journal
https://read.qxmd.com/read/39011960/population-pharmacokinetic-analysis-of-dolutegravir-in-treatment-experienced-adults-living-with-hiv-1
#1
JOURNAL ARTICLE
Hardik Chandasana, Mark Bush, Mounir Ait-Khaled, Brian Wynne, Sherene Min, Rashmi Mehta
The World Health Organization has recommended the use of dolutegravir (DTG) for both first and second-line antiretroviral treatment in both adults and children down to 4 weeks of age. We developed a population pharmacokinetic(PopPK) model following oral administration of DTG 50 mg QD and 50 mg BID in HIV-infected treatment-experienced adults (607) based on pooled data from four phase 2/3 trials. DTG population pharmacokinetics are described by a one-compartment model with first-order absorption, absorption lag-time, and first-order elimination...
July 16, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38988185/safety-pharmacokinetics-and-pharmacodynamics-of-the-new-aldose-reductase-inhibitor-govorestat-at-007-after-a-single-and-multiple-doses-in-participants-in-a-phase-1-2-study
#2
JOURNAL ARTICLE
Riccardo Perfetti, Evan Bailey, Stella Wang, Richard Mills, Ramon Mohanlal, Shoshana Shendelman
In classic galactosemia (CG) patients, aldose reductase (AR) converts galactose to galactitol. In a phase 1/2, placebo-controlled study (NCT04117711), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of govorestat were evaluated after single and multiple ascending doses (0.5-40 mg/kg) in healthy adults (n = 81) and CG patients (n = 14). Levels of govorestat in plasma and cerebrospinal fluid (CSF) and blood levels of galactitol, galactose, and galactose-1-phosphate (Gal-1p) were measured for population PK and PK/PD analyses...
July 10, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38973651/labetalol-dosing-in-pregnancy-pbpk-pd-and-cyp2c19-polymorphisms
#3
JOURNAL ARTICLE
Xiaomei I Liu, Dionna J Green, John van den Anker, Joaquin Calderon, Homa Ahmadzia, Gilbert J Burckart, André Dallmann
As detailed information on the pharmacokinetics (PK) of labetalol in pregnant people are lacking, the aims of this study were: (1) to build a physiologically based PK (PBPK) model of labetalol in non-pregnant individuals that incorporates different CYP2C19 genotypes (specifically, *1/*1, *1/*2 or *3, *2/*2, and *17/*17); (2) to translate this model to the second and third trimester of pregnancy; and (3) to combine the model with a previously published direct pharmacodynamic (PD) model to predict the blood pressure lowering effect of labetalol in the third trimester...
July 8, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38973383/exposure-response-modeling-in-adults-and-adolescents-with-schizophrenia-to-support-the-extrapolation-of-brexpiprazole-efficacy-to-adolescents
#4
JOURNAL ARTICLE
Xiaofeng Wang, Mathangi Gopalakrishnan, Benjamin Rich, Jogarao V Gobburu, Frank Larsen, Arash Raoufinia
In order to accelerate drug development and avoid unnecessary drug trials in vulnerable pediatric populations, the US Food and Drug Administration (FDA) released a general advice letter to sponsors permitting the effectiveness of atypical antipsychotics for the treatment of schizophrenia in adults to be extrapolated to adolescents. Extrapolation is based on the evidence-based assumptions that (1) disease characteristics and (2) response to therapy, are similar in adults and adolescents. Whereas the FDA validated the extrapolation approach using data from multiple drug development programs, aripiprazole data are the most relevant to confirm the validity of the extrapolation approach for brexpiprazole, since aripiprazole and brexpiprazole both modulate dopaminergic and serotonergic signaling in the brain...
