Statistical Considerations in Design Space Development
The US Food and Drug Administration’s quality initiative for the 21st century seeks a new paradigm for pharmaceutical assessment. Design space and the statistics used in its development play an important role. The first in a three-part series, this article provides concise answers to frequently asked questions related to the statistical aspects of determining a design space as part of current quality-by-design initiatives. In parts II and III, the authors offer statistical tools used in experimental planning and strategy, as well as methods for evaluating the resulting design space and representing it graphically.

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ON DEMAND WEBCAST SERIES
Part 1: What's New in Pharmaceutical Laboratory Testing Requirements? Focus on: Heavy Metals

Part 2: What's New in Pharmaceutical Laboratory Testing Requirements? Focus on: Extractables and Leachables

Part 3: What's New in Pharmaceutical Laboratory Testing Requirements? Focus on: Melamine and Contamination Challenges

ON DEMAND
What Early Stage Companies Need to Know About Quality Management: Lessons Learned from Industry Leaders
What Early Stage Companies Need to Know About Quality Management: Lessons Learned from Industry Leaders Live Event Date/Time: June 23, 2010 at 11:00 AM EDT Life sciences companies are trying to cope with the mounting challenges of managing and maintaining quality systems while facing increased compliance risks. Clinical trials are becoming more complex and the FDA is scrutinizing data to a higher degree. This is leading to increased demands on quality organizations, and many are drowning in paper-based systems while struggling to maintain compliance. A panel of industry professionals will share, through a facilitated discussion, their experiences with deploying and realizing the benefits of QMS. They will discuss best practices they have implemented and lessons they have learned.

Expansion of Vetter Development Service (VDS)
Peter Soelkner
Managing Director, Vetter Pharma International GmbH

Providing effective ELSD and specialty HPLC instrumentation services.
Ticoscen truly understands the idiosyncrasy's ELSDs present and realize ELSDs are also often critical to a customer's day to day production, research and QC operations. Ticoscen is still the world's only independent separation sciences equipment servicing company on many brands of ELSDs. Our experience started with building custom Preparative HPLC instruments along with building prototypes, fabrication and manufacturing experience.