Integrated Application of Quality-by-Design Principles to Drug Product and Its Control Strategy Development

Handbook of Pharmaceutical Wet Granulation ◽

10.1016/b978-0-12-810460-6.00023-3 ◽

2019 ◽

pp. 665-702

Author(s):

Sherif I.F. Badawy ◽

Ajit S. Narang ◽

Keirnan R. LaMarche ◽

Ganeshkumar A. Subramanian ◽

Sailesh A. Varia ◽

...

Keyword(s):

Control Strategy ◽

Quality By Design ◽

Drug Product ◽

Design Principles ◽

Strategy Development

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Using Quality by Design Principles as a Guide for Designing a Process Control Strategy

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture ◽

10.1002/9781119356189.ch7 ◽

2017 ◽

pp. 125-191

Author(s):

Christopher L. Burcham ◽

Mark LaPack ◽

Joseph R. Martinelli ◽

Neil McCracken

Keyword(s):

Process Control ◽

Control Strategy ◽

Quality By Design ◽

Design Principles

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Control strategy development guide for vaccine drug product

10.1016/b978-0-12-814357-5.00010-6 ◽

2022 ◽

pp. 279-295

Author(s):

Deep Bhattacharya ◽

Parag Kolhe

Keyword(s):

Control Strategy ◽

Drug Product ◽

Strategy Development

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Application of Quality by Design Principles to Support Development of a Control Strategy for the Control of Genotoxic Impurities in the Manufacturing Process of a Drug Substance

Organic Process Research & Development ◽

10.1021/op900242x ◽

2010 ◽

Vol 14 (4) ◽

pp. 993-998 ◽

Cited By ~ 31

Author(s):

Zadeo Cimarosti ◽

Fernando Bravo ◽

Paul Stonestreet ◽

Francesco Tinazzi ◽

Orsola Vecchi ◽

...

Keyword(s):

Control Strategy ◽

Manufacturing Process ◽

Quality By Design ◽

Design Principles ◽

Drug Substance ◽

Genotoxic Impurities

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Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film–Coated Tablets

Journal of Pharmaceutical Sciences ◽

10.1016/j.xphs.2015.11.023 ◽

2016 ◽

Vol 105 (1) ◽

pp. 168-181 ◽

Cited By ~ 24

Author(s):

Sherif I.F. Badawy ◽

Ajit S. Narang ◽

Keirnan R. LaMarche ◽

Ganeshkumar A. Subramanian ◽

Sailesh A. Varia ◽

...

Keyword(s):

Product Development ◽

Quality By Design ◽

Drug Product ◽

Design Principles ◽

Brivanib Alaninate

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Application of the Quality by Design Principles for the Development of the Crystallization Process for a Piperazinyl-Quinoline and Definition of the Control Strategy for Form 1

Organic Process Research & Development ◽

10.1021/op300126e ◽

2012 ◽

Vol 16 (10) ◽

pp. 1598-1606 ◽

Cited By ~ 3

Author(s):

Zadeo Cimarosti ◽

Sara Rossi ◽

Davide Tramarin ◽

Gilles Laval ◽

Paolo Stabile ◽

...

Keyword(s):

Control Strategy ◽

Quality By Design ◽

Crystallization Process ◽

Design Principles ◽

Definition Of

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Using Quality by Design Principles in Setting a Control Strategy for Product Quality Attributes

ACS Symposium Series - State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 1. Monoclonal Antibody Therapeutics: Structure, Function, and Regulatory Space ◽

10.1021/bk-2014-1176.ch005 ◽

2014 ◽

pp. 117-150 ◽

Cited By ~ 1

Author(s):

Gregory C. Flynn ◽

Gregg B. Nyberg

Keyword(s):

Product Quality ◽

Control Strategy ◽

Quality By Design ◽

Design Principles ◽

Quality Attributes

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Development of a NIR-based blend uniformity method for a drug product containing multiple structurally similar actives by using the quality by design principles

International Journal of Pharmaceutics ◽

10.1016/j.ijpharm.2015.04.025 ◽

2015 ◽

Vol 488 (1-2) ◽

pp. 120-126 ◽

Cited By ~ 18

Author(s):

Yiqing Lin ◽

Weiyong Li ◽

Jin Xu ◽

Pierre Boulas

Keyword(s):

Quality By Design ◽

Drug Product ◽

Design Principles ◽

Blend Uniformity

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Application of Quality by Design Principles to the Drug Product Technology Transfer Process

Quality by Design for Biopharmaceutical Drug Product Development - AAPS Advances in the Pharmaceutical Sciences Series ◽

10.1007/978-1-4939-2316-8_27 ◽

2015 ◽

pp. 661-692

Author(s):

Fredric J. Lim ◽

Jagannathan Sundaram ◽

Alavattam Sreedhara

Keyword(s):

Technology Transfer ◽

Transfer Process ◽

Quality By Design ◽

Drug Product ◽

Design Principles ◽

Technology Transfer Process ◽

Product Technology

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A Robust Procedure for On-Line Learning of Neural Networks in Control Strategy Development

Chemie Ingenieur Technik ◽

10.1002/1522-2640(200106)73:6<655::aid-cite6553333>3.0.co;2-4 ◽

2001 ◽

Vol 73 (6) ◽

pp. 655-656

Author(s):

L. Ender ◽

R. Maciel Filho

Keyword(s):

Neural Networks ◽

Control Strategy ◽

Strategy Development ◽

On Line ◽

On Line Learning

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Detention Storage Control Strategy Development

Journal of the Water Resources Planning and Management Division ◽

10.1061/jwrddc.0000003 ◽

1976 ◽

Vol 102 (1) ◽

pp. 117-135

Author(s):

Harry G. Wenzel ◽

Neil S. Grigg ◽

John W. Labadie

Keyword(s):

Control Strategy ◽

Strategy Development

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