Sven Stodtmann
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View article: Exposure–Response Modeling of Monthly Migraine Days for Efficacy of Atogepant in Patients With Episodic or Chronic Migraine
Exposure–Response Modeling of Monthly Migraine Days for Efficacy of Atogepant in Patients With Episodic or Chronic Migraine Open
This work aimed to develop an appropriate model to evaluate the exposure–response relationship (ERR) for monthly migraine days (MMD) in atogepant's key migraine prevention clinical trials to support dose selection. The ERR between atogepan…
View article: Population Pharmacokinetics of Atogepant for the Prevention of Migraine
Population Pharmacokinetics of Atogepant for the Prevention of Migraine Open
NCT03855137 (EudraCT number: 2018-004337-32).
View article: Model‐Informed Paradigm in Drug Development—An End‐To‐End Case Study From Upadacitinib Development
Model‐Informed Paradigm in Drug Development—An End‐To‐End Case Study From Upadacitinib Development Open
Model‐informed drug development (MIDD) entails applying quantitative approaches to assist with decision‐making during drug development and has been used for dose optimization, to inform clinical trial design, and to support clinical trial …
View article: Use of Model‐Based Meta‐Analysis to Inform the Design of Early Clinical Trials of Anti‐Amyloid Beta Therapies in Alzheimer's Disease
Use of Model‐Based Meta‐Analysis to Inform the Design of Early Clinical Trials of Anti‐Amyloid Beta Therapies in Alzheimer's Disease Open
To inform an efficient development of new investigational anti‐amyloid beta (anti‐Aβ) monoclonal antibodies (mAbs), a modeling‐and‐simulation‐based strategy was proposed. A general modeling framework that links drug exposures to the time c…
View article: Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials
Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials Open
Background Published evidence supporting efficacy of calcitonin gene-related peptide receptor antagonists as acute migraine treatments in males is limited. Methods To fill the gap, we present male and female data from four ubrogepant and f…
View article: Practical guide to <scp>SHAP</scp> analysis: Explaining supervised machine learning model predictions in drug development
Practical guide to <span>SHAP</span> analysis: Explaining supervised machine learning model predictions in drug development Open
Despite increasing interest in using Artificial Intelligence (AI) and Machine Learning (ML) models for drug development, effectively interpreting their predictions remains a challenge, which limits their impact on clinical decisions. We ad…
View article: Extrapolation of Upadacitinib Efficacy in Juvenile Idiopathic Arthritis Leveraging Pharmacokinetics, Exposure–Response Models, and Real‐World Patient Data
Extrapolation of Upadacitinib Efficacy in Juvenile Idiopathic Arthritis Leveraging Pharmacokinetics, Exposure–Response Models, and Real‐World Patient Data Open
Juvenile idiopathic arthritis (JIA) is the most prevalent pediatric rheumatic disease. While disease‐modifying antirheumatic drugs (DMARDs), especially biologics, have greatly transformed the management of JIA, there remain some unmet medi…
View article: Pharmacokinetics and Exposure–Response Analyses to Support Dose Selection of Upadacitinib in Crohn's Disease
Pharmacokinetics and Exposure–Response Analyses to Support Dose Selection of Upadacitinib in Crohn's Disease Open
Upadacitinib, a selective Janus kinase inhibitor, is the first orally administered therapy approved for the treatment of Crohn's disease (CD). This work characterized the pharmacokinetics of upadacitinib in CD patients and evaluated the re…
View article: SERENE ER Analysis Part 2 SERENE‐UC: Exposure‐response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients with Moderately to Severely Active Ulcerative Colitis
SERENE ER Analysis Part 2 SERENE‐UC: Exposure‐response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients with Moderately to Severely Active Ulcerative Colitis Open
SERENE UC (NCT02065622) evaluated whether a higher adalimumab induction regimen improved patients with ulcerative colitis (UC) response, but a flat dose‐response relationship was found in the induction study. We investigated exposure‐respo…
View article: Population pharmacokinetics and exposure‐response analyses for efficacy and safety of upadacitinib in patients with axial spondyloarthritis
Population pharmacokinetics and exposure‐response analyses for efficacy and safety of upadacitinib in patients with axial spondyloarthritis Open
Upadacitinib is an orally administered, selective, Janus kinase inhibitor that is approved for several auto‐immune conditions, such as axial spondyloarthritis, an inflammatory rheumatic disease that includes ankylosing spondylitis (AS) and…
View article: Integrating machine learning with pharmacokinetic models: Benefits of scientific machine learning in adding neural networks components to existing PK models
Integrating machine learning with pharmacokinetic models: Benefits of scientific machine learning in adding neural networks components to existing PK models Open
Recently, the use of machine‐learning (ML) models for pharmacokinetic (PK) modeling has grown significantly. Although most of the current approaches use ML techniques as black boxes, there are only a few that have proposed interpretable ar…
View article: Artificial Intelligence for Quantitative Modeling in Drug Discovery and Development: An Innovation and Quality Consortium Perspective on Use Cases and Best Practices
Artificial Intelligence for Quantitative Modeling in Drug Discovery and Development: An Innovation and Quality Consortium Perspective on Use Cases and Best Practices Open
Recent breakthroughs in artificial intelligence (AI) and machine learning (ML) have ushered in a new era of possibilities across various scientific domains. One area where these advancements hold significant promise is model‐informed drug …
View article: Upadacitinib Population Pharmacokinetics and Exposure-Response Relationships in Ulcerative Colitis Patients
Upadacitinib Population Pharmacokinetics and Exposure-Response Relationships in Ulcerative Colitis Patients Open
Data from studies NCT02819635 and NCT03653026 were included in these analyses.
View article: P341 Pharmacokinetics and exposure-response analyses of upadacitinib in patients with moderate to severe ulcerative colitis – Analyses of induction and maintenance clinical trials
P341 Pharmacokinetics and exposure-response analyses of upadacitinib in patients with moderate to severe ulcerative colitis – Analyses of induction and maintenance clinical trials Open
Background Upadacitinib (UPA), an oral selective and reversible JAK1 inhibitor, showed favorable efficacy and safety profile in Phase, 2b and, 3 studies in subjects with moderate to severe ulcerative colitis (UC). Population pharmacokineti…
View article: Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis
Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis Open
Elagolix is a novel, oral gonadotropin‐releasing hormone receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. Consistent wi…
View article: A Population Pharmacokinetic Meta‐Analysis of Veliparib, a PARP Inhibitor, Across Phase 1/2/3 Trials in Cancer Patients
A Population Pharmacokinetic Meta‐Analysis of Veliparib, a PARP Inhibitor, Across Phase 1/2/3 Trials in Cancer Patients Open
Veliparib (ABT‐888) is a poly(ADP‐ribose) polymerase inhibitor in development for the treatment of high‐grade ovarian cancer or BRCA ‐mutated breast cancer in combination with carboplatin and paclitaxel. The population pharmacokinetics of …
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: P515 Comparability of upadacitinib pharmacokinetics in Japanese and non-Japanese subjects with ulcerative colitis with the extended-release formulation
P515 Comparability of upadacitinib pharmacokinetics in Japanese and non-Japanese subjects with ulcerative colitis with the extended-release formulation Open
Background Upadacitinib (UPA), an oral selective JAK1 inhibitor, is being developed for treatment of patients with moderately-to-severely active ulcerative colitis (UC) in addition to several other inflammatory diseases. UPA has shown favo…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…