Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit.
A biopharmaceutics and Quality by Design (QbD) conference was held on June 10-12, 2009 in Rockville, Maryland, USA to provide a forum and identify approaches for enhancing product quality for patient benefit. Presentations concerned the current biopharmaceutical toolbox (i.e., in vitro, in silico, pre-clinical, in vivo, and statistical approaches), as well as case studies, and reflections on new paradigms. Plenary and breakout session discussions evaluated the current state and envisioned a future state that more effectively integrates QbD and biopharmaceutics. Breakout groups discussed the following four topics: Integrating Biopharmaceutical Assessment into the QbD Paradigm, Predictive Statistical Tools, Predictive Mechanistic Tools, and Predictive Analytical Tools. Nine priority areas, further described in this report, were identified for advancing integration of biopharmaceutics and support a more fundamentally based, integrated approach to setting product dissolution/release acceptance criteria. Collaboration among a broad range of disciplines and fostering a knowledge sharing environment that places the patient's needs as the focus of drug development, consistent with science- and risk-based spirit of QbD, were identified as key components of the path forward.
Food and Drug Administration, Silver Spring, Maryland, USA. Arzu.Selen@fda.hhs.gov
Arzu
A
Selen
Maria T
MT
Cruañes
Anette
A
Müllertz
Paul A
PA
Dickinson
Jack A
JA
Cook
James E
JE
Polli
Filippos
F
Kesisoglou
John
J
Crison
Kevin C
KC
Johnson
Gordon T
GT
Muirhead
Timothy
T
Schofield
Yi
Y
Tsong
D001688:Biological Products; D012995:Solubility
D001688:Biological Products