July 8, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38967110/comparison-of-anti-hepatitis-a-antibody-pharmacokinetics-in-healthy-australian-subjects-receiving-standard-or-weight-based-dosing-of-polyvalent-immunoglobulin
#5
JOURNAL ARTICLE
Megan K Young, Shu-Kay Ng, Helen M Faddy, Graeme R Nimmo
This randomized controlled trial compared two dosing regimens of the polyvalent immunoglobulin available for hepatitis A post-exposure prophylaxis in Australia. Participants were randomized to receive either 270 IU (standard dose) or 3.375 IU/kg (dose by weight). Quantitative serial serum hepatitis A antibody concentrations were measured at baseline and then on days 1, 3, 7, 28, and 50. Fifteen participants completed the trial. Serum hepatitis A antibody concentrations were not different between the study groups at any time point...
July 5, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38956868/accp-position-statement-on-unregulated-psychotropic-products
#6
JOURNAL ARTICLE
Tao Long, Sindura Gollamudi, Sudhakar Pai
No abstract text is available yet for this article.
July 2, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38953605/pharmacokinetics-of-human-plasma-derived-antithrombin-in-pediatric-patients-supported-on-extracorporeal-membrane-oxygenation
#7
JOURNAL ARTICLE
Dawoon Jung, David Procaccini, Jennifer Roem, Ankur Patel, Derek K Ng, Melania M Bembea, Jogarao V S Gobburu
Extracorporeal membrane oxygenation (ECMO) support of critically ill pediatric patients is associated with increased risk of thromboembolic events, and unfractionated heparin is used commonly for anticoagulation. Given reports of acquired antithrombin (AT) deficiency in this patient population and associated concern for heparin resistance, AT activity measurement and off-label AT replacement have become common in pediatric ECMO centers despite limited optimal dosing regimens. We conducted a retrospective cohort study of pediatric ECMO patients (0 to <18 years) at a single academic center to characterize the pharmacokinetics (PK) of human plasma-derived AT...
July 2, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38924121/pharmacotherapy-of-weight-loss-and-obesity-with-a-focus-on-glp-1-receptor-agonists
#8
REVIEW
Merle Myerson, Rodis D Paparodis
Obesity is a disease of epidemic proportions in the United States and contributes to morbidity and mortality for a large part of the population. In addition, the financial costs of this disease to society are high. Lifestyle modifications are key to prevention and treatment but adherence and long-term success have been challenging. Bariatric surgery has been available and pharmacologic approaches, first developed in the 1950s, continue to be an option; however, existing formulations have not provided optimal clinical efficacy and have had many concerning adverse effects...
June 26, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38924604/drug-drug-interaction-between-oral-zamicastat-and-continuous-epoprostenol-infusion-at-steady-state-conditions-in-healthy-subjects
#9
JOURNAL ARTICLE
Marlene Fonseca, Andreia Guimarães, Helena Gama, Luís Magalhães, Sara Carolina Henriques, Nuno Silva, Luis Almeida, Patrício Soares-da-Silva
This study intended to evaluate the interactions between zamicastat and epoprostenol in healthy human subjects. This was a single-center, open-label, two-period study. In period 1, epoprostenol 8 ng/kg/min was administered alone. In period 2, epoprostenol 8 ng/kg/min was administered following an 8-day treatment with zamicastat. Since the initial dose of epoprostenol showed to be insufficiently tolerated, it was decreased to 6 ng/kg/min. Blood samples were collected to determine the metabolites of epoprostenol and concentrations of zamicastat and its metabolites...
June 24, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38923537/cerebrospinal-fluid-pharmacokinetics-of-nicardipine-following-intrathecal-administration-in-subarachnoid-hemorrhage-patients
#10
JOURNAL ARTICLE
Ofer Sadan, Yoo-Seong Jeong, Shany Cohen-Sadan, Eashani Sathialingam, Erin M Buckley, Prem A Kandiah, Jonathan A Grossberg, William Asbury, William J Jusko, Owen B Samuels
Subarachnoid hemorrhage (SAH) is a devastating type of stroke, leading to high mortality and morbidity rates. Cerebral vasospasm and delayed cerebral ischemia (DCI) are common complications following SAH that contribute significantly to the poor outcomes observed in these patients. Intrathecal (IT) nicardipine delivered via an existing external ventricular drain is an off-label intervention that has been shown to be correlated with reduced DCI and improved patient outcomes. The current study aims to characterize the population pharmacokinetic (popPK) properties of intermittent IT nicardipine...
