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sex differences, pharmacokinetics

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https://www.readbyqxmd.com/read/28872908/pharmacokinetic-profile-of-edaravone-a-comparison-between-japanese-and-caucasian-populations
#1
Yoshinobu Nakamaru, Shuji Kinoshita, Atsuhiro Kawaguchi, Koji Takei, Joseph Palumbo, Masayuki Suzuki
BACKGROUND: Amyotrophic lateral sclerosis (ALS) affects persons of all races, and there continues to be a need for effective therapies to treat the disease. OBJECTIVE: To compare the pharmacokinetics (PK) of edaravone between Japanese and Caucasian populations. METHODS: Data from five PK studies among Japanese and Caucasian healthy volunteers were pooled and evaluated. In population PK (PPK) modelling, compartment models and other models with linear elimination were evaluated for appropriateness...
October 2017: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
https://www.readbyqxmd.com/read/28844011/the-pharmacokinetics-of-racemic-mdpv-and-its-r-and-s-enantiomers-in-female-and-male-rats
#2
Michael D Hambuchen, Howard P Hendrickson, Melinda G Gunnell, Samantha J McClenahan, Laura E Ewing, Dillon M Gibson, Michael D Berquist, S Michael Owens
BACKGROUND: These studies investigated the serum pharmacokinetic (PK) profile of racemic (3,4)-methylenedioxypyrovalerone [(R,S)-MDPV)] and its (R)- and (S)-enantiomers in female and male Sprague Dawley rats. METHODS: Intravenous (R,S)-MDPV (3 and 5.6mg/kg) and single enantiomer of (R)- and (S)-MDPV (1.5mg/kg) were administered to both sexes for PK studies. Intraperitoneal (ip) bioavailability was determined at 3mg/kg (R,S)-MDPV. Locomotor activity studies were conducted after ip treatment with saline and 0...
October 1, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28838299/peculiarities-of-feline-hyperadrenocorticism-update-on-diagnosis-and-treatment
#3
Lara A Boland, Vanessa R Barrs
Practical relevance: Hyperadrenocorticism (HAC) is a relatively uncommon endocrinopathy of older cats, with a mean age at diagnosis of 10 years. In addition to pituitary-dependent and adrenal-dependent hypercortisolism, clinical signs of HAC can result from adrenal sex steroid-producing tumours. Clinical challenges: While HAC in cats has many similarities to canine HAC, there are key differences in presentation, diagnosis and response to therapy. Most, but not all, cats with HAC have concurrent diabetes mellitus, which is often insulin resistant...
September 2017: Journal of Feline Medicine and Surgery
https://www.readbyqxmd.com/read/28815798/infant-spinal-anesthesia-do-girls-need-a-larger-dose-of-local-anesthetic
#4
Geoff Frawley, Md Hamidul Huque
BACKGROUND: Gender differences in absorption, distribution, and metabolism of a number of anesthetic agents have been identified in adults. Clinically, adult studies suggest women demonstrate slower onset of opioid analgesic effects, lower spinal and epidural dose requirements, and greater sensitivity to neuromuscular blocking agents. Sex-related differences in the pharmacokinetics and pharmacodynamics of local anesthetics in neonates and infants, however, have not been well documented...
August 17, 2017: Paediatric Anaesthesia
https://www.readbyqxmd.com/read/28719359/levodopa-in-parkinson-s-disease-a-review-of-population-pharmacokinetics-pharmacodynamics-analysis
#5
Amélie Marsot, Romain Guilhaumou, Jean Philippe Azulay, Olivier Blin
BACKGROUND: Parkinson's disease is the second most common neurodegenerative disorder after Alzheimer's disease. Although levodopa remains the single effective agent in the management of Parkinson's disease, the accurate determination of this optimal dosage is complicated by marked between-subject and between-occasion variability in this population.  This review presents a synthesis of the population pharmacokinetic and pharmacodynamic models of levodopa described in Parkinson's disease...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28644086/single-dose-pharmacokinetics-of-piperacillin-tazobactam-in-hispaniolan-amazon-parrots-amazona-ventralis
#6
James W Carpenter, Thomas N Tully, Ronette Gehring, David Sanchez-Migallon Guzman
To determine the pharmacokinetics of piperacillin/tazobactam in Hispaniolan Amazon parrots ( Amazona ventralis ), 8 healthy adult parrots of both sexes were used in a 2-part study. In a pilot study, piperacillin (87 mg/kg) in combination with tazobactam (11 mg/kg) was administered intramuscularly (IM) to 2 birds, and blood samples were obtained at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours after administration. Based on the results obtained, a main study was done in which piperacillin/tazobactam was administered at 2 different doses...
