Pharmaceutical Technology, Nov 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Nov 2, 2012
Online Exclusives
Protecting the Public
By Hallie Forcinio
Overt and covert packaging technologies evolve to authenticate drugs and fight counterfeits.
Special Report
Optimizing Early-Stage Drug Development
By Patricia Van Arnum
Pharmaceutical companies and contract service providers adapt strategies and capabilities to reduce costs and accelerate drug-development timelines.
Special Features
AAPS Workshop Summary
By Dilip R. Choudhury , Ramesh K. Sood , John Bobiak , Mark Alasandro , Steven W. Baertschi , Bekki Komas , M. J. Skibic , Brian W. Pack , Saji Thomas , Robert H. Seevers , Kim Huynh-Ba , Stephen Colgan
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.
EU Sets Guidelines for Biosimilar Monoclonal Antibodies
By Sean Milmo
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).
Examining the Growing Challenge of Extractables and Leachables
By Stephanie Sutton
Experts share insight into extractables and leachables testing, including high-risk products, analytical testing, and regulatory requirements from FDA and EMA.
Peer-Reviewed Research
Mean Kinetic Relative Humidity: A New Concept for Assessing the Impact of Variable Relative Humidity on Pharmaceuticals
By Garry Scrivens
This article introduces"mean kinetic relative humidity" for evaluating the impact of humidity variability.
Position Paper
An Industry Perspective on Harmonization and Implementation of ICH and USP Requirements
By Katherine Ulman , Neil Schwarzwalder , Andrew Teasdale , David Schoneker , Priscilla Zawislak
The US Pharmacopeia's revised General Chapters on elemental impurity limits and testing procedures are set to take effect in December 2012.
From The Editor
Knowledge is Power
By Angie Drakulich
Global tactics that incorporate online technologies and social media are reshaping disease response.
Guest Editorial
ISPE Annual Meeting Seeks to Foster Global Change
By Nancy Berg
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.
Agent-in Place
Frozen Assets
By Control, a senior compliance officer
Even when all is well at the facility, one must expect the worst while braving the elements.
In the Field
Q&A with Yves de Montcheuil of Talend
A Q&A with Yves de Montcheuil, vice-president of marketing at Talend, a provider of open-source integration software.
Report from Turkey
By Sean Milmo
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.
In the Spotlight
In the Spotlight
New product reviews for November 2012.
Regulatory Watch
Product Analysis Key to Biosimilar Development
By Jill Wechsler
Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.
BioForum
Weighing Access and Affordability
By Kenneth I. Kaitin , Joshua P. Cohen
Policymakers must balance fundamental issues involving access to medicines and pricing.
Troubleshooting
A Troubleshooting Guide for Topical Drug Manufacturing
By Michael Lowenborg
Consider critical process parameters and strategies to optimize the manufacturing process.
Pharma Ingredients
Partnering in Antibody Drug Conjugates
By Patricia Van Arnum
The promise of antibody drug conjugates is creating a network of partners among large pharma companies and specialized players.
Inside USP
A New Risk-based GMP Inspection Planning Tool
By Kevin O'Donnell
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.
Insider Solutions
Advice for Enhancing the Client–Sponsor Relationship
By Susan J. Schniepp
Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.
Viewpoint
How to Manage Effective Leadership when Change is the Only Constant
By Tracy Thurkow , Karen Gorman , Paula Butte
A disciplined approach to changing behavior can achieve change agility.
Industry Insider
Will Europe Discourage the Launch of New Alzheimer's Drugs?
By Nathan Jessop
Regulatory bureaucracy in Europe coupled with the demand for lower-priced medicines continues to hinder efforts in innovation for Alzheimer's disease.
Outsourcing Outlook
Creating a Holistic Procurement System
By Gregg Brandyberry
The procurement organization rethinks sourcing for maximum efficiency and results.
Analytical Solutions
Stability Program Management
By Deni Jo Williams
To support global stability practices, fundamental basics must be in place.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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