Results 11 to 20 of about 6,306 (210)
Advances in Pharmacological and Pharmaceutical Sciences, 2023 Pharmacotherapy, in many cases, is practiced at a suboptimal level of performance in low- and middle-income countries (LMICs) although stupendous amounts of data are available regularly.
Muhammad Usman +5 more
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Pharmacometrics approaches and its applications in diabetes: An overview
Journal of Pharmacy and Bioallied Sciences, 2021 Type 2 diabetes mellitus is the most prevalent and progressive in nature. As the time progress, the multifaceted complications and comorbidities associated to diabetes worsen in the form of macrovascular or microvascular or both. Pharmacometrics modeling
Sohail Aziz +3 more
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Variable or variate? A conundrum in pharmacometrics exposure–response models
CPT: Pharmacometrics & Systems Pharmacology, 2023 Key elements of scientific writing—consistency and clarity—can be compromised in case of inaccurate use of methodological terms, especially in complex and multidisciplinary scientific fields.
Ana‐Marija Grisic +3 more
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Pharmacometrics: Focus on the Patient [PDF]
CPT: Pharmacometrics & Systems Pharmacology, 2014 Pharmacometrics, whether using simple or complex models, has contributed to rational and efficient drug development,(1-3) with the main focus on early drug development.(4) This article describes why opportunities more directly focused on the patient abound in late stage development, illustrating the concept with three innovative examples which focus on
Dumitrescu, T Pene +2 more
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CPT: Pharmacometrics & Systems Pharmacology, 2021 Pediatric extrapolation is essential for bringing treatments to the pediatric population, especially for indications where the recruitment of pediatric patients into clinical trials is difficult and where fully powered trials are impossible.
Thomas Dumortier +2 more
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The clinical utility of pharmacometric models [PDF]
British Journal of Clinical Pharmacology, 2018 Pharmacometric models are powerful tools that can be used for a variety of purposes in clinical pharmacology, drug development and dose individualization. Lewis Sheiner famously described the process of learning versus confirming in the setting of drug development 1 and as applied to pharmacometrics.
Shaun S. Kumar +3 more
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CPT: Pharmacometrics & Systems Pharmacology, 2021 The success of applications of physiologically‐based pharmacokinetic (PBPK) modeling in drug development and drug labeling has triggered regulatory agencies to demand rigorous demonstration of the predictive capability of the specific PBPK platform for a
Sebastian Frechen +7 more
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CPT: Pharmacometrics & Systems Pharmacology, 2020 This modeling and simulation analysis was aimed at selecting doses of cinpanemab (BIIB054), a monoclonal antibody targeting aggregated α‐synuclein, for a phase II study in Parkinson’s disease (PD).
Mita Kuchimanchi +4 more
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Frontiers in Pharmacology, 2020 Physiologically based pharmacokinetic (PBPK) models are increasingly used to support pediatric dose selection for small molecule drugs. In contrast, only a few pediatric PBPK models for therapeutic antibodies have been published recently, and the ...
Sumit Basu +6 more
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Clinical and Translational Science, 2021 Antibody drug conjugates (ADCs) provide targeted delivery of cytotoxic agents directly inside tumor cells. However, many ADCs targeting solid tumors have exhibited limited clinical efficacy, in part, due to insufficient penetration within tumors.
Jared Weddell +4 more
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