debt crisis portends of possible negative repercussions for the dose CMO industry.
Industry Leaders
Q&A with John Plachetka, POZEN
A Q&A with John Plachetka, chair, president, and CEO of POZEN, on recent industry trends.
Viewpoint
Where in the World is the US Pharmacopeia?
By Susan J. Schniepp
After a series of structural changes, the author wonders whether USP is undergoing an identity crisis. USP CEO Roger L. Williams responds.

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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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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