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View article: Development and Verification of a Physiologically Based Pharmacokinetic Model of Furmonertinib and Its Main Metabolite for Drug–Drug Interaction Predictions
Development and Verification of a Physiologically Based Pharmacokinetic Model of Furmonertinib and Its Main Metabolite for Drug–Drug Interaction Predictions Open
Furmonertinib demonstrated potent efficacy as a newly developed tyrosine kinase inhibitor for the treatment of patients with epidermal growth factor receptor (EGFR) mutation‐positive non‐small cell lung cancer. In vitro research showed tha…
View article: A Joint Pharmacometric Model of Iohexol and Creatinine Administered through a Meat Meal to Assess GFR and Renal OCT2/MATE Activity
A Joint Pharmacometric Model of Iohexol and Creatinine Administered through a Meat Meal to Assess GFR and Renal OCT2/MATE Activity Open
Accurately assessing glomerular filtration rate (GFR) from plasma creatinine concentrations is challenging in patients with unstable renal function. This study aimed to refine the understanding of creatinine kinetics for more reliable asse…
View article: Validating Low‐Dose Iohexol as a Marker for Glomerular Filtration Rate by In Vitro and In Vivo Studies
Validating Low‐Dose Iohexol as a Marker for Glomerular Filtration Rate by In Vitro and In Vivo Studies Open
Clearance of an intravenous iohexol dose of 3235 mg is used to assess glomerular filtration rate (GFR), although systematic assessment of its pharmacokinetic (PK) properties is incomplete. The objectives of the present investigations were …
View article: Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043–02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial
Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043–02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial Open
EDCTP2 programme; German Ministry for Education and Research; German Center for Infection Research; InfectControl; Bavarian Ministry for Science and the Arts; Swiss State Secretariat for Education, Research, and Innovation; and Nederlandse…
View article: A Semi-Mechanistic Population Pharmacokinetic Model of Noscapine in Healthy Subjects Considering Hepatic First-Pass Extraction and CYP2C9 Genotypes
A Semi-Mechanistic Population Pharmacokinetic Model of Noscapine in Healthy Subjects Considering Hepatic First-Pass Extraction and CYP2C9 Genotypes Open
View article: Assessment of body mass-related covariates for rifampicin pharmacokinetics in healthy Caucasian volunteers
Assessment of body mass-related covariates for rifampicin pharmacokinetics in healthy Caucasian volunteers Open
View article: Understanding adefovir pharmacokinetics as a component of a transporter phenotyping cocktail
Understanding adefovir pharmacokinetics as a component of a transporter phenotyping cocktail Open
View article: Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units
Academia and industry agreement on a feasibility tool for first‐time‐in‐human clinical trial units Open
First‐time‐in‐human (FTIH) trials are designed to generate information on the safety, tolerability, as well as the pharmacokinetic and pharmacodynamics profile of new drugs. To ensure the safety of participants, these trials need to be con…
View article: Drug interaction potential of high-dose rifampicin in patients with pulmonary tuberculosis
Drug interaction potential of high-dose rifampicin in patients with pulmonary tuberculosis Open
Accumulating evidence supports the use of higher doses of rifampicin for tuberculosis (TB) treatment. Rifampicin is a potent inducer of metabolic enzymes and drug transporters, resulting in clinically relevant drug interactions. To assess …
View article: Improved correction formulas to estimate iohexol clearance from simple models
Improved correction formulas to estimate iohexol clearance from simple models Open
View article: Cefepime Population Pharmacokinetics, Antibacterial Target Attainment, and Estimated Probability of Neurotoxicity in Critically Ill Patients
Cefepime Population Pharmacokinetics, Antibacterial Target Attainment, and Estimated Probability of Neurotoxicity in Critically Ill Patients Open
Cefepime has been reported to cause concentration-related neurotoxicity, especially in critically ill patients with renal failure. This evaluation aimed to identify a dosing regimen providing a sufficient probability of target attainment (…
View article: Physiologically Based Pharmacokinetic Modeling of Bergamottin and 6,7‐Dihydroxybergamottin to Describe <scp>CYP3A4</scp> Mediated Grapefruit‐Drug Interactions
Physiologically Based Pharmacokinetic Modeling of Bergamottin and 6,7‐Dihydroxybergamottin to Describe <span>CYP3A4</span> Mediated Grapefruit‐Drug Interactions Open
Grapefruit is a moderate to strong inactivator of CYP3A4, which metabolizes up to 50% of marketed drugs. The inhibitory effect is mainly attributed to furanocoumarins present in the fruit, irreversibly inhibiting preferably intestinal CYP3…
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: Plasma and Cerebrospinal Fluid Population Pharmacokinetics of Vancomycin in Patients with External Ventricular Drain
Plasma and Cerebrospinal Fluid Population Pharmacokinetics of Vancomycin in Patients with External Ventricular Drain Open
Vancomycin is a commonly used antibacterial agent in patients with primary central nervous system (CNS) infection. This study aims to examine predictors of vancomycin penetration into cerebrospinal fluid (CSF) in patients with external ven…
View article: In vitro validation of an in vivo phenotyping drug cocktail for major drug transporters in humans
In vitro validation of an in vivo phenotyping drug cocktail for major drug transporters in humans Open
The inhibition of hOCT2 in vitro by sitagliptin is in agreement with the borderline inhibition of renal metformin elimination observed clinically, supporting a dose reduction of sitagliptin in the cocktail.
