Matthew L. Rizk
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View article: <scp>ASCPT</scp> 125th Anniversary: A Society Leadership Perspective
<span>ASCPT</span> 125th Anniversary: A Society Leadership Perspective Open
The 125th anniversary of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) marks a significant milestone, providing an opportunity to reflect on the Society's rich history and pivotal role in advancing science, educat…
View article: Comparison of Molnupiravir Exposure‐Response Relationships for Virology Response and Mechanism of Action Biomarkers With Clinical Outcomes in Treatment of <scp>COVID</scp>‐19
Comparison of Molnupiravir Exposure‐Response Relationships for Virology Response and Mechanism of Action Biomarkers With Clinical Outcomes in Treatment of <span>COVID</span>‐19 Open
Molnupiravir, an orally administered drug for the treatment of mild‐to‐moderate COVID‐19, is a prodrug of the ribonucleoside β‐D‐N4‐hydroxycytidine (NHC). NHC incorporation in the SARS‐CoV‐2 RNA strand causes an accumulation of deleterious…
View article: Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study
Impact of differences between interim and post-interim analysis populations on outcomes of a group sequential trial: Example of the MOVe-OUT study Open
Background Pre-specified interim analyses allow for more timely evaluation of efficacy or futility, potentially accelerating decision-making on an investigational intervention. In such an analysis, the randomized, double-blind MOVe-OUT tri…
View article: Clinical Trial: A Phase 2b Study to Evaluate the Efficacy and Safety of MK‐3655 in Individuals With Pre‐Cirrhotic MASH
Clinical Trial: A Phase 2b Study to Evaluate the Efficacy and Safety of MK‐3655 in Individuals With Pre‐Cirrhotic MASH Open
Background Fibroblast growth factor 21 (FGF21) is a metabolic regulator with demonstrated efficacy for the treatment of metabolic dysfunction‐associated steatohepatitis (MASH). FGF21 signals through ‘c’ isoforms of the FGF receptors (FGFR)…
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Clinical and Translational Science highlights original research that helps bridge laboratory discovery with the diagnosis and treatment of human disease.Research may appear as Articles, Commentaries, Point-Counterpoint, Phase Forwards, Rev…
View article: Molnupiravir: Mechanism of action, clinical, and translational science
Molnupiravir: Mechanism of action, clinical, and translational science Open
Molnupiravir is an oral prodrug of the broadly active, antiviral ribonucleoside analog N ‐hydroxycytidine (NHC). The primary circulating metabolite NHC is taken up into cells and phosphorylated to NHC‐triphosphate (NHC‐TP). NHC‐TP serves a…
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Clinical and Translational Science highlights original research that helps bridge laboratory discovery with the diagnosis and treatment of human disease.Research may appear as Articles, Commentaries, Point-Counterpoint, Phase Forwards, Rev…
View article: Issue Information
Issue Information Open
Clinical and Translational Science highlights original research that helps bridge laboratory discovery with the diagnosis and treatment of human disease. Research may appear as Articles
View article: Population pharmacokinetics of molnupiravir in adults with <scp>COVID</scp>‐19: Lack of clinically important exposure variation across individuals
Population pharmacokinetics of molnupiravir in adults with <span>COVID</span>‐19: Lack of clinically important exposure variation across individuals Open
Effective antiviral treatments for coronavirus disease 2019 (COVID‐19) are needed to reduce the morbidity and mortality associated with severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) infection, particularly in patients with r…
View article: Factors Influencing <scp>COVID</scp>‐19 Risk: Insights From Molnupiravir <scp>Exposure‐Response</scp> Modeling of Clinical Outcomes
Factors Influencing <span>COVID</span>‐19 Risk: Insights From Molnupiravir <span>Exposure‐Response</span> Modeling of Clinical Outcomes Open
Molnupiravir (MOV) is an oral antiviral for the treatment of coronavirus disease 2019 (COVID‐19) in outpatient settings. This analysis investigated the relationship between β‐D‐N4‐hydroxycytidine (NHC) pharmacokinetics and clinical outcome…
View article: Imipenem/cilastatin/relebactam efficacy, safety and probability of target attainment in adults with hospital-acquired or ventilator-associated bacterial pneumonia among patients with baseline renal impairment, normal renal function, and augmented renal clearance
