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pharmacokinetics

  • Open Access
    Safety and Pharmacokinetics of a Four Monoclonal Antibody Combination against Botulinum C and D Neurotoxins
    Clinical Therapeutics
    Safety and Pharmacokinetics of a Four Monoclonal Antibody Combination against Botulinum C and D Neurotoxins

    Botulism is caused by botulinum neurotoxin (BoNT), the most poisonous substance known. BoNTs are also classified as tier 1 biothreat agents due to their high potency and lethality. The existence of seven BoNT serotypes (A to G), which differ by 35% to 68% in amino acid sequences, necessitates the development of serotype-specific countermeasures.

    Doris M. Snow, Kathryn Riling, Angie Kimbler, Yero Espinoza, David Wong, Khanh Pham, Zachary Martinez, Carl N. Kraus, Fraser Conrad, Consuelo Garcia-Rodriguez, Ronald R. Cobb, James D. Marks, Milan T. Tomic
  • Safety, Tolerability, and Pharmacokinetics of Oral Nafithromycin (WCK 4873) after Single or Multiple Doses and Effects of Food on Single-Dose Bioavailability in Healthy Adult Subjects
    Pharmacology
    Safety, Tolerability, and Pharmacokinetics of Oral Nafithromycin (WCK 4873) after Single or Multiple Doses and Effects of Food on Single-Dose Bioavailability in Healthy Adult Subjects

    Nafithromycin (WCK 4873), a novel lactone-ketolide, was administered to healthy adult subjects in 2 randomized, double-blind, placebo-controlled, phase 1 studies. In the first-in-human study, single ascending oral doses of nafithromycin (100 to 1,200 mg) were administered to subjects under fasted or fed conditions, with effects of food on bioavailability of nafithromycin studied at the dose levels of 400 and 800 mg.

    Piotr Iwanowski, Ashima Bhatia, Mugdha Gupta, Anasuya Patel, Rajesh Chavan, Ravindra Yeole, David Friedland
  • Modeling and Simulation of Pretomanid Pharmacodynamics in Pulmonary Tuberculosis Patients
    Pharmacology
    Modeling and Simulation of Pretomanid Pharmacodynamics in Pulmonary Tuberculosis Patients

    Pretomanid (PA-824) is a nitroimidazole in clinical testing for the treatment of tuberculosis. A population pharmacodynamic model for pretomanid was developed using a Bayesian analysis of efficacy data from two early bactericidal activity (EBA) studies, PA-824-CL-007 and PA-824-CL-010, conducted in Cape Town, South Africa.

    Michael A. Lyons
  • Population Pharmacokinetics of Doxycycline in Children
    Pharmacology
    Population Pharmacokinetics of Doxycycline in Children

    Doxycycline is a tetracycline-class antimicrobial labeled by the U.S. Food and Drug Administration for children >8 years of age for many common childhood infections. Doxycycline is not labeled for children ≤8 years of age, due to the association between tetracycline-class antibiotics and tooth staining, although doxycycline may be used off-label under severe conditions.

    Elizabeth J. Thompson, Huali Wu, Chiara Melloni, Stephen Balevic, Janice E. Sullivan, Matthew Laughon, Kira M. Clark, Rohit Kalra, Susan Mendley, Elizabeth H. Payne, Jinson Erinjeri, Casey E. Gelber, Barrie Harper, Michael Cohen-Wolkowiez, Christoph P. Hornik
  • Pharmacokinetics and Dialytic Clearance of Isavuconazole during <em>In Vitro</em> and <em>In Vivo</em> Continuous Renal Replacement Therapy
    Clinical Therapeutics
    Pharmacokinetics and Dialytic Clearance of Isavuconazole during In Vitro and In Vivo Continuous Renal Replacement Therapy

    The pharmacokinetics (PK) and dialytic clearance of isavuconazole in vitro and in 7 solid-organ transplant patients undergoing continuous renal replacement therapy (CRRT) were evaluated.

