Application of a Statistical Approach to Process Development of Futibatinib by Employing Quality-by-Design Principles. Part 3: Development of Design Space for Control of Particle Size Distribution-Reference-Cited by-同舟云学术

Application of a Statistical Approach to Process Development of Futibatinib by Employing Quality-by-Design Principles. Part 3: Development of Design Space for Control of Particle Size Distribution

Published:2022-01-12 Issue:1 Volume:26 Page:72-81
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Abe Yasunori¹^ORCID,Emori Kosuke¹

Affiliation:

1. Chemical Technology Laboratory, CMC Division, Taiho Pharmaceutical Co., Ltd., 200-22 Motohara, Kamikawa-machi, Kodama-gun, Saitama 367-0241, Japan

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.oprd.1c00147

Reference17 articles.

1. ICH Quality Implementation Working Group Points to Consider (R2) ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation. https://database.ich.org/sites/default/files/Q8_Q9_Q10_Q%26As_R4_Points_to_Consider_0.pdf (Accessed: 27 Aug 2021).

2. ICH Q8 Pharmaceutical Development (R2). https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf (Accessed: 27 Aug 2021).

3. ICH Q11 Development and Manufacture of Drug Substances. https://database.ich.org/sites/default/files/Q11%20Guideline.pdf (Accessed: 27 Aug 2021).

4. Design of Experiments (DoE) and Process Optimization. A Review of Recent Publications

5. Elucidation of the Mechanism of Endo-XaaC-terminal Peptide Impurity Formation in SPPS through DoE Investigation, Their Control, and Suppression

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