June 2017: Journal of Avian Medicine and Surgery
https://www.readbyqxmd.com/read/28561693/age-and-sex-in-non-hodgkin-lymphoma-therapy-it-s-not-all-created-equal-or-is-it
#7
Michael Pfreundschuh
Age is the most prominent factor for survival in all patients diagnosed with lymphoma, and male sex implies an increased and independent risk for a worse progression-free survival (PFS) and overall survival (OS) in most lymphomas, possibly with the exception of mantle cell lymphoma (MCL). The worse outcome for elderly patients is only partially explained by decreased tolerance to treatment regimens associated with the increasing number and severity of comorbidities. Little is known about specific differences in lymphoma biology with respect to age and sex, and this is changing only slowly despite the recent rise in interest about these issues...
2017: American Society of Clinical Oncology Educational Book
https://www.readbyqxmd.com/read/28546090/safety-and-tolerability-of-long-acting-cabotegravir-injections-in-hiv-uninfected-men-eclair-a-multicentre-double-blind-randomised-placebo-controlled-phase-2a-trial
#8
Martin Markowitz, Ian Frank, Robert M Grant, Kenneth H Mayer, Richard Elion, Deborah Goldstein, Chester Fisher, Magdalena E Sobieszczyk, Joel E Gallant, Hong Van Tieu, Winkler Weinberg, David A Margolis, Krischan J Hudson, Britt S Stancil, Susan L Ford, Parul Patel, Elizabeth Gould, Alex R Rinehart, Kimberly Y Smith, William R Spreen
BACKGROUND: Cabotegravir (GSK1265744) is an HIV-1 integrase strand transfer inhibitor with potent antiviral activity and a long half-life when administered by injection that prevented simian-HIV infection upon repeat intrarectal challenge in male macaques. We aimed to assess the safety, tolerability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk of HIV-1 infection. METHODS: We did this multicentre, double-blind, randomised, placebo-controlled, phase 2a trial at ten sites in the USA...
August 2017: Lancet HIV
https://www.readbyqxmd.com/read/28540640/a-population-pharmacokinetic-and-pharmacodynamic-analysis-of-abemaciclib-in-a-phase-i-clinical-trial-in-cancer-patients
#9
Sonya C Tate, Amanda K Sykes, Palaniappan Kulanthaivel, Edward M Chan, P Kellie Turner, Damien M Cronier
BACKGROUND AND OBJECTIVES: Abemaciclib, a dual inhibitor of cyclin-dependent kinases 4 and 6, has demonstrated clinical activity in a number of different cancer types. The objectives of this study were to characterize the pharmacokinetics of abemaciclib in cancer patients using population pharmacokinetic (popPK) modeling, and to evaluate target engagement at clinically relevant dose levels. METHODS: A phase I study was conducted in cancer patients which incorporated intensive pharmacokinetic sampling after single and multiple oral doses of abemaciclib...
May 24, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28523515/distribution-of-exogenous-and-endogenous-cyp3a-markers-and-related-factors-in-healthy-males-and-females
#10
Jieon Lee, Andrew HyoungJin Kim, SoJeong Yi, SeungHwan Lee, Seo Hyun Yoon, Kyung-Sang Yu, In-Jin Jang, Joo-Youn Cho
Cytochrome P450 (CYP) 3A is an important drug-metabolizing enzyme in humans. Assessing CYP3A activity is necessary for predicting therapeutic outcomes or the potential adverse events of various therapeutics. This study sought to evaluate the distribution of endogenous and exogenous markers reflecting hepatic CYP3A activity and related factors affecting its activity in healthy male and female. Each subject was given a single 1 mg dose of midazolam intravenously. Pharmacokinetics, pharmacometabolomics, and pharmacogenomics analyses were performed to evaluate CYP3A activity...
July 2017: AAPS Journal
https://www.readbyqxmd.com/read/28449232/safety-pharmacokinetics-and-pharmacological-effects-of-the-selective-androgen-receptor-modulator-gsk2881078-in-healthy-men-and-postmenopausal-women
#11
Richard V Clark, Ann C Walker, Susan Andrews, Philip Turnbull, Jeffrey A Wald, Mindy H Magee
AIM: Selective androgen receptor modulators (SARMs) induce anabolic effects on muscle without the adverse effects of androgenic steroids. In this first-in-human study, we report the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of the SARM GSK2881078. METHODS: In Part A, healthy young men (n = 10) received a single dose of study drug (0 mg, 0.05 mg, 0.1 mg, 0.2 mg GSK2881078 or matching-placebo). In Part B, repeat-dose cohorts in men (n = 65) were 0...