Imipenem/cilastatin/relebactam efficacy, safety and probability of target attainment in adults with hospital-acquired or ventilator-associated bacterial pneumonia among patients with baseline renal impairment, normal renal function, and augmented renal clearance Open
Objectives To assess the relationship between renal function and efficacy/safety of imipenem/cilastatin/relebactam for the treatment of hospital-acquired/ventilator-associated pneumonia (HABP/VABP) from RESTORE-IMI 2 and determine the PTA.…
View article: Population pharmacokinetic/pharmacodynamic assessment of imipenem/cilastatin/relebactam in patients with hospital‐acquired/ventilator‐associated bacterial pneumonia
Population pharmacokinetic/pharmacodynamic assessment of imipenem/cilastatin/relebactam in patients with hospital‐acquired/ventilator‐associated bacterial pneumonia Open
In the phase III RESTORE‐IMI 2 study (ClinicalTrials.gov: NCT02493764), the combination antibacterial agent imipenem/cilastatin/relebactam (IMI/REL) demonstrated noninferiority to piperacillin/tazobactam for the end points of all‐cause mor…
View article: Understanding effect site pharmacology of uprifosbuvir, a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development
Understanding effect site pharmacology of uprifosbuvir, a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development Open
Uprifosbuvir is a uridine nucleoside monophosphate prodrug inhibitor of the hepatitis C virus NS5B RNA polymerase. To quantitatively elucidate key metabolic pathways, assess the link between unmeasurable effect site concentrations and vira…
View article: Pharmacokinetics and Pharmacodynamics of Once-Daily versus Twice-Daily Raltegravir in Treatment-Naïve HIV-Infected Patients
Pharmacokinetics and Pharmacodynamics of Once-Daily versus Twice-Daily Raltegravir in Treatment-Naïve HIV-Infected Patients Open
QDMRK was a phase III clinical trial of raltegravir given once daily (QD) (800-mg dose) versus twice daily (BID) (400 mg per dose), each in combination with once-daily coformulated tenofovir-emtricitabine, in treatment-naive HIV-infected p…
View article: In Vitro Hollow-Fiber Studies Assessing Antibacterial Activity of Ceftolozane/Tazobactam Against Multidrug-Resistant <i>Pseudomonas Aeruginosa</i>
In Vitro Hollow-Fiber Studies Assessing Antibacterial Activity of Ceftolozane/Tazobactam Against Multidrug-Resistant <i>Pseudomonas Aeruginosa</i> Open
Our hollow-fiber infection model simulated the projected steady-state pharmacokinetics of ceftolozane and tazobactam in lung epithelial lining fluid of patients with pneumonia receiving 3 g of ceftolozane/tazobactam every 8 hours. Results …
View article: Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID‐19 Infection
Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID‐19 Infection Open
Chloroquine and hydroxychloroquine are quinoline derivatives used to treat malaria. To date, these medications are not approved for the treatment of viral infections, and there are no well‐controlled, prospective, randomized clinical studi…
View article: A Randomized, Double-blind, Multicenter Trial Comparing Efficacy and Safety of Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam in Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study)
A Randomized, Double-blind, Multicenter Trial Comparing Efficacy and Safety of Imipenem/Cilastatin/Relebactam Versus Piperacillin/Tazobactam in Adults With Hospital-acquired or Ventilator-associated Bacterial Pneumonia (RESTORE-IMI 2 Study) Open
Background Imipenem combined with the β-lactamase inhibitor relebactam has broad antibacterial activity, including against carbapenem-resistant gram-negative pathogens. We evaluated efficacy and safety of imipenem/cilastatin/relebactam in …
View article: OP0018 A MULTICENTER RANDOMIZED STUDY IN EARLY RHEUMATOID ARTHRITIS TO COMPARE ACTIVE CONVENTIONAL THERAPY VERSUS THREE BIOLOGICAL TREATMENTS: 24 WEEK EFFICACY RESULTS OF THE NORD-STAR TRIAL
OP0018 A MULTICENTER RANDOMIZED STUDY IN EARLY RHEUMATOID ARTHRITIS TO COMPARE ACTIVE CONVENTIONAL THERAPY VERSUS THREE BIOLOGICAL TREATMENTS: 24 WEEK EFFICACY RESULTS OF THE NORD-STAR TRIAL Open
View article: Impact of renal impairment and human organic anion transporter inhibition on pharmacokinetics, safety and tolerability of relebactam combined with imipenem and cilastatin
Impact of renal impairment and human organic anion transporter inhibition on pharmacokinetics, safety and tolerability of relebactam combined with imipenem and cilastatin Open
Aims Two phase 1, open‐label studies were conducted to investigate the effect of renal impairment (RI) and organic anion transporter (OAT) inhibition on pharmacokinetics (PK) and safety of relebactam (REL) plus imipenem/cilastatin (IMI). M…
