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Pharmaceutical Technology-11-02-2012
Pharmaceutical Technology
Pharmaceutical Technology, November 2012 Issue (PDF)
November 02, 2012
Issue PDF
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Early-Stage Drug Development
Weighing Access and Affordability
November 02, 2012
BioForum
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Policymakers must balance fundamental issues involving access to medicines and pricing.
ISPE Annual Meeting Seeks to Foster Global Change
November 02, 2012
Guest Editorial
36
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At the inaugural joint FDA/ISPE conference on CGMP earlier this year, CDER Dirctor Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt QbD principles must be a top priority.
Product Analysis Key to Biosimilar Development
November 02, 2012
Regulatory Watch
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Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.
Partnering in Antibody Drug Conjugates
November 02, 2012
Pharma Ingredients
36
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The promise of antibody drug conjugates is creating a network of partners among large pharma companies and specialized players.
In the Spotlight November 2012
November 02, 2012
In the Spotlight
36
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New product reviews for November 2012.
Q&A with Yves de Montcheuil of Talend
November 02, 2012
In the Field
36
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A Q&A with Yves de Montcheuil, vice-president of marketing at Talend, a provider of open-source integration software.
A Troubleshooting Guide for Topical Drug Manufacturing
November 02, 2012
Troubleshooting
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Consider critical process parameters and strategies to optimize the manufacturing process.
Frozen Assets
November 02, 2012
Agent-in Place
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Even when all is well at the facility, one must expect the worst while braving the elements.
Creating a Holistic Procurement System
November 02, 2012
Outsourcing Outlook
36
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The procurement organization rethinks sourcing for maximum efficiency and results.
EU Sets Guidelines for Biosimilar Monoclonal Antibodies
November 02, 2012
Special Features
36
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The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).
Will Europe Discourage the Launch of New Alzheimer's Drugs?
November 02, 2012
Industry Insider
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Regulatory bureaucracy in Europe coupled with the demand for lower-priced medicines continues to hinder efforts in innovation for Alzheimer's disease.
Optimizing Early-Stage Drug Development
November 02, 2012
Special Report
36
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Pharmaceutical companies and contract service providers adapt strategies and capabilities to reduce costs and accelerate drug-development timelines.
Examining the Growing Challenge of Extractables and Leachables
November 02, 2012
Special Features
36
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Experts share insight into extractables and leachables testing, including high-risk products, analytical testing, and regulatory requirements from FDA and EMA.
AAPS Workshop Summary
November 02, 2012
Special Features
36
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A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Advice for Enhancing the Client–Sponsor Relationship
November 02, 2012
Insider Solutions
36
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Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.
Report from Turkey
November 02, 2012
In the Field
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The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.
Stability Program Management
November 02, 2012
Analytical Solutions
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To support global stability practices, fundamental basics must be in place.
Mean Kinetic Relative Humidity: A New Concept for Assessing the Impact of Variable Relative Humidity on Pharmaceuticals
November 02, 2012
Peer-Reviewed Research
36
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This article introduces"mean kinetic relative humidity" for evaluating the impact of humidity variability.
How to Manage Effective Leadership when Change is the Only Constant
November 02, 2012
Viewpoint
36
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A disciplined approach to changing behavior can achieve change agility.
Protecting the Public
November 02, 2012
Online Exclusives
36
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Overt and covert packaging technologies evolve to authenticate drugs and fight counterfeits.
An Industry Perspective on Harmonization and Implementation of ICH and USP Requirements
November 02, 2012
Position Paper
36
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The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012.
Knowledge is Power
November 02, 2012
From The Editor
36
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Global tactics that incorporate online technologies and social media are reshaping disease response.
A New Risk-based GMP Inspection Planning Tool
November 02, 2012
Inside USP
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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has finalized a risk-based inspection planning tool for inspectorates to use in applying science- and risk-based principles to planning GMP inspections.