Munjal Patel
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View article: Use of <scp>PopPK</scp> and E‐R Analyses toward Explaining Causal Link Between <scp>ADAMTS13</scp> in Recombinant vs. Plasma‐Based Therapies and Clinical Effects in <scp>cTTP</scp>
Use of <span>PopPK</span> and E‐R Analyses toward Explaining Causal Link Between <span>ADAMTS13</span> in Recombinant vs. Plasma‐Based Therapies and Clinical Effects in <span>cTTP</span> Open
Congenital thrombotic thrombocytopenic purpura (cTTP) is an ultra‐rare, potentially life‐threatening condition caused by a deficiency of the blood enzyme ADAMTS13. Until now, ADAMTS13 replacement has been achieved with infusions of plasma …
View article: Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1
Safety, Tolerability, and Pharmacokinetics of Once-Monthly Oral Islatravir: A Phase 2a Study in Participants at Low Risk for Acquiring Human Immunodeficiency Virus Type 1 Open
Background Islatravir, a nucleoside reverse transcriptase translocation inhibitor, exhibits high potency against human immunodeficiency virus type 1 (HIV-1), with a long intracellular half-life. The safety, tolerability, and pharmacokineti…
View article: Brief Report: Exploratory Substudy of a Phase 2 Trial to Evaluate the Pharmacokinetic Effect of Once-Monthly Islatravir on Long-Acting Reversible Contraceptives
Brief Report: Exploratory Substudy of a Phase 2 Trial to Evaluate the Pharmacokinetic Effect of Once-Monthly Islatravir on Long-Acting Reversible Contraceptives Open
Background: People living with, or at risk of acquiring, HIV-1 may use hormonal long-acting reversible contraceptives (LARCs). Islatravir is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment of HIV…
View article: Pharmacokinetics of islatravir in participants with moderate hepatic impairment
Pharmacokinetics of islatravir in participants with moderate hepatic impairment Open
Islatravir (ISL) is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment of HIV-1 infection. People living with HIV are at risk of liver disease. ISL is metabolized by adenosine deaminase (ADA), which…
View article: Nonclinical and clinical characterization of the absorption, metabolism, and excretion of islatravir
Nonclinical and clinical characterization of the absorption, metabolism, and excretion of islatravir Open
The development of new and improved antiretroviral therapies that allow for alternative dosing schedules is needed for people living with HIV-1. Islatravir is a deoxyadenosine analog in development for the treatment of HIV-1 that suppresse…
View article: A Phase 1 Study to Evaluate the Pharmacokinetic Drug‐Drug Interaction Between Islatravir and Methadone in Participants on Stable Methadone Therapy
A Phase 1 Study to Evaluate the Pharmacokinetic Drug‐Drug Interaction Between Islatravir and Methadone in Participants on Stable Methadone Therapy Open
Islatravir is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment of HIV‐1. People living with HIV‐1 receiving methadone maintenance therapy may benefit from islatravir. This study was designed to ev…
View article: Pharmacokinetics of Atorvastatin and Metformin after Coadministration with Islatravir in Healthy Adults
Pharmacokinetics of Atorvastatin and Metformin after Coadministration with Islatravir in Healthy Adults Open
Islatravir, a deoxyadenosine analog that inhibits HIV‐1 replication by multiple mechanisms of action, including reverse transcriptase translocation inhibition, is being developed for use in HIV‐1 treatment. People living with HIV often hav…
View article: P2.17-07 Real-world Safety and Dosing of Lurbinectedin-Treated Patients with Small Cell Lung Cancer: Jazz EMERGE 402 Preliminary Analysis
P2.17-07 Real-world Safety and Dosing of Lurbinectedin-Treated Patients with Small Cell Lung Cancer: Jazz EMERGE 402 Preliminary Analysis Open
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: Safety and Pharmacokinetics of Islatravir in Individuals with Severe Renal Insufficiency
Safety and Pharmacokinetics of Islatravir in Individuals with Severe Renal Insufficiency Open
Islatravir (MK-8591) is a high-potency reverse transcriptase translocation inhibitor in development for the treatment of HIV-1 infection. Data from preclinical and clinical studies suggest that ~30% to 60% of islatravir is excreted renally…
View article: 1159. Pharmacokinetics, Safety, and Tolerability of Imipenem/Cilastatin/Relebactam in Pediatric Participants With Confirmed or Suspected Gram-negative Bacterial Infections: A Phase 1b, Open-label, Single-Dose Clinical Trial
1159. Pharmacokinetics, Safety, and Tolerability of Imipenem/Cilastatin/Relebactam in Pediatric Participants With Confirmed or Suspected Gram-negative Bacterial Infections: A Phase 1b, Open-label, Single-Dose Clinical Trial Open
Background Imipenem/cilastatin/relebactam (IMI/REL) is approved for treating hospital-acquired/ventilator-associated bacterial pneumonia, complicated urinary tract infection, and complicated intra-abdominal infection in adults. This study …
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: PREVALENCE OF HEPATITIS B AND C INFECTIONS AMONG HOSPITALIZED RESPIRATORY PATIENTS: A TERTIARY CARE ANALYSIS FROM MULLANA, HARYANA
PREVALENCE OF HEPATITIS B AND C INFECTIONS AMONG HOSPITALIZED RESPIRATORY PATIENTS: A TERTIARY CARE ANALYSIS FROM MULLANA, HARYANA Open
View article: In Vitro Pharmacokinetic/Pharmacodynamic Modeling of HIV Latency Reversal by Novel HDAC Inhibitors Using an Automated Platform
In Vitro Pharmacokinetic/Pharmacodynamic Modeling of HIV Latency Reversal by Novel HDAC Inhibitors Using an Automated Platform Open
Antiretroviral therapy is able to effectively control but not eradicate HIV infection, which can persist, leading to the need for lifelong therapy. The existence of latently HIV-infected cells is a major barrier to the eradication of chron…
View article: A Single- and Multiple-Dose Study To Characterize the Pharmacokinetics, Safety, and Tolerability of Imipenem and Relebactam in Healthy Chinese Participants
A Single- and Multiple-Dose Study To Characterize the Pharmacokinetics, Safety, and Tolerability of Imipenem and Relebactam in Healthy Chinese Participants Open
Relebactam/imipenem/cilastatin is approved in the United States to treat complicated urinary tract and intra-abdominal infections in patients who have limited or no alternative treatment options and hospital-acquired bacterial pneumonia (H…
View article: Predicting Clinical Outcomes of Patients with Stage III Non-Small-Cell Lung Cancer Treated with Concurrent Chemoradiation with and without PD-1/PD-L1 Inhibitors Using Cone Beam Computed Tomography
Predicting Clinical Outcomes of Patients with Stage III Non-Small-Cell Lung Cancer Treated with Concurrent Chemoradiation with and without PD-1/PD-L1 Inhibitors Using Cone Beam Computed Tomography Open
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: A phase I open label dose escalation trial evaluating VT1021 in patients with advanced solid tumours
A phase I open label dose escalation trial evaluating VT1021 in patients with advanced solid tumours Open