Pharmaceutical Technology, Dec 2, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, Dec 2, 2011
Online Exclusives
Regulatory Compliance with One Eye on Cost
By Todd L. Cecil
A new book attempts to reduce the confusion and costs associated with regulatory compliance.
PQRI Case Study (7): PackOut Remedies to Minimize Contamination and Exposure
By Ted Frank , Stephen Brooks , Kristin Murray , Steve Reich , Ed Sanchez , Brian Hasselbalch , Kwame Obeng , Richard Creekmore
The seventh in a series of eight case studies from the Product Quality Research Institute focuses on packout remedies.
PQRI Case Study (8): Internal GMP Audit Program
By Ted Frank , Stephen Brooks , Kristin Murray , Steve Reich , Ed Sanchez , Brian Hasselbalch , Kwame Obeng , Richard Creekmore
The last in a series of eight case studies from the Product Quality Research Institute focuses on internal GMP audits.
Special Reports
Views from Pharma Leaders: A Year in Review and a Look Forward
By Patricia Van Arnum
Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.
The Employment Outlook Brightens
By Rich Whitworth , Amy Ritter
Readers react to the economic turmoil of the past year and look longingly forward to 2012.
Special Features
PQRI Case Study (6): Packaging Line GMP Optimization
By Ted Frank , Stephen Brooks , Kristin Murray , Steve Reich , Ed Sanchez , Brian Hasselbalch , Kwame Obeng , Richard Creekmore
The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.
Peer-Reviewed Research
The Development of a Floating Drug-Delivery System for Metronidazole
By Shamsuddin Sultan Khan , Mesbah Uddin Talukder
The authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.
Guest Editorial
Supporting Innovation Requires Consistency and Vision
By John Castellani
Political leaders need to consider the impact of the biopharmaceutical industry on the economy.
PharmTech Talk
Reinventing Invention
By Patricia Van Arnum
As 2011 comes to a close, a new paradigm of product development is ever more important.
Inside IPEC
Inside IPEC: IPEC Tackles Monographs, Impurities, Particles, and More
By Patricia Rafidison
As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.
In the Field
Global Healthcare on the Ground: USAID Works to Carry out President Obama's Global Health Initiative
By Angie Drakulich
Cultivating a productive investment environment will require partnerships with a range of stakeholders.
Report from Asia
By Jane Wan
Packaging is indeed headed to be a lead sector in the Asian pharmaceutical environment, but certain challenges must first be overcome.
Agent-in Place
Buzz Off the Product
By Control, a senior compliance officer
Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination.
In the Spotlight
In the Spotlight
New product reviews for December 2011, focusing on manufacturing.
Washington Report
FDA Revamps to Meet New Challenges
By Jill Wechsler
Added responsibilities and outside concerns prompt overhaul of agency's structure.
BioForum
Creating Innovation Nodes to Meet Unmet Medical Needs
By Kenneth I. Kaitin
Pharma companies must balance demand for new drugs while facing reduced R&D spending.
Statistical Solutions
Out-of-Specification Sample-Size Confusion
By Lynn D. Torbeck
Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.
Pharma Ingredients
Contract API Manufacturing: The Year in Review
By Patricia Van Arnum
Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.
Insider Solutions
Auditing by the Numbers
By Susan J. Schniepp
Contract organizations must have highly organized teams and plans to accommodate today's audits.
Outsourcing Outlook
Troublesome Signs for Bio/Pharmaceutical R&D
By Jim Miller
A dearth of late-stage candidates could hurt the pharmaceutical services market in the future.
Industry Leaders
Q&A with Deborah Tanner, Covance
A Q&A with Deborah Tanner, executive vice-president and group president of R&D laboratories at Covance, on recent industry trends.
Viewpoint
Developing and Sustaining a Quality Culture
By Ian Uydess , Chet Meyers
Employee training—at all levels—is crucial for moving forward with a successful risk- and quality-based manufacturing strategy.

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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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