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Clinical Pharmacokinetics and Pharmacodynamics of CSL112
Clinical Pharmacokinetics and Pharmacodynamics of CSL112
Cardiovascular diseases are the leading cause of death worldwide. Although there have been substantial advances over the l...
Clearance as an Early Indicator of Efficacy for Therapeutic Monoclonal Antibodies: Circumventing Dose Selection Challenges in Oncology
Clearance as an Early Indicator of Efficacy for Therapeutic Monoclonal Antibodies: Circumventing Dose Selection Challenges in Oncology
The designs of first-in-human (FIH) studies in oncology (e.g., 3 + 3 dose escalation design) usually do ...
Effect of Various Dosing Schedules on the Pharmacokinetics of Oral Semaglutide: A Randomised Trial in Healthy Subjects
Effect of Various Dosing Schedules on the Pharmacokinetics of Oral Semaglutide: A Randomised Trial in Healthy Subjects
Prescribing information instructs taking oral semaglutide (a glucagon-like peptide-1 analogue) in the fasting state, follo...
The Pharmacokinetics and Target Attainment of Antimicrobial Drugs Throughout Pregnancy: Part III Non-penicillin and Non-cephalosporin Drugs
The Pharmacokinetics and Target Attainment of Antimicrobial Drugs Throughout Pregnancy: Part III Non-penicillin and Non-cephalosporin Drugs
Understanding the pharmacokinetics (PK) of antimicrobial drugs in pregnant women is crucial to provide effective and safe ...
Evaluation of the Potential for Cytochrome P450 and Transporter-Mediated Drug-Drug Interactions for Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor (FXR) Agonist
Evaluation of the Potential for Cytochrome P450 and Transporter-Mediated Drug-Drug Interactions for Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor (FXR) Agonist
Cilofexor is a selective farnesoid X receptor (FXR) agonist in development for the treatment of nonalcoholic steatohepatit...
Correction to: Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment
Correction to: Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International L...
Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn’s Disease and Ulcerative Colitis
Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn’s Disease and Ulcerative Colitis
Predicting adalimumab pharmacokinetics (PK) for patients impacted by anti-drug antibodies (ADA) has been challenging. The ...
Evaluation of CYP2C19-Mediated Pharmacokinetic Drug Interaction of Tegoprazan, Compared with Vonoprazan or Esomeprazole
Evaluation of CYP2C19-Mediated Pharmacokinetic Drug Interaction of Tegoprazan, Compared with Vonoprazan or Esomeprazole
CYP2C19-mediated drug interactions of acid-reducing agents are clinically important given the high possibility of concomit...
Population Pharmacokinetics and Exposure–Response Analysis for the Phase 3 COSMIC-311 Trial of Cabozantinib for Radioiodine-Refractory Differentiated Thyroid Cancer
Population Pharmacokinetics and Exposure–Response Analysis for the Phase 3 COSMIC-311 Trial of Cabozantinib for Radioiodine-Refractory Differentiated Thyroid Cancer
In the USA, cabozantinib was approved for the treatment of patients aged ≥ 12 years with radioiodine-refrac...
Alternative Methods for Therapeutic Drug Monitoring and Dose Adjustment of Tuberculosis Treatment in Clinical Settings: A Systematic Review
Alternative Methods for Therapeutic Drug Monitoring and Dose Adjustment of Tuberculosis Treatment in Clinical Settings: A Systematic Review
Quantifying exposure to drugs for personalized dose adjustment is of critical importance in patients with tuberculosis who...
Population Pharmacokinetics and Dosing Simulations of Ampicillin and Sulbactam in Hospitalised Adult Patients
Population Pharmacokinetics and Dosing Simulations of Ampicillin and Sulbactam in Hospitalised Adult Patients
The pharmacokinetic variability of ampicillin-sulbactam in adults has not been extensively described, particularly in pati...
Insights into the Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants in Older Adults with Atrial Fibrillation: A Structured Narrative Review
Insights into the Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants in Older Adults with Atrial Fibrillation: A Structured Narrative Review
Older adults, the fastest growing population, represent almost 50% of all users of direct oral anticoagulants (DOACs). Unf...
Clinical Evidence on the Purported Pharmacokinetic Interactions between Corticosteroids and Mycophenolic Acid
Clinical Evidence on the Purported Pharmacokinetic Interactions between Corticosteroids and Mycophenolic Acid
Corticosteroids (steroids) are commonly used concurrently with mycophenolic acid (MPA) as the first-line immunosuppression...
Predictions of Bedaquiline and Pretomanid Target Attainment in Lung Lesions of Tuberculosis Patients using Translational Minimal Physiologically Based Pharmacokinetic Modeling
Predictions of Bedaquiline and Pretomanid Target Attainment in Lung Lesions of Tuberculosis Patients using Translational Minimal Physiologically Based Pharmacokinetic Modeling
Site-of-action concentrations for bedaquiline and pretomanid from tuberculosis patients are unavailable. The objective of ...
Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment
Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment
Glepaglutide is a novel, ready-to-use, long-acting, glucagon-like peptide-2 (GLP-2) analog intended for the treatment of p...
