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Analysis of US Food and Drug Administration Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations
Analysis of US Food and Drug Administration Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations
Patients with cancer and advanced hepatic impairment (HI) (i.e., moderate and severe impairment) are often excluded from f...
De‐risking Clinical Trials: The BIAL Phase I Trial in Foresight
De‐risking Clinical Trials: The BIAL Phase I Trial in Foresight
Disasters in early drug development are rare but, because they generally harm healthy young people, remembered for a long ...
Machine Learning Application in a Phase I Clinical Trial Allows for the Identification of Clinical‐Biomolecular Markers Significantly Associated with Toxicity
Machine Learning Application in a Phase I Clinical Trial Allows for the Identification of Clinical‐Biomolecular Markers Significantly Associated with Toxicity
Machine learning (ML) algorithms have been used to forecast clinical outcomes or drug adverse effects by analyzing differe...
Family Driven Development of Treatments for Rare Pediatric Neurological Diseases
Family Driven Development of Treatments for Rare Pediatric Neurological Diseases
Please check your email for instructions on resetting your password. If you do not r...
Association of Vitamin K and Non‐Vitamin K Oral Anticoagulant Use and Cancer Incidence in Atrial Fibrillation Patients
Association of Vitamin K and Non‐Vitamin K Oral Anticoagulant Use and Cancer Incidence in Atrial Fibrillation Patients
The association between the use of vitamin K antagonists (VKAs) and cancer risk reduction remains unclear. We aimed to ass...
Probability of Success: A Crucial Concept to Inform Decision Making in Pharmaceutical Research and Development
Probability of Success: A Crucial Concept to Inform Decision Making in Pharmaceutical Research and Development
Early View Commentary Richard L. Lalonde, Corresponding Author Richard...
A systematic review and analysis of the use of polygenic scores in pharmacogenomics
A systematic review and analysis of the use of polygenic scores in pharmacogenomics
Abstract Polygenic scores (PGS) have emerged as promising tools for complex trait risk prediction. The application of thes...
Innovative Pediatric Development for Secukinumab in Psoriasis: Faster Patient Access, Reduction of Patients on Control
Innovative Pediatric Development for Secukinumab in Psoriasis: Faster Patient Access, Reduction of Patients on Control
ABSTRACT This manuscript describes the innovative pediatric development strategy of secukinumab in psoriasis. Initially, t...
Serotonin‐affecting antidepressant use in relation to platelet reactivity
Serotonin‐affecting antidepressant use in relation to platelet reactivity
Abstract Depression is an independent risk factor of cardiovascular disease morbidity. Serotonin is a key neurotransmitter...
Clinical, cellular and molecular effects of corticosteroids on the response to intradermal lipopolysaccharide administration in healthy volunteers
Clinical, cellular and molecular effects of corticosteroids on the response to intradermal lipopolysaccharide administration in healthy volunteers
Abstract The intradermal LPS challenge in healthy volunteers has proven to be a valuable tool to study local inflammation ...
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?
Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence?
Information derived from routinely collected real-world data has for a long time been used to support regulatory decision ...
When Can We Rely on Real‐World Evidence to Evaluate New Medical Treatments?
When Can We Rely on Real‐World Evidence to Evaluate New Medical Treatments?
Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls ...
When Can We Trust Real‐World Data To Evaluate New Medical Treatments?
When Can We Trust Real‐World Data To Evaluate New Medical Treatments?
Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls ...
When Are Treatment Blinding and Treatment Standardization Necessary in Real‐World Clinical Trials?
When Are Treatment Blinding and Treatment Standardization Necessary in Real‐World Clinical Trials?
Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls ...
Liver Injury Due to Drugs and Viruses: Mechanistic Similarities and Implications for AAV Gene Therapy
Liver Injury Due to Drugs and Viruses: Mechanistic Similarities and Implications for AAV Gene Therapy
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Mechanistic Modelling of Primaquine Pharmacokinetics, Gametocytocidal Activity, and Mosquito Infectivity
Mechanistic Modelling of Primaquine Pharmacokinetics, Gametocytocidal Activity, and Mosquito Infectivity
Abstract Clinical studies have shown that adding a single 0.25mg base/kg dose of primaquine to standard antimalarial regim...