June 24, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38898531/development-and-evaluation-of-ontogeny-functions-of-the-major-udp-glucuronosyltransferase-enzymes-to-underwrite-physiologically-based-pharmacokinetic-modeling-in-pediatric-populations
#11
JOURNAL ARTICLE
Nashid Farhan, Upendra P Dahal, Jan Wahlstrom
Uridine 5'-diphospho-glucuronosyltransferases (UGTs) demonstrate variable expression in the pediatric population. Thus, understanding of age-dependent maturation of UGTs is critical for accurate pediatric pharmacokinetics (PK) prediction of drugs that are susceptible for glucuronidation. Ontogeny functions of major UGTs have been previously developed and reported. However, those ontogeny functions are based on in vitro data (i.e., enzyme abundance, in vitro substrate activity, and so on) and therefore, may not translate to in vivo maturation of UGTs in the clinical setting...
June 19, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38874130/efficacy-and-safety-of-oral-semaglutide-in-the-treatment-of-type-2-diabetes-a-meta-analysis
#12
JOURNAL ARTICLE
Lin Zhang, Zixin Hua, Zhenwei Fang, Juanjuan Wei, Yang Lin
This study aims to systematically review the efficacy and safety of oral semaglutide in the treatment of type 2 diabetes mellitus (T2DM) and provide a basis for the rational use of the drug in clinical practice. From the database's inception until February 2023, a systematic search was conducted in PubMed, Embase, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Database, and China Science and Technology Journal Database to identify randomized controlled trials (RCTs) comparing the efficacy of oral semaglutide at dosages of 3, 7, and 14 mg (trial group) against placebo or other positive control drugs (control group) for the treatment of T2DM...
June 14, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38837775/relative-bioavailability-of-omaveloxolone-when-capsules-are-sprinkled-over-and-mixed-in-applesauce-compared-with-administration-as-intact-omaveloxolone-capsules-a-phase-1-randomized-open-label-single-dose-crossover-study-in-healthy-adults
#13
JOURNAL ARTICLE
Scott M Hynes, Angie Goldsberry, Patrick D Henneghan, Masako Murai, Aparna Shinde, Jason A Wells, Lucy Wu, Tony Wu, Hamim Zahir, Seemi Khan
Omaveloxolone (SKYCLARYS® ) is approved for the treatment of Friedreich ataxia (FA) in patients aged ≥16 years in the United States and European Union (EU). The recommended dosage is 150 mg administered orally once daily as three 50-mg capsules. However, some patients with FA may have oropharyngeal dysphagia or difficulty swallowing whole capsules; therefore, alternate method(s) of administration are needed. A Phase 1 clinical study in 32 healthy volunteers evaluated the relative bioavailability, safety, and tolerability of a single dose of omaveloxolone when capsule contents were sprinkled on and mixed in applesauce compared to when taken as intact capsules...
June 4, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38831739/chatgpt-and-factual-knowledge-questions-regarding-clinical-pharmacy-response-to-letter-to-the-editor
#14
LETTER
Merel van Nuland
No abstract text is available yet for this article.
June 4, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38831738/backpedaling-on-baclofen-highlighting-concerns-surrounding-baclofen-use-in-phenibut-withdrawal-letter-to-the-editor-response
#15
LETTER
Scott R Penzak, Marilyn Bulloch
No abstract text is available yet for this article.
June 4, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38831727/chatgpt-and-factual-knowledge-questions-regarding-clinical-pharmacy-correspondence
#16
LETTER
Hinpetch Daungsupawong, Viroj Wiwanitkit
No abstract text is available yet for this article.
