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Incorporating Excipients Into QbD Studies For Drug Development â An Introduction
By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), Katherine Ulman (KLU Consulting), Joseph Zeleznik (IMCD)
This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design
, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation).
1
The International Conference on Harmonization’s (ICH) guidelines related to quality by design (QbD) primarily ICH Q8, as well as Q9, Q10, Q11, and Q12
2-6 are high level and focus on the active pharmaceutical ingredient (API) and finished drug product. Applying API logic to excipients can lead to counterproductive adaptations inconsistent with QbD principles.