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Model-Informed Drug Development: Steps Toward Harmonized Guidance.
Clin Pharmacol Ther. 2023 Nov;114(5):954-959. doi: 10.1002/cpt.3006. Epub 2023 Aug 3.
Clin Pharmacol Ther. 2023.
PMID: 37534711
No abstract available.
In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products.
Viceconti M, Pappalardo F, Rodriguez B, Horner M, Bischoff J, Musuamba Tshinanu F.
Viceconti M, et al. Among authors: musuamba tshinanu f.
Methods. 2021 Jan;185:120-127. doi: 10.1016/j.ymeth.2020.01.011. Epub 2020 Jan 25.
Methods. 2021.
PMID: 31991193
Free PMC article.
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General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy.
Li Z, Mirams GR, Yoshinaga T, Ridder BJ, Han X, Chen JE, Stockbridge NL, Wisialowski TA, Damiano B, Severi S, Morissette P, Kowey PR, Holbrook M, Smith G, Rasmusson RL, Liu M, Song Z, Qu Z, Leishman DJ, Steidl-Nichols J, Rodriguez B, Bueno-Orovio A, Zhou X, Passini E, Edwards AG, Morotti S, Ni H, Grandi E, Clancy CE, Vandenberg J, Hill A, Nakamura M, Singer T, Polonchuk L, Greiter-Wilke A, Wang K, Nave S, Fullerton A, Sobie EA, Paci M, Musuamba Tshinanu F, Strauss DG.
Li Z, et al. Among authors: musuamba tshinanu f.
Clin Pharmacol Ther. 2020 Jan;107(1):102-111. doi: 10.1002/cpt.1647. Epub 2019 Nov 10.
Clin Pharmacol Ther. 2020.
PMID: 31709525
Free PMC article.
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