Monitor, evaluate and, as appropriate, engage in discussions related to research and regulatory recommendations for bioavailability (BA), bioequivalence (BE), in-vitro/in-vivo correlations (IVIVC), clinical inputs for Quality-by-Design (QbD) and similar topics.
Stay abreast of clinical research, and as appropriate collaborate with other organizations pursuing clinical topics for OINDPs.
Monitor regulatory developments related to chemistry, manufacturing and controls (CMC) and product development requirements.
Assess and respond to regulatory developments as appropriate.
Develop improved approaches, “best industry practices” and other recommendations for CMC and product development tests, such as delivered dose uniformity, aerodynamic particle sizing, material characterization and others.