Risk-based Quality by Design (QbD): A Taguchi Perspective on the Assessment of Product Quality, and the Quantitative Linkage of Drug Product Parameters and Clinical Performance

Robert P. Cogdill; James K. Drennen

doi:10.1007/s12247-008-9025-3

Risk-based Quality by Design (QbD): A Taguchi Perspective on the Assessment of Product Quality, and the Quantitative Linkage of Drug Product Parameters and Clinical Performance

Journal of Pharmaceutical Innovation ◽

10.1007/s12247-008-9025-3 ◽

2008 ◽

Vol 3 (1) ◽

pp. 23-29 ◽

Cited By ~ 23

Author(s):

Robert P. Cogdill ◽

James K. Drennen

Keyword(s):

Product Quality ◽

Quality By Design ◽

Clinical Performance ◽

Drug Product

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Examining the Impact of Excipient Material Property Variation on Drug Product Quality Attributes: A Quality-By-Design Study for a Roller Compacted, Immediate Release Tablet

Journal of Pharmaceutical Sciences ◽

10.1002/jps.22455 ◽

2011 ◽

Vol 100 (6) ◽

pp. 2222-2239 ◽

Cited By ~ 31

Author(s):

Joseph Kushner ◽

Beth A. Langdon ◽

Jon I. Hiller ◽

Glenn T. Carlson

Keyword(s):

Product Quality ◽

Material Property ◽

Quality By Design ◽

Drug Product ◽

Immediate Release ◽

Quality Attributes ◽

Design Study ◽

Property Variation ◽

The Impact ◽

Release Tablet

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A quality-by-design study to develop Nifedipine nanosuspension: examining the relative impact of formulation variables, wet media milling process parameters and excipient variability on drug product quality attributes

Drug Development and Industrial Pharmacy ◽

10.1080/03639045.2018.1503296 ◽

2018 ◽

Vol 44 (12) ◽

pp. 1942-1952 ◽

Cited By ~ 10

Author(s):

Pooja J. Patel ◽

Bhavin Y. Gajera ◽

Rutesh H. Dave

Keyword(s):

Product Quality ◽

Process Parameters ◽

Quality By Design ◽

Drug Product ◽

Milling Process ◽

Relative Impact ◽

Design Study ◽

Media Milling ◽

Excipient Variability ◽

Formulation Variables

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A Quality-by-Design Study for an Immediate-Release Tablet Platform: Examining the Relative Impact of Active Pharmaceutical Ingredient Properties, Processing Methods, and Excipient Variability on Drug Product Quality Attributes

Journal of Pharmaceutical Sciences ◽

10.1002/jps.23810 ◽

2014 ◽

Vol 103 (2) ◽

pp. 527-538 ◽

Cited By ~ 23

Author(s):

Joseph Kushner ◽

Beth A. Langdon ◽

Ian Hicks ◽

Daniel Song ◽

Fasheng Li ◽

...

Keyword(s):

Product Quality ◽

Quality By Design ◽

Drug Product ◽

Active Pharmaceutical Ingredient ◽

Immediate Release ◽

Quality Attributes ◽

Relative Impact ◽

Design Study ◽

Processing Methods ◽

Excipient Variability

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Meeting Report: University of Wisconsin/ AAPS/FDA Workshop–Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit

Dissolution Technologies ◽

10.14227/dt160409p35 ◽

2009 ◽

Vol 16 (4) ◽

pp. 35-39 ◽

Cited By ~ 3

Author(s):

Vivian A. Gray

Keyword(s):

Product Quality ◽

Quality By Design ◽

Meeting Report ◽

Patient Benefit ◽

University Of Wisconsin

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Quality by Design for Biopharmaceutical Drug Product Development

10.1007/978-1-4939-2316-8 ◽

2015 ◽

Cited By ~ 4

Keyword(s):

Product Development ◽

Quality By Design ◽

Drug Product

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Considerations for Biotechnology Product Quality by Design

Quality by Design for Biopharmaceuticals ◽

10.1002/9780470466315.ch2 ◽

2009 ◽

pp. 9-30 ◽

Cited By ~ 13

Author(s):

Steven Kozlowski ◽

Patrick Swann

Keyword(s):

Product Quality ◽

Quality By Design ◽

Biotechnology Product

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Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-020-00146-y ◽

2020 ◽

Vol 54 (5) ◽

pp. 1192-1198

Author(s):

Eiji Kajiwara ◽

Haruki Kamizato ◽

Mayumi Shikano

Keyword(s):

Product Quality ◽

Quality By Design ◽

Drug Approval ◽

Design Development ◽

New Drug ◽

Review Period

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Quality-by-Design III: Application of Near-Infrared Spectroscopy to Monitor Roller Compaction In-process and Product Quality Attributes of Immediate Release Tablets

AAPS PharmSciTech ◽

10.1208/s12249-014-0180-1 ◽

2014 ◽

Vol 16 (1) ◽

pp. 202-216 ◽

Cited By ~ 10

Author(s):

Ravikanth Kona ◽

Raafat M. Fahmy ◽

Gregg Claycamp ◽

James E. Polli ◽

Marilyn Martinez ◽

...

Keyword(s):

Infrared Spectroscopy ◽

Product Quality ◽

Near Infrared Spectroscopy ◽

Quality By Design ◽

Near Infrared ◽

Immediate Release ◽

Quality Attributes ◽

Roller Compaction

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USP/NF: Public Standards for Drug Product Quality

Journal of the American Pharmaceutical Association (1961) ◽

10.1016/s0003-0465(16)33781-8 ◽

1976 ◽

Vol 16 (11) ◽

pp. 603-604

Author(s):

Lee T. Grady

Keyword(s):

Product Quality ◽

Drug Product

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A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design

Journal of Pharmaceutical Sciences ◽

10.1002/jps.22545 ◽

2011 ◽

Vol 100 (8) ◽

pp. 3031-3043 ◽

Cited By ~ 53

Author(s):

Sheryl Martin‐Moe ◽

Fredric J. Lim ◽

Rita L. Wong ◽

Alavattam Sreedhara ◽

Jagannathan Sundaram ◽

...

Keyword(s):

Product Development ◽

Quality By Design ◽

Drug Product

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