Quality by Design for Generic Drugs

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
2011 AIChE Annual Meeting
AIChE Annual Meeting
October 17, 2011 - 8:00pm

To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed mock QbD examples for immediate release (IR) and modified release (MR) dosage forms. This presentation will provide insight into OGD’s current thinking on QbD filing requirement and definition of some QbD nomenclatures. The Question-based Review (QbR) system is to be revised in 2011 and 2012 and is expected to be fully implemented by January 2013. This presentation will also discuss some practical tools and types of pharmaceutical development studies ANDA applicants may use as they implement QbD in their pharmaceutical development process.
Professional Development Hours
0.5 PDHs
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