Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit

Arzu Selen; Maria T. Cruanes; Anette Müllertz; Paul A. Dicikinsion; Jack A. Cook; James E. Polli; Felippos Kesisoglou; John Crison; Kevin C. Johnson; Gordon T. Muirhead; Timothy Schofield; Yi Tsong

doi:10.1208/s12248-010-9206-0

Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit

Arzu Selen, Maria T. Cruanes, Anette Müllertz, Paul A. Dicikinsion, Jack A. Cook, James E. Polli, Felippos Kesisoglou, John Crison, Kevin C. Johnson, Gordon T. Muirhead, Timothy Schofield, Yi Tsong

29 Citations (Scopus)

Abstract

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.

Original language	English
Journal	The AAPS Journal
Volume	12
Issue number	3
Pages (from-to)	465-472
ISSN	1550-7416
DOIs	https://doi.org/10.1208/s12248-010-9206-0
Publication status	Published - Sept 2010

Keywords

Former Faculty of Pharmaceutical Sciences

Access to Document

10.1208/s12248-010-9206-0

Cite this

Selen, A., Cruanes, M. T., Müllertz, A., Dicikinsion, P. A., Cook, J. A., Polli, J. E., Kesisoglou, F., Crison, J., Johnson, K. C., Muirhead, G. T., Schofield, T., & Tsong, Y. (2010). Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit. The AAPS Journal, 12(3), 465-472. https://doi.org/10.1208/s12248-010-9206-0

Selen, A, Cruanes, MT, Müllertz, A, Dicikinsion, PA, Cook, JA, Polli, JE, Kesisoglou, F, Crison, J, Johnson, KC, Muirhead, GT, Schofield, T & Tsong, Y 2010, 'Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit', The AAPS Journal, vol. 12, no. 3, pp. 465-472. https://doi.org/10.1208/s12248-010-9206-0

@article{312bba809fc411df928f000ea68e967b,

title = "Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit",

abstract = "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.",

keywords = "Former Faculty of Pharmaceutical Sciences",

author = "Arzu Selen and Cruanes, {Maria T.} and Anette M{\"u}llertz and Dicikinsion, {Paul A.} and Cook, {Jack A.} and Polli, {James E.} and Felippos Kesisoglou and John Crison and Johnson, {Kevin C.} and Muirhead, {Gordon T.} and Timothy Schofield and Yi Tsong",

year = "2010",

month = sep,

doi = "10.1208/s12248-010-9206-0",

language = "English",

volume = "12",

pages = "465--472",

journal = "The AAPS Journal",

issn = "1550-7416",

publisher = "Springer",

number = "3",

}

TY - JOUR

T1 - Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting

T2 - product quality for patient benefit

AU - Selen, Arzu

AU - Cruanes, Maria T.

AU - Müllertz, Anette

AU - Dicikinsion, Paul A.

AU - Cook, Jack A.

AU - Polli, James E.

AU - Kesisoglou, Felippos

AU - Crison, John

AU - Johnson, Kevin C.

AU - Muirhead, Gordon T.

AU - Schofield, Timothy

AU - Tsong, Yi

PY - 2010/9

Y1 - 2010/9

N2 - 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.

AB - 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.

KW - Former Faculty of Pharmaceutical Sciences

U2 - 10.1208/s12248-010-9206-0

DO - 10.1208/s12248-010-9206-0

M3 - Review

C2 - 20517660

SN - 1550-7416

VL - 12

SP - 465

EP - 472

JO - The AAPS Journal

JF - The AAPS Journal

IS - 3

ER -

Meeting report: applied biopharmaceutics and quality by design for dissolution/release specification setting: product quality for patient benefit

Abstract

Keywords

Access to Document

Fingerprint

Cite this