June 4, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38831713/sodium-glucose-cotransporter-2-inhibitor-suppresses-endoplasmic-reticulum-stress-and-oxidative-stress-in-diabetic-nephropathy-through-nrf2-signaling-a-clinical-and-experimental-study
#17
JOURNAL ARTICLE
Murali Krishna Prasad, Paul S Victor, Goutham V Ganesh, Udayama Juttada, Satyavani Kumpatla, Vijay Viswanathan, Kunka Mohanram Ramkumar
Diabetic nephropathy (DN), a severe complication of type 2 diabetes mellitus (T2DM), is marked by heightened endoplasmic reticulum stress (ERS) and oxidative stress (OS) due to protein misfolding and free radical generation. We investigated the sodium-glucose co-transporter-2 inhibitor (SGLT2i), canagliflozin (Cana), in alleviating ERS and OS in DN patients and THP-1 cells under hyperglycemic condition. A total of 120 subjects were divided into four groups, with 30 subjects in each group: healthy controls, T2DM individuals, DN patients receiving standard treatment, and those treated with Cana...
June 4, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38831707/potential-drug-drug-interactions-analysis-in-polish-pediatric-pneumonology-units-including-cystic-fibrosis-patients
#18
JOURNAL ARTICLE
Arkadiusz Adamiszak, Julia Drobińska, Irena Wojsyk-Banaszak, Edmund Grześkowiak, Agnieszka Bienert
The lack of data on drug-drug interactions in pediatrics represents a relevant problem in making appropriate therapeutic decisions. Our study aimed to investigate the incidence and risk factors for potential drug-drug interactions (pDDIs) in pediatric pneumonology units, including cystic fibrosis patients. We performed a 6-month prospective observational study during which clinical pharmacists, using the Lexicomp Drug Interactions checker, screened medical records to identify pDDIs. Spearman's rank coefficient, logistic regression, and the Mann-Whitney U test were used to identify correlations, analyze risk factors for pDDIs, and compare cystic fibrosis patients with the rest, respectively...
June 3, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38813747/novel-patient-friendly-orodispersible-formulation-of-ivermectin-is-associated-with-enhanced-palatability-controlled-absorption-and-less-variability-high-potential-for-pediatric-use
#19
JOURNAL ARTICLE
Kim Dao, Michael Buettcher, Klervi Golhen, Jonas Kost, Andreas Schittny, Urs Duthaler, Andrew Atkinson, David Haefliger, Monia Guidi, Carine Bardinet, Haithem Chtioui, Abdelwahab Boulekbache, Thierry Buclin, Jörg Huwyler, Marc Pfister, Laura E Rothuizen
Ivermectin has been used since the 1980s as an anthelmintic and antiectoparasite agent worldwide. Currently, the only available oral formulation is tablets designed for adult patients. A patient-friendly orodispersible tablet formulation designed for pediatric use (CHILD-IVITAB) has been developed and is entering early phase clinical trials. To inform the pediatric program of CHILD-IVITAB, 16 healthy adults were enrolled in a phase I, single-center, open-label, randomized, 2-period, crossover, single-dose trial which aimed to compare palatability, tolerability, and bioavailability and pharmacokinetics of CHILD-IVITAB and their variability against the marketed ivermectin tablets (STROMECTOL) at a single dose of 12 mg in a fasting state...
May 30, 2024: Journal of Clinical Pharmacology
https://read.qxmd.com/read/38804820/exposure-to-macrolides-during-pregnancy-and-the-risk-for-spontaneous-abortions-a-population-based-retrospective-cohort-study
#20
JOURNAL ARTICLE
Shani Hegger, Amalia Levy, Gideon Koren, Eitan Lunenfeld, Sharon Daniel
Previous studies evaluating the risk of spontaneous abortions following exposure to macrolides reported controversial results. The goal of the current study was to examine the risk for spontaneous abortions following exposure to macrolides during pregnancy. We conducted a population-based retrospective cohort study by linking three computerized databases: Clalit Health Services drug dispensation database, Soroka Medical Center (SMC) birth database, and SMC hospitalizations database. Multivariate time-varying Cox regressions were performed and adjusted for suspected confounders and known risk factors for spontaneous abortions...
May 28, 2024: Journal of Clinical Pharmacology
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