Gonçalves, Paulo Vinicius Bernardes Moreira, Fernanda de Lima Benzi, Jhohann Richard de Lima Duarte, Geraldo Lanchote, Vera Lucia
Published in
Journal of clinical pharmacology
The third trimester of pregnancy is related to physiological changes that can modify the process of absorption, distribution, metabolism, and excretion and, consequently, the efficacy and toxicity of drugs. However, little is known about furosemide pharmacokinetics and placental transfer in pregnancy. This study evaluated the maternal-fetal pharmac...
Tse, Susanna Dowty, Martin E Menon, Sujatha Gupta, Pankaj Krishnaswami, Sriram
Published in
Journal of clinical pharmacology
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It is eliminated via multiple pathways including oxidative metabolism (∼70%) and renal excretion (29%). This study aimed to predict the impact of drug-drug interactions and renal or hepatic impairment on tofacitinib ...
Ng, Tat Ming Heng, Shi Thong Oon, Jolene Chan, Monica Tam, Vincent H
Published in
Journal of clinical pharmacology
Vancomycin is an antibiotic commonly used to treat serious Gram-positive infections. Patients requiring prolonged therapy in Singapore routinely receive intermittent vancomycin infusion in the hospital and are switched to continuous infusion for outpatient parenteral antibiotic therapy. During this transition of care, there may be a risk of not ach...
Tegenge, Million A Mahmood, Iftekhar
Published in
Journal of clinical pharmacology
Dosing of coagulation factor products is mainly determined based on a patient's body weight; however, several studies have reported high interindividual variability in their pharmacokinetics (PK). The objective of this study was to develop and evaluate 2 sparse sampling methods for the estimation of AUC of recombinant factor IX (BeneFIX) as proof o...
Ber, Justyna Wiczling, Paweł Hołysz, Marcin Klupczyńska, Agnieszka Bartkowska-Śniatkowska, Alicja Bieda, Krzysztof Smuszkiewicz, Piotr Nowicka, Małgorzata Żurański, Łukasz Sobczyński, Paweł
...
Published in
Journal of clinical pharmacology
Dexmedetomidine is a hepatically eliminated drug with sedative, anxiolytic, sympatholytic, and analgesic properties that has been increasingly used for various indications in the form of a short or continuous intravenous infusion. This study aimed to propose a population pharmacokinetic (PK) model of dexmedetomidine in a heterogeneous group of inte...
Deng, Rong She, Gaohong Maia, Mauricio Lim, Jeremy J Peck, Melicent C McBride, Jacqueline M Kulkarni, Priya Horn, Priscilla Castro, Aide Newton, Elizabeth
...
Published in
Journal of clinical pharmacology
MHAA4549A is a human anti-influenza A monoclonal antibody developed to treat influenza A. We report MHAA4549A serum, nasopharyngeal, and tracheal aspirate pharmacokinetics from a phase 2b study in hospitalized patients with severe influenza A. Patients were randomized 1:1:1 into 3 groups receiving single intravenous doses of 3600 mg (n = 55) or 840...
An, Guohua Lee, Kin Sing Stephen Yang, Jun Hammock, Bruce D
Published in
Journal of clinical pharmacology
Pharmacological target-mediated drug disposition (TMDD) represents a special source of nonlinear pharmacokinetics, and its occurrence in large-molecule compounds has been well recognized because numerous protein drugs have been reported to have TMDD due to specific binding to their pharmacological targets. Although TMDD can also happen in small-mol...
VanLandingham, Kevan E Crockett, Julie Taylor, Lesley Morrison, Gilmour
Published in
Journal of clinical pharmacology
We investigated the effects of cannabidiol (CBD; 21-day maintenance dose) on the pharmacokinetics (PK) of clobazam (CLB) and monitored the safety of CBD (or placebo) plus CLB in 20 patients with uncontrolled epilepsy on stable doses of CLB. Blood samples collected until 24 hours postdose were evaluated by liquid chromatography tandem mass spectrome...
Rohr, Brit Silja Mikus, Gerd
Published in
Journal of clinical pharmacology
Numerous drug-drug interaction (DDI) trials have to be conducted in healthy volunteers based on current regulatory guidelines. Because the worst-case scenario of strong cytochrome P450 (CYP) inhibitors has to be tested, the results and their validity have to be balanced with the risk to volunteer safety. The use of ketoconazole in clinical DDI stud...
Yu, Yanke Elmeliegy, Mohamed Litton, Jennifer K Tudor, Iulia Cristina Czibere, Akos Zheng, Jenny Wang, Diane D
Published in
Journal of clinical pharmacology
In the phase 3 EMBRACA trial, treatment with the poly(ADP-ribose) polymerase inhibitor, talazoparib, led to significantly improved progression-free survival (PFS) compared with chemotherapy (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P 12 months were independent covariates associated with longer PFS. The association of talazoparib expo...
