Pharmaceutical Technology, Apr 2, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Apr 2, 2012
Special Reports
Navigating the Equipment and Machinery Market
By Patricia Van Arnum
Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2011 and planned for 2012.
Freeze-Drying: Is Technology Advancing Fast Enough?
By Stephanie Sutton
Experts discuss the best practices for developing a QbD-based lyophilization process.
Special Features
Compendial Globalization: Achieving Harmonization through Standardized Practices and Collaboration
By J. Mark Wiggins , Howard D. Schneider, Jr.
The authors discuss a new approach to address globally harmonized compendial standards.
Managing Product Supply Risks
By Sushil Abraham
How to use geographic diversification and legacy technology transfers to avoid product shortages.
Costs of Failure in Product Quality
By Satish Asotra , Alexander Cossin , Avraham Yacobi
The authors detail the possible consequences of noncompliance and a lack of quality control.
Product Quality Lifecycle Implementation
By Bruce Davis , Ranjit Deshmukh , John Lepore , Line Lundsberg-Nielsen , Roger Nosal , Stephen Tyler , Chris Potter
The authors provide an overview of the new ISPE Guide Series on Product Quality Lifecycle Implementation and how the guides can be used in a complementary way with existing guidance from FDA and the International Conference on Harmonization.
Gaining a Pulse on Formulation and Drug Delivery Challenges and Technologies
By Patricia Van Arnum
A recent survey examines the industry's views on the chief challenges and technologies in drug delivery and formulation development.
Inside INFORMEX: Evaluating the Market for Contract API Manufacturing
By Patricia Van Arnum
Contract API manufacturers and fine-chemical producers roll out capacity and service expansions.
Peer-Reviewed Research
Evaluating Impurities in Drugs (Part III of III)
By Kashyap R. Wadekar , Ponnaiah Ravi , Mitali Bhalme , S. Srinivasa Rao , K. Vigneshwar Reddy , L. Sampath Kumar , E. Balasubrahmanyam
In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.
Troubleshooting
Scale-up Challenges in Hot-Melt Extrusion
By Jennifer Markarian
Critical issues that should be considered when scaling up a hot-melt extrusion process.
Guest Editorial
A Look at INTERPHEX 2012
By Bob Stewart
Collaboration can begin with a conversation.
Inside PIC/S
Inside PIC/S: Top GMP Deficiencies
By Hans Smallenbroek , Boon Meow Hoe
Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.
In the Field
Report from China
By Jane Wan
China's drug-distribution network has been a mess for years, but government reforms and industry focus are unveiling new opportunities for market order and growth.
Regulation and Compliance: Deviation Investigations
Q&A with Peter Smith and David Elder, Strategic Compliance Consulting, PAREXEL International, on acceptable deviation investigations. Smith and Elder are both former senior officials with FDA.
PharmTech Talk
PDA Tackles Changing Industry Times
By Richard Johnson
The confluence of science, technology, and regulation can provide path forward.
Agent-in Place
Loose Lips Sink Ships
By Control, a senior compliance officer
Failure to disclose info may work sometimes, but eventually every question will be answered.
Regulatory Watch
Manufacturers Wrestle with Drug Abuse and Shortages
By Jill Wechsler
Soaring opioid use creates challenges for new drug development and supply-chain control.
In the Spotlight
In the Spotlight
New product reviews for April 2012.
BioForum
A Sustainable Biotech Path
By Glen Giovannetti
With financing constrained, biotechnology firms must find ways to sustain innovation.
Packaging Forum
Scoping out INTERPHEX
By Hallie Forcinio
Visitors will see many packaging innovations at the annual industry exhibition.
Pharma Ingredients
Expanding Excipient Portfolios
By Patricia Van Arnum
Excipient manufacturers expand production capacity and partner to broaden their offerings.
Statistical Solutions
Representative Sampling
By Lynn D. Torbeck
Understanding the differences between convenience, target, and self-selected samples.
Insider Solutions
Know the Regulations
By Susan J. Schniepp
The contract provider needs to know as much as the NDA holder.
Outsourcing Outlook
Ways to Recover Lost Margins
By Gregg Brandyberry
Recovery audits and other past practices in procurement can improve the bottom line.
Industry Leaders
Q&A with Erik van den Berg, AM-Pharma
A Q&A with Erik van den Berg, CEO of AM-Pharma, on recent industry trends.
Viewpoint
Clinical Trials of New Medicines
By John Castellani
The importance of new drug trials to patients, the economy, and science.

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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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