Incorporating QbD Excipient Variability into Pharmaceutical Drug Product Design and Development: Perspective from an Excipient User
Posted on June 16, 2015
By: Joseph Kushner, IV, Ph.D.
Senior Principal Scientist
Drug Product Design
Worldwide Research & Development
Pfizer Inc
Abstract Excipients are an essential component of robust, commercial pharmaceutical drug products. Understanding variability in excipient material attributes is an integral part of drug product design and development. Several approaches are discussed for incorporating excipient variability understan...
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Related Topics and Keywords
Excipient, excipient composition and performance, Excipient User, excipients, ICH Q8(R2), IPEC-America, Joseph Kushner, patient safety and efficacy, Pfizer, Pharmaceutical Drug Product Design, Product Design and Development, QbD Excipient Variability, Quality-by-Design and excipient variability, regulatory flexibility, variability in excipient
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