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of 6
pro vyhledávání: '"Giovanni Smania"'
Autor:
Pavan Vaddady, Giovanni Smania, Shintaro Nakayama, Hiroyuki Inoue, Abhinav Kurumaddali, Malaz Abutarif, Ming Zheng
Publikováno v:
Clinical and Translational Science, Vol 17, Iss 11, Pp n/a-n/a (2024)
Abstract Quizartinib prolongs QT interval through inhibition of the slow delayed rectifier potassium current (IKs). We used non‐linear mixed‐effects modeling to explore the relationship between quizartinib and its pharmacologically active metabol
Externí odkaz:
https://doaj.org/article/a96f31b91803433e8829fed07eb84c1f
Autor:
Giovanni Smania, E. Niclas Jonsson
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 4, Pp 330-339 (2021)
Abstract Clinical trial simulation (CTS) is a valuable tool in drug development. To obtain realistic scenarios, the subjects included in the CTS must be representative of the target population. Common ways of generating virtual subjects are based upo
Externí odkaz:
https://doaj.org/article/f4b65929d60a41c6a313471d8db917d2
Autor:
E. Niclas Jonsson, Giovanni Smania
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 4, Pp 330-339 (2021)
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 4, Pp 330-339 (2021)
Clinical trial simulation (CTS) is a valuable tool in drug development. To obtain realistic scenarios, the subjects included in the CTS must be representative of the target population. Common ways of generating virtual subjects are based upon bootstr
Publikováno v:
Blood. 136:7-8
Introduction: Adequate treatment and prevention of bleeding in patients with von Willebrand disease (VWD) requires replacement of von Willebrand factor (VWF) to thresholds often dictated by the clinical situation. While weight (WT)-based dosing is wi
Autor:
Oscar Della Pasqua, Meindert Danhof, Huixin Yu, Ramona Graf, Vincent F.S. Dubois, Giovanni Smania, Anne S. Y. Chain
Publikováno v:
British Journal of Clinical Pharmacology. 83:349-362
Aim In spite of screening procedures in early drug development, uncertainty remains about the propensity of new chemical entities (NCEs) to prolong the QT/QTc interval. The evaluation of proarrhythmic activity using a comprehensive in vitro proarrhyt
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology
Alternative designs can increase the feasibility of pediatric trials when compared to classical parallel designs (PaD). In this work we present a model-based approach based on clinical trial simulations for the comparison of PaD with the alternative