Dirk Garmann
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View article: Population Pharmacokinetics of Asundexian in People at Risk for Thromboembolic/Cardiovascular Events
Population Pharmacokinetics of Asundexian in People at Risk for Thromboembolic/Cardiovascular Events Open
Asundexian is a potent, selective, and reversible inhibitor of activated clotting Factor XI currently under development for secondary prevention of recurrent ischemic stroke in the ongoing Phase III OCEANIC‐STROKE study (NCT05686070). Here…
Item response theory analysis of daytime sleepiness as a symptom of obstructive sleep apnea Open
Obstructive sleep apnea (OSA) is a sleep disorder which is linked to many health risks. The gold standard to evaluate OSA in clinical trials is the Apnea‐Hypopnea Index (AHI). However, it is time‐consuming, costly, and disregards aspects s…
View article: Evaluation of covariate effects in item response theory models
Evaluation of covariate effects in item response theory models Open
Item response theory (IRT) models are usually the best way to analyze composite or rating scale data. Standard methods to evaluate covariate or treatment effects in IRT models do not allow to identify item‐specific effects. Finding subgrou…
Model‐Based Benefit/Risk Analysis for the Copanlisib Intermittent Dosing Regimen Open
Copanlisib is an intravenously administered phosphatidylinositol 3‐kinase (PI3K) inhibitor, which is approved as monotherapy for relapsed follicular lymphoma in adult patients who have received at least two systemic therapies. In an April …
Pharmacokinetics and pharmacodynamics of finerenone in patients with chronic kidney disease and type 2 diabetes: Insights based on <span>FIGARO‐DKD</span> and <span>FIDELIO‐DKD</span> Open
Aims To perform dose–exposure–response analyses to determine the effects of finerenone doses. Materials and Methods Two randomized, double‐blind, placebo‐controlled phase 3 trials enrolling 13 026 randomized participants with type 2 diabet…
Pooled Exposure-Response (ER) and Quantitative Benefit/Risk (B/R) Analyses Support the Approved Copanlisib Intermittent Dosing Regimen Open
Introduction: Copanlisib is a potent and highly selective pan-class phosphatidylinositol 3-kinase (PI3K) inhibitor with preferential activity against the p110α and p110δ isoforms. Unlike other PI3K inhibitors, copanlisib is uniquely admini…
View article: Copanlisib population pharmacokinetics from phase I–III studies and exposure–response relationships in combination with rituximab
Copanlisib population pharmacokinetics from phase I–III studies and exposure–response relationships in combination with rituximab Open
Copanlisib dose selection was established under the maximum tolerated dose paradigm, and no dedicated dose‐finding studies have investigated copanlisib dose selection when used in combination with rituximab. In CHRONOS‐3, copanlisib plus r…
View article: Model‐informed approach to support pediatric dosing for the pan‐PI3K inhibitor copanlisib in children and adolescents with relapsed/refractory solid tumors
Model‐informed approach to support pediatric dosing for the pan‐PI3K inhibitor copanlisib in children and adolescents with relapsed/refractory solid tumors Open
Copanlisib is an intravenously administered phosphatidylinositol 3‐kinase (PI3K) inhibitor which was investigated in pediatric patients with relapsed/refractory solid tumors. A model‐informed approach was undertaken to support and confirm …
Finerenone Dose–Exposure–Serum Potassium Response Analysis of FIDELIO-DKD Phase III: The Role of Dosing, Titration, and Inclusion Criteria Open
The analyses demonstrated the effectiveness of finerenone dose titration in managing serum potassium and provide a quantitative basis to guide safe clinical use.
View article: Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction
Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction Open
NCT01951625.
NT‐proBNP Qualifies as a Surrogate for Clinical End Points in Heart Failure Open
N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) is a well‐established biomarker in heart failure (HF) but controversially discussed as a potential surrogate marker in HF trials. We analyzed the NT‐proBNP/mortality relationship in rea…
Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the prevention of venous thromboembolism Open
Anticoagulant plasma concentrations and patient characteristics might affect the benefit–risk balance of therapy. The study objective was to assess the impact of model-predicted rivaroxaban exposure and patient characteristics on outcomes …
View article: Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the treatment of venous thromboembolism
Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the treatment of venous thromboembolism Open
Anticoagulant plasma concentrations and patient characteristics might affect the benefit–risk balance of therapy. This study assessed the impact of model-predicted rivaroxaban exposure and patient characteristics on outcomes in patients re…
Favorable Pharmacokinetic Characteristics of Extended-Half-Life Recombinant Factor VIII BAY 94-9027 Enable Robust Individual Profiling Using a Population Pharmacokinetic Approach Open
This analysis evaluated the pharmacokinetics of BAY 94-9027 and its sources of IIV. Using the model, determination of individual patient pharmacokinetics was possible with few FVIII samples, and a sparse sampling design to support pharmaco…
View article: Bayesian Forecasting Utilizing Bleeding Information to Support Dose Individualization of Factor VIII
Bayesian Forecasting Utilizing Bleeding Information to Support Dose Individualization of Factor VIII Open
Bayesian forecasting for dose individualization of prophylactic factor VIII replacement therapy using pharmacokinetic samples is challenged by large interindividual variability in the bleeding risk. A pharmacokinetic‐repeated time‐to‐event…
View article: Relationship between factor VIII activity, bleeds and individual characteristics in severe hemophilia A patients
Relationship between factor VIII activity, bleeds and individual characteristics in severe hemophilia A patients Open
Pharmacokinetic-based prophylaxis of replacement factor VIII (FVIII) products has been encouraged in recent years, but the relationship between exposure (factor VIII activity) and response (bleeding frequency) remains unclear. The aim of t…
View article: Enhancing the Quality of Rivaroxaban Exposure Estimates Using Prothrombin Time in the Absence of Pharmacokinetic Sampling
Enhancing the Quality of Rivaroxaban Exposure Estimates Using Prothrombin Time in the Absence of Pharmacokinetic Sampling Open
Prothrombin time ( PT ) is a measure of coagulation status and was assessed in the majority of patients in the rivaroxaban phase II and III clinical trials as a pharmacodynamic marker. In the absence of sufficient phase III pharmacokinetic…
Influence of model-predicted rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome Open
Background: This analysis aimed to evaluate the impact of rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome (ACS) and to determine whether therapeutic drug monitoring …
View article: Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations
Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations Open
The population pharmacokinetics (PK) of rivaroxaban have been evaluated in several population‐specific models. We developed an integrated population PK model using pooled data from 4,918 patients in 7 clinical trials across all approved in…
Population pharmacokinetic characterization of <span>BAY</span> 81‐8973, a full‐length recombinant factor <span>VIII</span>: lessons learned ‒ importance of including samples with factor <span>VIII</span> levels below the quantitation limit Open
Introduction The pharmacokinetics ( PK ), safety and efficacy of BAY 81‐8973, a full‐length, unmodified, recombinant human factor VIII ( FVIII ), were evaluated in the LEOPOLD trials. Aim The aim of this study was to develop a population P…