Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects With Type 2 Diabetes Mellitus

The G-protein-coupled receptor 40 agonist (GPR40) TAK-875 is being developed as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Pharmacometric approaches such as model-based exposure-response and meta-analyses were applied to (i) characterize exposure/dose-efficacy responses of TAK-875, (ii) characterize the time course of glycosylated hemoglobin A1c (HbA1c) […]

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Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond

High development cost, low development success, cost-disciplined health-care policies, and intense competition demand an efficient drug development process. New compounds need to bring value to patients by being safe, efficacious, and cost-effective as compared with existing treatment options. Model-based meta-analysis (MBMA) facilitates integration and utilization of summary-level efficacy and safety data, providing a quantitative framework […]

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Model-based covariate pharmacokinetic analysis and lack of cortisol suppression by the new inhaled corticosteroid ciclesonide using a novel cortisol release model

Ciclesonide is a novel and effective inhaled corticosteroid for the treatment of asthma that is converted into the active metabolite C21-desisobutyryl-ciclesonide (des-CIC) in the lung. The objectives of this analysis were to characterize covariate effects on des-CIC pharmacokinetics (PK) and circadian cortisol release. In addition, the effect of systemic des-CIC exposure on circadian cortisol release […]

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Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop.

Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science. In an effort to support and […]

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