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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: 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: Cedirogant Population Pharmacokinetics and Pharmacodynamic Analyses of Interleukin‐17A Inhibition in Two Phase 1 Studies in Healthy Participants and Participants with Moderate to Severe Psoriasis
Cedirogant Population Pharmacokinetics and Pharmacodynamic Analyses of Interleukin‐17A Inhibition in Two Phase 1 Studies in Healthy Participants and Participants with Moderate to Severe Psoriasis Open
Cedirogant (ABBV‐157) is an orally bioavailable inverse agonist of retinoic acid‐related orphan receptor gamma thymus. Data from 2 Phase 1 studies were used to characterize cedirogant pharmacokinetics and evaluate target engagement. Cediro…
View article: Venetoclax in biomarker‐selected multiple myeloma patients: Impact of exposure on clinical efficacy and safety
Venetoclax in biomarker‐selected multiple myeloma patients: Impact of exposure on clinical efficacy and safety Open
Venetoclax, a potent BCL‐2 inhibitor, is currently under development for treatment of t(11;14) Multiple myeloma (MM). The objective of this research was to investigate the exposure–response relationships of venetoclax for a phase 1/2 study…
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: Venetoclax exposure‐efficacy and exposure‐safety relationships in patients with treatment‐naïve acute myeloid leukemia who are ineligible for intensive chemotherapy
Venetoclax exposure‐efficacy and exposure‐safety relationships in patients with treatment‐naïve acute myeloid leukemia who are ineligible for intensive chemotherapy Open
This study evaluated venetoclax population pharmacokinetics (popPK) in patients with treatment‐naïve acute myeloid leukemia and assessed the relationship between venetoclax exposure and clinical response for venetoclax in combination with …
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: 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: Pharmacokinetics of Risankizumab in Asian Healthy Subjects and Patients With Moderate to Severe Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis
Pharmacokinetics of Risankizumab in Asian Healthy Subjects and Patients With Moderate to Severe Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis Open
Risankizumab, a humanized monoclonal antibody that targets interleukin‐23 p19 subunit, was developed for the treatment of psoriasis. This work characterizes risankizumab pharmacokinetics in Japanese and Chinese healthy subjects compared wi…
View article: Population pharmacokinetics of paritaprevir, ombitasvir, dasabuvir, ritonavir and ribavirin in hepatitis C virus genotype 1 infection: analysis of six phase III trials
Population pharmacokinetics of paritaprevir, ombitasvir, dasabuvir, ritonavir and ribavirin in hepatitis C virus genotype 1 infection: analysis of six phase III trials Open
Aim The aim of the current study was to characterize the population pharmacokinetics of a triple direct‐acting antiviral (DAA) regimen (3D) (ombitasvir, paritaprevir–ritonavir and dasabuvir) and adjunctive ribavirin, and estimate covariate…
View article: Pharmacokinetics and Exposure–Efficacy Relationship of Adalimumab in Pediatric Patients with Moderate to Severe Crohnʼs Disease
Pharmacokinetics and Exposure–Efficacy Relationship of Adalimumab in Pediatric Patients with Moderate to Severe Crohnʼs Disease Open
This study is the first to describe the PK of adalimumab in pediatric patients with moderate-to-severe Crohn's disease. A positive association between serum adalimumab concentration and remission/response was identified.