Automated multifactorial design of experiment and Bayesian optimisation algorithm approaches to method development for the green analysis by supercritical fluid chromatography of a pharmaceutical ingredient

Author:

Brunelli Claudio,Osborne Ryan,Yule Greg,Dixon TomORCID,Bruce Isobel,Taylor Mark

Publisher

Elsevier BV

Reference43 articles.

1. ICH HARMONISED GUIDELINE - INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE - ANALYTICAL PROCEDURE DEVELOPMENT Q14. https://database.ich.org/sites/default/files/ICH_Q14_Document_Step2_Guideline_2022_0324.pdf.

2. Roman Szucs, Claudio Brunelli, Francois Lestremau, Melissa Hanna-Brown, Liquid chromatography in the pharmaceutical Industry, CHAPTER 17 in C. Poole Handbooks in Separation Science - Liquid Chromatography - Applications, Vol.2, applications, p515, Elsevier.

3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: specifications: test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: chemical Substances Q6A. Available online: https://database.ich.org/sites/default/files/Q6A%20Guideline.pdf (accessed on 14 November 2020).

4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: impurities in New Drug Substances Q3A(R2). Available online: https://database.ich.org/sites/default/files/Q3A%28R2%29%20Guideline.pdf (accessed on 31 July 2020).

5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: validation of Analytical Procedures: text and Methodology Q2(R1). Available online: https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf (accessed on 31 July 2020).

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