Application of Model-Free and Model-Based Quality-by-Control (QbC) for the Efficient Design of Pharmaceutical Crystallization Processes-Reference-Cited by-同舟云学术

Application of Model-Free and Model-Based Quality-by-Control (QbC) for the Efficient Design of Pharmaceutical Crystallization Processes

Published:2020-04-15 Issue:6 Volume:20 Page:3979-3996
ISSN:1528-7483
Container-title:Crystal Growth & Design
language:en
Short-container-title:Crystal Growth & Design

Author:

Szilagyi Botond¹^ORCID,Eren Ayse¹^ORCID,Quon Justin L.²,Papageorgiou Charles D.²^ORCID,Nagy Zoltan K.¹^ORCID

Affiliation:

1. Davidson School of Chemical Engineering, Purdue University, 610 Purdue Mall, West Lafayette, Indiana 47907, United States

2. Takeda Pharmaceuticals International Company, 40 Landsdowne Street, Cambridge, Massachusetts 02139, United States

Funder

Takeda Pharmaceuticals International Co

Publisher

American Chemical Society (ACS)

Subject

Condensed Matter Physics,General Materials Science,General Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.cgd.0c00295

Reference46 articles.

1. End-to-End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation

2. ICH-Q7, U.S. Food and Drug Administration (FDA), Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients - Guidance for Industry, Revision 1, September 2006.

3. Pharmaceutical Crystallization

4. Advanced control of crystallization processes

5. Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: A case of a learning process

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