A Model-Informed Approach to Accelerate the Clinical Development of Janagliflozin, an Innovative SGLT2 Inhibitor
A Model-Informed Approach to Accelerate the Clinical Development of Janagliflozin, an Innovative SGLT2 Inhibitor
To apply model-informed drug development (MIDD) approach to support the decision making in drug development and accelerate...
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials
Renal impairment is common in patients with cancer and can alter the PK and thus the safety and efficacy of drugs. We asse...
Determination of the Optimal Single Dose Treatment for Acoziborole, a Novel Drug for the Treatment of Human African Trypanosomiasis: First-in-Human Study
Determination of the Optimal Single Dose Treatment for Acoziborole, a Novel Drug for the Treatment of Human African Trypanosomiasis: First-in-Human Study
Acoziborole is a novel boron-containing candidate developed as an oral drug for the treatment of human African trypanosomi...
Correction to: Population Pharmacokinetics of Levosimendan and its Metabolites in Critically Ill Neonates and Children Supported or Not by Extracorporeal Membrane Oxygenation
Correction to: Population Pharmacokinetics of Levosimendan and its Metabolites in Critically Ill Neonates and Children Supported or Not by Extracorporeal Membrane Oxygenation
Pediatric Intensive Care Unit, CHU Nantes, 44093, Nantes, FrancePierre Bourgoin, Nicolas Joram & Alexis ChenouardDepar...
Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?
Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?
Mechanistic static and dynamic physiologically based pharmacokinetic models are used in clinical drug development to asses...
Pharmacokinetic Alterations Associated with Critical Illness
Pharmacokinetic Alterations Associated with Critical Illness
Haemodynamic, metabolic, and biochemical derangements in critically ill patients affect drug pharmacokinetics and pharmaco...
Evaluation of the Influence of Sildenafil on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vericiguat in Healthy Adults
Evaluation of the Influence of Sildenafil on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vericiguat in Healthy Adults
Vericiguat is approved for the treatment of patients with heart failure with ejection fraction < 45%. Sildenafil, i...
The Effect of BMI on Pharmacokinetic and Pharmacodynamic Parameters of Insulin Degludec: Results from an Euglycemic Glucose Clamp Study
The Effect of BMI on Pharmacokinetic and Pharmacodynamic Parameters of Insulin Degludec: Results from an Euglycemic Glucose Clamp Study
This study evaluated the effect of body mass index (BMI) on pharmacokinetic (PK) and pharmacodynamic (PD) parameters of in...
Integrated Pharmacokinetics/Pharmacodynamics Model and Simulation of the Ticagrelor Effect on Patients with Acute Coronary Syndrome
Integrated Pharmacokinetics/Pharmacodynamics Model and Simulation of the Ticagrelor Effect on Patients with Acute Coronary Syndrome
Data available for pharmacokinetics (PK)/pharmacodynamics (PD) of ticagrelor and significant endogenous/exogenous factors ...
Pharmacokinetics and Target Attainment of Antimicrobial Drugs Throughout Pregnancy: Part I—Penicillins
Pharmacokinetics and Target Attainment of Antimicrobial Drugs Throughout Pregnancy: Part I—Penicillins
Pharmacokinetics (PK) are severely altered in pregnant women due to changes in volume of distribution (Vd) and/or drug cle...
Development of an Intrauterine Device Releasing Both Indomethacin and Levonorgestrel During the First Months of Use: Pharmacokinetic Characterization in Healthy Women
Development of an Intrauterine Device Releasing Both Indomethacin and Levonorgestrel During the First Months of Use: Pharmacokinetic Characterization in Healthy Women
Post-placement menstrual bleeding pattern changes with intrauterine contraceptives (IUCs), including levonorgestrel-releas...
Population Pharmacokinetic Analysis of the RNAi Therapeutic Givosiran in Patients with Acute Hepatic Porphyria
Population Pharmacokinetic Analysis of the RNAi Therapeutic Givosiran in Patients with Acute Hepatic Porphyria
Givosiran, approved for the treatment of acute hepatic porphyria (AHP), is the first subcutaneously administered RNAi ther...
Evaluation of Renal Impairment Influence on Metabolic Drug Clearance using a Modelling Approach
Evaluation of Renal Impairment Influence on Metabolic Drug Clearance using a Modelling Approach
Chronic kidney disease (CKD) may alter drug renal elimination but is also known for interacting with hepatic metabolism vi...
Considering the Oral Bioavailability of Protein Kinase Inhibitors: Essential in Assessing the Extent of Drug–Drug Interaction and Improving Clinical Practice
Considering the Oral Bioavailability of Protein Kinase Inhibitors: Essential in Assessing the Extent of Drug–Drug Interaction and Improving Clinical Practice
Protein kinase inhibitors share pharmacokinetic (PK) pathways among themselves. They are all metabolized by several cytoch...
Population Pharmacokinetics of Levosimendan and its Metabolites in Critically Ill Neonates and Children Supported or Not by Extracorporeal Membrane Oxygenation
Population Pharmacokinetics of Levosimendan and its Metabolites in Critically Ill Neonates and Children Supported or Not by Extracorporeal Membrane Oxygenation
Levosimendan (LVSMD) is a calcium-sensitizer inotropic and vasodilator agent whose use might have a beneficial effect on t...
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