Alexander Solms
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View article: Population pharmacokinetic–pharmacodynamic model of elinzanetant based on integrated clinical phase I and II data
Population pharmacokinetic–pharmacodynamic model of elinzanetant based on integrated clinical phase I and II data Open
Elinzanetant is a potent and selective dual neurokin‐1 (NK‐1) and ‐3 (NK‐3) receptor antagonist that is currently developed for the treatment of women with moderate‐to‐severe vasomotor symptoms (VMS) associated with menopause. Here, we rep…
View article: Pharmacokinetics, pharmacodynamics, and safety of fesomersen, a novel antisense inhibitor of factor XI, in healthy Chinese, Japanese, and Caucasian volunteers
Pharmacokinetics, pharmacodynamics, and safety of fesomersen, a novel antisense inhibitor of factor XI, in healthy Chinese, Japanese, and Caucasian volunteers Open
The inhibition of coagulation factor XI (FXI) presents an attractive approach for anticoagulation as it is not expected to increase the risk of clinically relevant bleeding and is anticipated to be at least as effective as currently availa…
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…
View article: Assessing QTc Effects of Vericiguat Using Two Different Concentration-QTc Modeling Approaches
Assessing QTc Effects of Vericiguat Using Two Different Concentration-QTc Modeling Approaches Open
ClinicalTrials.gov NCT03504982.
View article: Opportunities and Challenges of Disease Progression Modeling in Drug Development – An <scp>IQ</scp> Perspective
Opportunities and Challenges of Disease Progression Modeling in Drug Development – An <span>IQ</span> Perspective Open
Disease progression modeling (DPM) represents an important model‐informed drug development framework. The scientific communities support the use of DPM to accelerate and increase efficiency in drug development. This article summarizes Inte…
View article: Pharmacokinetic Parameter Driven Outcomes Model Predicts a Reduction in Bleeding Events Associated with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin- Free Method in a Chinese Healthcare Setting
Pharmacokinetic Parameter Driven Outcomes Model Predicts a Reduction in Bleeding Events Associated with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin- Free Method in a Chinese Healthcare Setting Open
Background: Long-term prophylactic therapy is considered the standard of care for hemophilia A patients. This study models the long-term clinical and cost outcomes of two factor VIII (FVIII) products using a pharmacokinetic (PK) simulation…
View article: PK/PD modeling of FXI antisense oligonucleotides to bridge the dose‐FXI activity relation from healthy volunteers to end‐stage renal disease patients
PK/PD modeling of FXI antisense oligonucleotides to bridge the dose‐FXI activity relation from healthy volunteers to end‐stage renal disease patients Open
IONIS‐FXI RX (BAY2306001) is an antisense oligonucleotide that inhibits the synthesis of coagulation factor XI (FXI) and has been investigated in healthy volunteers and patients with end‐stage renal disease (ESRD). FXI‐LICA (BAY2976217) sh…
View article: Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A
Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A Open
An open-label, crossover randomized study was performed to compare the pharmacokinetics (PK) of damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products indicated in patients with hemophilia A, both co…
View article: Late breaking Abstracts
Late breaking Abstracts Open
Background: Damoctocog alfa pegol (BAY 94-9027, Jivi ® ) and rurioctocog alfa pegol (BAX 855, Adynovi ® ) are PEGylated, extended half-life, recombinant factor VIII (FVIII) products, indicated for use in patients ≥ 12 years of age with hae…
View article: Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation
Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation Open
Rivaroxaban exposure and patient characteristics may affect the rivaroxaban benefit–risk balance. This study aimed to quantify associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety ou…
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…
View article: Population pharmacokinetic (PopPK) modelling indicates that patients switching to BAY 81‐8973 from rFVIII‐FS can continue their dosing schedule with improved protection
Population pharmacokinetic (PopPK) modelling indicates that patients switching to BAY 81‐8973 from rFVIII‐FS can continue their dosing schedule with improved protection Open
BAY 81-8973 (Kovaltry, Bayer, Berkeley, CA, USA) is an unmodified, full-length, recombinant factor VIII (rFVIII). It has the same primary amino-acid sequence as sucrose-formulated rFVIII (rFVIII-FS; Kogenate); however, BAY 81-8973 is produ…
View article: BAY 81‐8973 prophylaxis and pharmacokinetics in haemophilia A: Interim results from the TAURUS study
BAY 81‐8973 prophylaxis and pharmacokinetics in haemophilia A: Interim results from the TAURUS study Open
Objectives To report interim data from TAURUS, a study assessing real‐world prophylactic treatment with unmodified, full‐length recombinant FVIII BAY 81‐8973 (Kovaltry ® ; Bayer) indicated for haemophilia A. Methods TAURUS (NCT02830477) is…
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…
View article: Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A
Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A Open
BAY 94-9027 is an extended-half-life, recombinant factor VIII (rFVIII) product conjugated with a 60-kDa branched polyethylene glycol (PEG) molecule indicated for use in previously treated patients (aged ≥ 12 years) with hemophilia A. This …
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…
View article: Exposure–response relationship of regorafenib efficacy in patients with hepatocellular carcinoma
Exposure–response relationship of regorafenib efficacy in patients with hepatocellular carcinoma Open
After considering the baseline risk factors: ECOG performance status, alpha-fetoprotein levels, and hepatic function for OS and age for TTP, the ER analysis in regorafenib-treated patients showed similar efficacy over the entire predicted …