Kevin Sweeney
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View article: Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis
Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis Open
Brepocitinib is an oral selective dual TYK2/JAK1 inhibitor and based on its cytokine inhibition profile is expected to provide therapeutic benefit in the treatment of plaque psoriasis. Efficacy data from a completed Phase 2a study in patie…
View article: Population PK/PD modeling of low‐density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent <scp>anti‐PCSK9</scp> monoclonal antibody
Population PK/PD modeling of low‐density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent <span>anti‐PCSK9</span> monoclonal antibody Open
We sought to characterize the population pharmacokinetic/pharmacodynamic (PK/PD) relationship of bococizumab (RN316/PF‐04950615), a humanized IgG2Δa monoclonal antibody that binds to secreted human proprotein convertase subtilisin kexin ty…
View article: Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity
Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity Open
View article: Improving Leadership in Family Medicine Residents : Development of a Workshop and a Field Note
Improving Leadership in Family Medicine Residents : Development of a Workshop and a Field Note Open
CONTEXT: Although the CanMEDS include a leader role, specific leadership competency training is lacking in family medicine residency in Quebec and Canada. OBJECTIVE: To increase the awareness about the leadership competency in family medic…
View article: Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations
Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations Open
Ertugliflozin, a sodium‐glucose cotransporter 2 inhibitor, is approved for treatment of type 2 diabetes. Two population pharmacokinetic (PK) analyses were conducted, using data from up to 17 phase 1 to 3 studies, to characterize ertugliflo…
View article: Population pharmacokinetics and exposure–response analyses of varenicline in adolescent smokers
Population pharmacokinetics and exposure–response analyses of varenicline in adolescent smokers Open
Varenicline is an approved smoking cessation aid in adults. Population pharmacokinetics (popPK) and exposure–response (ER) (continuous abstinence rates [CAR] weeks 9‒12 and nausea/vomiting incidence) for varenicline in adolescent smokers w…
View article: End‐to‐end application of model‐informed drug development for ertugliflozin, a novel sodium‐glucose cotransporter 2 inhibitor
End‐to‐end application of model‐informed drug development for ertugliflozin, a novel sodium‐glucose cotransporter 2 inhibitor Open
Model‐informed drug development (MIDD) is critical in all stages of the drug‐development process and almost all regulatory submissions for new agents incorporate some form of modeling and simulation. This review describes the MIDD approach…
View article: Meta‐Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and <i>UGT1A9</i> Polymorphism Effect on Exposure
Meta‐Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and <i>UGT1A9</i> Polymorphism Effect on Exposure Open
Ertugliflozin, a sodium‐glucose cotransporter 2 inhibitor, is primarily metabolized via glucuronidation by the uridine 5′‐diphospho‐glucuronosyltransferase (UGT) isoform UGT1A9. This noncompartmental meta‐analysis of ertugliflozin pharmaco…
View article: Population Pharmacokinetic Model for Ertugliflozin in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Population Pharmacokinetic Model for Ertugliflozin in Healthy Subjects and Patients With Type 2 Diabetes Mellitus Open
Ertugliflozin is a selective sodium‐glucose cotransporter 2 inhibitor approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). A population pharmacokinetic (popPK) model was de…
View article: Population Pharmacokinetic Analysis of Dalteparin in Pediatric Patients With Venous Thromboembolism
Population Pharmacokinetic Analysis of Dalteparin in Pediatric Patients With Venous Thromboembolism Open
This article describes the population pharmacokinetics (PK) of dalteparin in pediatric patients with venous thromboembolism (VTE). A prospective multicenter open‐label study was conducted in children who required anticoagulation for the tr…
View article: Predictions of Systemic, Intracellular, and Lung Concentrations of Azithromycin With Different Dosing Regimens Used in COVID‐19 Clinical Trials
Predictions of Systemic, Intracellular, and Lung Concentrations of Azithromycin With Different Dosing Regimens Used in COVID‐19 Clinical Trials Open
Azithromycin (AZ), a broad‐spectrum macrolide antibiotic, is being investigated in patients with coronavirus disease 2019 (COVID‐19). A population pharmacokinetic model was implemented to predict lung, intracellular poly/mononuclear cell (…
View article: The Privileged Physician and Medical Malpractice: Why a Qualified Expert Testimonial Privilege Should Not Apply to Defendant Treating Health Care Providers
The Privileged Physician and Medical Malpractice: Why a Qualified Expert Testimonial Privilege Should Not Apply to Defendant Treating Health Care Providers Open
In Redding Life Care, LLC v. Town of Redding, the Connecticut Appellate Court recognized a qualified expert testimonial privilege that precludes discovery of an unretained expert’s opinion. That decision threatens to eliminate relevant and…
View article: Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin®) in patients with advanced non-squamous non-small cell lung cancer
Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin®) in patients with advanced non-squamous non-small cell lung cancer Open
Purpose The objectives of this analysis were to characterize the population pharmacokinetics (PK) of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin ® ) sourced from the European Union (bevacizumab-EU) in patients…
View article: Population Pharmacokinetics, Pharmacodynamics, and Exploratory Exposure–Response Analyses of Apixaban in Subjects Treated for Venous Thromboembolism
Population Pharmacokinetics, Pharmacodynamics, and Exploratory Exposure–Response Analyses of Apixaban in Subjects Treated for Venous Thromboembolism Open
Apixaban is approved for treatment of venous thromboembolism (VTE) and prevention of recurrence. Population pharmacokinetics, pharmacokinetics–pharmacodynamics (anti‐FXa activity), and exposure–response (binary bleeding and thromboembolic …
View article: Does the Systemic Plasma Profile Inform the Liver Profile? Analysis Using a Physiologically Based Pharmacokinetic Model and Individual Compounds
Does the Systemic Plasma Profile Inform the Liver Profile? Analysis Using a Physiologically Based Pharmacokinetic Model and Individual Compounds Open
View article: Results of Bococizumab, A Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, from a Randomized, Placebo-Controlled, Dose-Ranging Study in Statin-Treated Subjects With Hypercholesterolemia
Results of Bococizumab, A Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, from a Randomized, Placebo-Controlled, Dose-Ranging Study in Statin-Treated Subjects With Hypercholesterolemia Open