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View article: Population Pharmacokinetic Analysis for Imipenem–Relebactam in Healthy Volunteers and Patients With Bacterial Infections
Population Pharmacokinetic Analysis for Imipenem–Relebactam in Healthy Volunteers and Patients With Bacterial Infections Open
Relebactam is a small‐molecule β‐lactamase inhibitor developed as a fixed‐dose combination with imipenem/cilastatin. The pharmacokinetics of relebactam and imipenem across 10 clinical studies were analyzed using data from adult healthy vol…
View article: A translational pharmacokinetic/pharmacodynamic model to characterize bacterial kill in the presence of imipenem-relebactam
A translational pharmacokinetic/pharmacodynamic model to characterize bacterial kill in the presence of imipenem-relebactam Open
View article: Ceftolozane-Tazobactam Population Pharmacokinetics and Dose Selection for Further Clinical Evaluation in Pediatric Patients with Complicated Urinary Tract or Complicated Intra-abdominal Infections
Ceftolozane-Tazobactam Population Pharmacokinetics and Dose Selection for Further Clinical Evaluation in Pediatric Patients with Complicated Urinary Tract or Complicated Intra-abdominal Infections Open
Ceftolozane-tazobactam, a combination of the novel antipseudomonal cephalosporin ceftolozane and the well-established extended-spectrum β-lactamase inhibitor tazobactam, is approved for treating complicated urinary tract infections (cUTI) …
View article: Considerations for Dose Selection and Clinical Pharmacokinetics/Pharmacodynamics for the Development of Antibacterial Agents
Considerations for Dose Selection and Clinical Pharmacokinetics/Pharmacodynamics for the Development of Antibacterial Agents Open
In June 2017, The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, organized a workshop entitled “Pharmacokinetics-Pharmacodynamics (PK/PD) for Development of Therapeutics against Bacterial …
View article: Population pharmacokinetics of tazobactam/ceftolozane in Japanese patients with complicated urinary tract infection and complicated intra-abdominal infection
Population pharmacokinetics of tazobactam/ceftolozane in Japanese patients with complicated urinary tract infection and complicated intra-abdominal infection Open
Tazobactam/ceftolozane is a combination of a β-lactamase inhibitor and a cephalosporin antibiotic, with recommended dosage for patients with normal renal function of tazobactam 0.5 g/ceftolozane 1 g administered as a 1-h intravenous infusi…
View article: Erratum for Rhee et al., “Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Relebactam, a β-Lactamase Inhibitor, in Combination with Imipenem and Cilastatin in Healthy Participants”
Erratum for Rhee et al., “Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Relebactam, a β-Lactamase Inhibitor, in Combination with Imipenem and Cilastatin in Healthy Participants” Open
View article: Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Relebactam, a β-Lactamase Inhibitor, in Combination with Imipenem and Cilastatin in Healthy Participants
Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Relebactam, a β-Lactamase Inhibitor, in Combination with Imipenem and Cilastatin in Healthy Participants Open
Relebactam is a novel class A and C β-lactamase inhibitor that is being developed in combination with imipenem-cilastatin for the treatment of serious infections with Gram-negative bacteria. Here we report on two phase 1 randomized, double…
View article: Perspective on the State of Pharmacometrics and Systems Pharmacology Integration
Perspective on the State of Pharmacometrics and Systems Pharmacology Integration Open
Reliance on modeling and simulation in drug discovery and development has dramatically increased over the past decade. Two disciplines at the forefront of this activity, pharmacometrics and systems pharmacology (SP), emerged independently …
View article: Exploring the Pharmacokinetic/Pharmacodynamic Relationship of Relebactam (MK-7655) in Combination with Imipenem in a Hollow-Fiber Infection Model
Exploring the Pharmacokinetic/Pharmacodynamic Relationship of Relebactam (MK-7655) in Combination with Imipenem in a Hollow-Fiber Infection Model Open
Resistance to antibiotics among bacterial pathogens is rapidly spreading, and therapeutic options against multidrug-resistant bacteria are limited. There is an urgent need for new drugs, especially those that can circumvent the broad array…
View article: Validation of a Model Predicting Anti-infective Lung Penetration in the Epithelial Lining Fluid of Humans
Validation of a Model Predicting Anti-infective Lung Penetration in the Epithelial Lining Fluid of Humans Open