    M. Biagi, D. Butler, X. Tan, S. Qasmieh, K. Tejani, S. Patel, R. M. Rivosecchi, M. H. Nguyen, C. J. Clancy, R. K. Shields, E. Wenzler
  • Observational, Prospective Single-Center Study of Antibiotic Prophylaxis with High-Dose Cefoxitin in Bariatric Surgery
    Pharmacology
    Observational, Prospective Single-Center Study of Antibiotic Prophylaxis with High-Dose Cefoxitin in Bariatric Surgery

    The optimal dose of cefoxitin for antibiotic prophylaxis in obese patients remains uncertain. We evaluated the adequacy of a 4-g dosing regimen of cefoxitin against the most common pathogens that infect patients undergoing bariatric surgery. This observational prospective study included obese patients who required bariatric surgery and a 4-g dose of cefoxitin as an antibiotic prophylaxis. Serum concentrations were measured during...

    Thibaut Belveyre, Philippe Guerci, Elise Pape, Nathalie Thilly, Kossar Hosseini, Laurent Brunaud, Nicolas Gambier, Claude Meistelman, Marie-Reine Losser, Julien Birckener, Julien Scala-Bertola, Emmanuel Novy
  • Open Access
    Doravirine Exposure and HIV-1 Suppression after Switching from an Efavirenz-Based Regimen to Doravirine-Lamivudine-Tenofovir Disoproxil Fumarate
    Antiviral Agents
    Doravirine Exposure and HIV-1 Suppression after Switching from an Efavirenz-Based Regimen to Doravirine-Lamivudine-Tenofovir Disoproxil Fumarate

    Doravirine is a nonnucleoside reverse transcriptase inhibitor that has been approved for the treatment of HIV-1. In a phase 1 trial, doravirine exposure was transiently decreased when treatment was started immediately after the cessation of efavirenz treatment.

    Wayne Greaves, Hong Wan, Ka Lai Yee, Bhargava Kandala, Pavan Vaddady, Carey Hwang
  • First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults
    Clinical Therapeutics
    First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults

    VL-2397 is an antifungal drug with a novel mechanism of action, rapid fungicidal in vitro activity, and potent in vivo activity against Aspergillus fumigatus, including azole-resistant strains. VL2397-101, a phase 1 first-in-human, randomized, double-blind, placebo-controlled dose-escalation study, was conducted in healthy adults to determine the...

    Mammen P. Mammen, Danielle Armas, Frank H. Hughes, Andrew M. Hopkins, Cindy L. Fisher, Pamela A. Resch, Denis Rusalov, Sean M. Sullivan, Larry R. Smith
  • Population Pharmacokinetics and Safety of Piperacillin-Tazobactam Extended Infusions in Infants and Children
    Pharmacology
    Population Pharmacokinetics and Safety of Piperacillin-Tazobactam Extended Infusions in Infants and Children

    Piperacillin-tazobactam (TZP) is frequently used to treat severe hospital-acquired infections in children. We performed a single-center, pharmacokinetic (PK) trial of TZP in children ranging in age from 2 months to 6 years from various clinical subpopulations.

    Céline Thibault, Jean Lavigne, Catherine Litalien, Nastya Kassir, Yves Théorêt, Julie Autmizguine
  • Amikacin Initial Dose in Critically Ill Patients: a Nonparametric Approach To Optimize <em>A Priori</em> Pharmacokinetic/Pharmacodynamic Target Attainments in Individual Patients
    Pharmacology
    Amikacin Initial Dose in Critically Ill Patients: a Nonparametric Approach To Optimize A Priori Pharmacokinetic/Pharmacodynamic Target Attainments in Individual Patients

    Amikacin is commonly used for probabilistic antimicrobial therapy in critically ill patients with sepsis. Its narrow therapeutic margin makes it challenging to determine the right individual dose that ensures the highest efficacy target attainment rate (TAR) in this setting. This study aims to develop a new initial dosing approach for amikacin by optimizing the a priori TAR in this population.

    Clément Boidin, Laurent Bourguignon, Sabine Cohen, Claire Roger, Jean-Yves Lefrant, Jason A. Roberts, Bernard Allaouchiche, Alain Lepape, Arnaud Friggeri, Sylvain Goutelle

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