Application of a Statistical Approach to Process Development of Futibatinib by Employing Quality-by-Design Principles. Part 1: Identification of Critical Process Parameters for Impurities-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 1: Identification of Critical Process Parameters for Impurities

Published:2022-01-12 Issue:1 Volume:26 Page:43-55
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.1c00145

Reference25 articles.

1. The Impact of R. A. Fisher on Statistics

2. 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 31 Aug, 2021).

3. ICH Q8 Pharmaceutical Development, R2. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf (accessed 31 Aug, 2021).

4. ICH Q11 Development and Manufacture of Drug Substances. https://database.ich.org/sites/default/files/Q11%20Guideline.pdf (accessed 31 Aug, 2021).

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