Quality by Design (QbD): What Type of In Vivo-In Vitro Correlations are Feasible?
Byron PR.
Respiratory Drug Delivery 2008. Volume 1, 2008: 125-132.
Abstract:
While few debate the need for improved inhalers, or high quality drug delivery systems of any kind, deciding how to agree on what constitutes “high quality” and agreeing to use appropriate incentives and disincentives to promote quality-enhancing change in the products on the market is a challenge. While the most recent initiatives to adopt Quality by Design (QbD) are intended to stimulate improvements in product quality, it is unclear whether changes in chemistry manufacturing and control of new or existing platforms will stimulate improvements in clinically discernable safety and efficacy, largely because of the lack of published IVIVC data for orally inhaled drug products (OIP). Aspects of this topic will be discussed by a panel of regulators, industry scientists and academicians from statistical, regulatory and practical product development viewpoints.
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