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Strategic Sourcing Focuses on Risk Mitigation

March 2, 2010
By:Patricia Van Arnum
Pharmaceutical Technology

Pharmaceutical companies and their suppliers share approaches in risk mitigation in sourcing and ways to optimize the outsourced relationship.

Opportunities in the Biosimilars Market

March 2, 2010
By:Patricia Van Arnum
Pharmaceutical Technology

Analysis of the opportunities and challenges in the biosimilars market.

The eCTD Upgrade: Cross-Application Linking

February 2, 2010
By:Michelle Perez
Pharmaceutical Technology

How to cut time and cost by re-using already submitted documents.

Specialty Pharmaceutical Focus: Pancreatic Enzyme Products

February 2, 2010
By:Patricia Van Arnum
Pharmaceutical Technology

A look at the formulation challenges in pancreatic enzyme products.

A PAT Solution for Automated Mill Control

January 2, 2010
By:Alon Vaisman, Yanhui Hu
Pharmaceutical Technology

The authors describe the implementation of an on-line particle-size analyzer on an active pharmaceutical ingredient milling operation at a commercial site.

Understanding Biological Indicator Grow-Out Times

January 2, 2010
By:John R. Gillis, Gregg A. Mosley, John B. Kowalski, Garrett Krushefski, Paul T. Nirgenau, Kurt McCauley
Pharmaceutical Technology

This study used biological indicators containing Geobacillus stearothermophilus spores and a new technology to continuously monitor incubated BIs and record nonsterile results.

A Perspective from FDA on ICH Q10 Pharmaceutical Quality System for Contract Manufacturers

January 2, 2010
By:Patricia Van Arnum
Pharmaceutical Technology

Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing.

Bringing a Science-Based Approach to Regulation: The Story of the Product Quality Research Institute

December 2, 2009
By:Gordon Hansen, Chris Allen
Pharmaceutical Technology

The authors describe the development and organization of the Product Quality Research Institute and highlight some of the important projects conducted by its Working Groups.

The Path to Product Stability Is through Water

December 2, 2009
By:Harry G. Brittain, PhD
Pharmaceutical Technology

Readers can learn about the importance of measuring and controlling water activity in a comprehensive new book.

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