Machine Learning Application in a Phase I Clinical Trial Allows to Identify Clinical‐Biomolecular Markers Significantly Associated with Toxicity
Machine Learning Application in a Phase I Clinical Trial Allows to Identify Clinical‐Biomolecular Markers Significantly Associated with Toxicity
ABSTRACT Machine Learning (ML) algorithms have been used to forecast clinical outcomes or drug adverse effect by analysing...
Exogenous sex hormones and sex hormone receptor modulators in COVID‐19 ― rationale and clinical pharmacology considerations
Exogenous sex hormones and sex hormone receptor modulators in COVID‐19 ― rationale and clinical pharmacology considerations
Abstract Male patients with coronavirus disease 2019 (COVID-19) fare much worse than female patients in COVID-19 severity ...
Clinical Pharmacology Perspectives for Adoptive Cell Therapies in Oncology
Clinical Pharmacology Perspectives for Adoptive Cell Therapies in Oncology
Abstract Adoptive cell therapies (ACTs) have shown transformative efficacy in oncology with five FDA approvals for CAR T-c...
Acute and Chronic Effects of Rifampin on Letermovir Suggest Transporter Inhibition and Induction Contribute to Letermovir Pharmacokinetics
Acute and Chronic Effects of Rifampin on Letermovir Suggest Transporter Inhibition and Induction Contribute to Letermovir Pharmacokinetics
ABSTRACT Rifampin has acute inhibitory and chronic inductive effects that can cause complex drug–drug interactions....
Can In Vitro–In Vivo Extrapolation Be Successful? Recognizing the Incorrect Clearance Assumptions
Can In Vitro–In Vivo Extrapolation Be Successful? Recognizing the Incorrect Clearance Assumptions
For a number of years, our laboratory has been investigating the underlying reasons for the published poor in vitro–...
Effect of CYP3A5 and CYP3A4 Genetic Variants on Fentanyl Pharmacokinetics in a Pediatric Population
Effect of CYP3A5 and CYP3A4 Genetic Variants on Fentanyl Pharmacokinetics in a Pediatric Population
Abstract Fentanyl is an anesthetic/analgesic commonly used in surgical and recovery settings. CYP3A4 and CYP3A5 encode enz...
The PHARMACOM‐EPI framework for integrating pharmacometric modelling into pharmacoepidemiological research using real‐world data: application to assess death associated with valproate
The PHARMACOM‐EPI framework for integrating pharmacometric modelling into pharmacoepidemiological research using real‐world data: application to assess death associated with valproate
ABSTRACT In pharmacoepidemiology, it is usually expected that the observed association should be directly or indirectly re...
Features of inflammatory heart reactions following mRNA COVID‐19 vaccination at a global level
Features of inflammatory heart reactions following mRNA COVID‐19 vaccination at a global level
ABSTRACT Myocarditis and pericarditis may constitute adverse reactions of mRNA COVID-19 vaccines. This study aimed to docu...
Clinical Pharmacology in Drug Development for Rare Diseases in Neurology: Contributions and Opportunities
Clinical Pharmacology in Drug Development for Rare Diseases in Neurology: Contributions and Opportunities
Abstract Several challenges are associated with rare disease drug development in neurology. In this article, we summarize ...
Anticoagulant treatment regimens in patients with Covid‐19: a meta‐analysis
Anticoagulant treatment regimens in patients with Covid‐19: a meta‐analysis
Abstract Coronavirus disease 2019 (Covid-19) is associated with a hypercoagulable state. It has been hypothesized that hig...
Current Practices, Gap Analysis and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective
Current Practices, Gap Analysis and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective
Abstract The International Consortium for Innovation and Quality (IQ) Physiologically Based Pharmacokinetic modeling (PBPK...
Analysis of FDA Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations
Analysis of FDA Oncology Approvals on the Characterization of Hepatic Impairment Effect and Dosing Recommendations
Abstract Cancer patients with advanced hepatic impairment (HI) (ie, moderate and severe impairment) are often excluded fro...
The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework
The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework
To complement real-world evidence (RWE) guidelines, the 2019 Structured Preapproval and Postapproval Comparative study des...
Dose Optimization of Pembrolizumab: Less May Be More
Dose Optimization of Pembrolizumab: Less May Be More
Early View Letter to the Editor Mark J. Ratain, Corresponding Author S...
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