View article: Population Pharmacokinetics as a Tool to Reevaluate the Complex Disposition of Ethanol in the Fed and Fasted States
Population Pharmacokinetics as a Tool to Reevaluate the Complex Disposition of Ethanol in the Fed and Fasted States Open
The pharmacokinetics (PK) of ethanol are important in pharmacology and therapeutics because of potential drug‐alcohol interactions as well as in forensic science when alcohol‐related crimes are investigated. The PK of ethanol have been ext…
View article: BTZ-043 Shows Good Safety and Strong Bactericidal Activity in a Combined Phase1b/2a Study in Tuberculosis Patients
BTZ-043 Shows Good Safety and Strong Bactericidal Activity in a Combined Phase1b/2a Study in Tuberculosis Patients Open
View article: A population pharmacokinetic model for creatinine with and without ingestion of a cooked meat meal
A population pharmacokinetic model for creatinine with and without ingestion of a cooked meat meal Open
View article: A population pharmacokinetic model of remdesivir and its major metabolites based on published mean values from healthy subjects
A population pharmacokinetic model of remdesivir and its major metabolites based on published mean values from healthy subjects Open
View article: A population pharmacokinetic model for creatinine with and without ingestion of a cooked meat meal
A population pharmacokinetic model for creatinine with and without ingestion of a cooked meat meal Open
A population pharmacokinetic (PPK) model for creatinine was successfully developed using creatinine concentration data from 6 healthy male volunteers with and without ingestion of 225 g boiled beef as an exogenous creatinine source. A mode…
View article: Pharmacokinetics of metronomic temozolomide in cerebrospinal fluid of children with malignant central nervous system tumors
Pharmacokinetics of metronomic temozolomide in cerebrospinal fluid of children with malignant central nervous system tumors Open
Purpose Although temozolomide is widely used in the treatment of childhood central nervous system (CNS) tumors, information on its pharmacokinetic profile in the brain or cerebrospinal fluid (CSF) is sparse. This study aimed at investigati…
View article: Physiologically‐based pharmacokinetic modeling of dextromethorphan to investigate interindividual variability within CYP2D6 activity score groups
Physiologically‐based pharmacokinetic modeling of dextromethorphan to investigate interindividual variability within CYP2D6 activity score groups Open
This study provides a whole‐body physiologically‐based pharmacokinetic (PBPK) model of dextromethorphan and its metabolites dextrorphan and dextrorphan O ‐glucuronide for predicting the effects of cytochrome P450 2D6 (CYP2D6) drug‐gene int…
View article: Developing a Nationwide Infrastructure for Therapeutic Drug Monitoring of Targeted Oral Anticancer Drugs: The ON-TARGET Study Protocol
Developing a Nationwide Infrastructure for Therapeutic Drug Monitoring of Targeted Oral Anticancer Drugs: The ON-TARGET Study Protocol Open
Exposure-efficacy and/or exposure-toxicity relationships have been identified for up to 80% of oral anticancer drugs (OADs). Usually, OADs are administered at fixed doses despite their high interindividual pharmacokinetic variability resul…
View article: Advancement of pharmacokinetic models of iohexol in patients aged 70 years or older with impaired kidney function
Advancement of pharmacokinetic models of iohexol in patients aged 70 years or older with impaired kidney function Open
View article: Clinical Pharmacokinetics and Pharmacodynamics of Cefiderocol
Clinical Pharmacokinetics and Pharmacodynamics of Cefiderocol Open
Cefiderocol is a new broad-spectrum cephalosporin antibiotic with promising activity against various Gram-negative bacteria including carbapenem-resistant strains. A chlorocatechol group in the C-3 side chain provides cefiderocol with a si…
View article: Evaluation of body-surface-area adjusted dosing of high-dose methotrexate by population pharmacokinetics in a large cohort of cancer patients
Evaluation of body-surface-area adjusted dosing of high-dose methotrexate by population pharmacokinetics in a large cohort of cancer patients Open
View article: A Model‐Based Approach to Assess Unstable Creatinine Clearance in Critically Ill Patients
A Model‐Based Approach to Assess Unstable Creatinine Clearance in Critically Ill Patients Open
Creatinine clearance is an important tool to describe the renal elimination of drugs in pharmacokinetic (PK) evaluations and clinical practice. In critically ill patients, unstable kidney function invalidates the steady‐state assumption un…
View article: A Population Pharmacokinetic Model of (R)‐ and (S‐) Oxybutynin and Its Active Metabolites After Oral and Intravesical Administration to Healthy Volunteers
A Population Pharmacokinetic Model of (R)‐ and (S‐) Oxybutynin and Its Active Metabolites After Oral and Intravesical Administration to Healthy Volunteers Open
Oxybutynin is a racemic anticholinergic drug used for the symptomatic treatment of detrusor overactivity. The formation of active metabolites related to tolerability problems depends on the route of administration. The objective of this ev…
View article: Pharmacokinetics of remdesivir in a COVID-19 patient with end-stage renal disease on intermittent haemodialysis
Pharmacokinetics of remdesivir in a COVID-19 patient with end-stage renal disease on intermittent haemodialysis Open
View article: Pharmacokinetics of remdesivir in a COVID-19 patient with end-stage renal disease on intermittent hemodialysis
Pharmacokinetics of remdesivir in a COVID-19 patient with end-stage renal disease on intermittent hemodialysis Open
Remdesivir, a drug with provisional approval for the treatment of COVID-19, is not recommended in patients with an estimated glomerular filtration rate ≤ 30 mL/min. Here we provide a first detailed pharmacokinetic assessment of remdesivir …