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Real-Time Attribute Measurement in High Shear Wet Granulation: An Evolving...

Ajit Narang, Ph.d., works for the Drug Product Science & Technology Department of Bristol-Myers Squibb Co. in New Brunswick, N.J. on …Continue reading →

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Enhanced Approaches for Development and Utilization of Analytical Procedures

By Kenneth Norris For the past several years, AAPS and its Analysis and Pharmaceutical Quality (APQ) section have been discussing …Continue reading →

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Quality by Design for Biologic Drugs

By Feroz Jameel, Susan Hershenson, Mansoor A. Khan, and Sheryl Martin-Moe What does implementation of a quality by design (QbD) …Continue reading →

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2015 Annual Meeting Themes: The Challenges of QbD

By Jahnavi Kharidia Today, the pharmaceutical industry’s antiquated drug development model is facing many challenges from the public and international regulatory …Continue reading →

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Scientific and Regulatory Considerations for Post-Approval Changes

By Sherif Badawy Over the past 10–15 years, the quality by design (QbD) approach for product development has emerged as an …Continue reading →

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