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Dave Bower

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Recent Articles
1.
Myatt G, Bassan A, Bower D, Johnson C, Miller S, Pavan M, et al.
Comput Toxicol . 2022 Jan; 21. PMID: 35036665
Mechanistically-driven alternative approaches to hazard assessment invariably require a battery of tests, including both models and experimental data. The decision-making process, from selection of the methods to combining the information...
2.
Hasselgren C, Ahlberg E, Akahori Y, Amberg A, Anger L, Atienzar F, et al.
Regul Toxicol Pharmacol . 2019 Jun; 107:104403. PMID: 31195068
In silico toxicology (IST) approaches to rapidly assess chemical hazard, and usage of such methods is increasing in all applications but especially for regulatory submissions, such as for assessing chemicals...
3.
Amberg A, Andaya R, Anger L, Barber C, Beilke L, Bercu J, et al.
Regul Toxicol Pharmacol . 2018 Dec; 102:53-64. PMID: 30562600
The International Council for Harmonization (ICH) M7 guideline describes a hazard assessment process for impurities that have the potential to be present in a drug substance or drug product. In...
4.
Myatt G, Ahlberg E, Akahori Y, Allen D, Amberg A, Anger L, et al.
Regul Toxicol Pharmacol . 2018 Apr; 96:1-17. PMID: 29678766
The present publication surveys several applications of in silico (i.e., computational) toxicology approaches across different industries and institutions. It highlights the need to develop standardized protocols when conducting toxicity-related predictions....
5.
Amberg A, Beilke L, Bercu J, Bower D, Brigo A, Cross K, et al.
Regul Toxicol Pharmacol . 2016 Feb; 77:13-24. PMID: 26877192
The ICH M7 guideline describes a consistent approach to identify, categorize, and control DNA reactive, mutagenic, impurities in pharmaceutical products to limit the potential carcinogenic risk related to such impurities....