October 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28440204/apixaban-metabolism-pharmacologic-properties-and-drug-interaction
#12
Peter Kubisz, Lucia Stanciakova, Miroslava Dobrotova, Matej Samos, Marian Mokan, Jan Stasko
BACKGROUND: Apixaban is an oral, potent, highly selective, reversible and direct inhibitor of activated coagulation factor X, that is the end point of the intrinsic and extrinsic coagulation pathway. Additionally, apixaban has the capacity to indirectly inhibit thrombin-induced platelet aggregation. This new oral anticoagulant represents an immediate-release form of peroral drug with quick dissolution, linear pharmacokinetics, good bioavailability and rapid onset and offset of action...
April 24, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28419480/characterization-of-neutropenia-in-advanced-cancer-patients-following-palbociclib-treatment-using-a-population-pharmacokinetic-pharmacodynamic-modeling-and-simulation-approach
#13
Wan Sun, Peter J O'Dwyer, Richard S Finn, Ana Ruiz-Garcia, Geoffrey I Shapiro, Gary K Schwartz, Angela DeMichele, Diane Wang
Neutropenia is the most commonly reported hematologic toxicity following treatment with palbociclib, a cyclin-dependent kinase 4/6 inhibitor approved for metastatic breast cancer. Using data from 185 advanced cancer patients receiving palbociclib in 3 clinical trials, a pharmacokinetic-pharmacodynamic model was developed to describe the time course of absolute neutrophil count (ANC) and quantify the exposure-response relationship for neutropenia. These analyses help in understanding neutropenia associated with palbociclib and its comparison with chemotherapy-induced neutropenia...
September 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28416614/modeling-combined-immunosuppressive-and-anti-inflammatory-effects-of-dexamethasone-and-naproxen-in-rats-predicts-the-steroid-sparing-potential-of-naproxen
#14
Xiaonan Li, Debra C DuBois, Dawei Song, Richard R Almon, William J Jusko, Xijing Chen
Dexamethasone (DEX), a widely prescribed corticosteroid, has long been the cornerstone of the treatment of inflammation and immunologic dysfunctions in rheumatoid arthritis. Corticosteroids are frequently used in combination with other antirheumatic agents such as nonsteroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs to mitigate disease symptoms and minimize unwanted effects. We explored the steroid dose-sparing potential of the NSAID naproxen (NPX) with in vitro and in vivo studies...
July 2017: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/28412445/methylphenidate-effects-in-the-young-brain-friend-or-foe
#15
REVIEW
Sara Loureiro-Vieira, Vera Marisa Costa, Maria de Lourdes Bastos, Félix Carvalho, João Paulo Capela
Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neuropsychiatry disorders in children and adolescents, and methylphenidate (MPH) is a first-line stimulant drug available worldwide for its treatment. Despite the proven therapeutic efficacy, concerns have been raised regarding the possible consequences of chronic MPH exposure during childhood and adolescence. Disturbances in the neurodevelopment at these crucial stages are major concerns given the unknown future life consequences...
August 2017: International Journal of Developmental Neuroscience
https://www.readbyqxmd.com/read/28400722/sex-differences-in-the-physiological-and-behavioral-effects-of-chronic-oral-methylphenidate-treatment-in-rats
#16
Lisa S Robison, Michalis Michaelos, Jason Gandhi, Dennis Fricke, Erick Miao, Chiu-Yim Lam, Anthony Mauceri, Melissa Vitale, Junho Lee, Soyeh Paeng, David E Komatsu, Michael Hadjiargyrou, Panayotis K Thanos
Methylphenidate (MP) is a psychostimulant prescribed for Attention Deficit Hyperactivity Disorder. Previously, we developed a dual bottle 8-h-limited-access-drinking-paradigm for oral MP treatment of rats that mimics the pharmacokinetic profile of treated patients. This study assessed sex differences in response to this treatment. Male and female Sprague Dawley rats were assigned to one of three treatment groups at 4 weeks of age (n = 12/group): Control (water), low dose (LD) MP, and high dose (HD) MP. Rats drank 4 mg/kg MP (LD) or 30 mg/kg MP (HD) during the first hour, and 10 mg/kg (LD) or 60 mg/kg MP (HD) for the remaining 7 h each day...
2017: Frontiers in Behavioral Neuroscience
https://www.readbyqxmd.com/read/28364695/the-influence-of-a-single-and-chronic-administration-of-venlafaxine-on-tramadol-pharmacokinetics-in-a-rabbit-model
#17
Danuta Szkutnik-Fiedler, Tomasz Grabowski, Monika Balcerkiewicz, Michał Michalak, Irina Pilipczuk, Łukasz Wyrowski, Hanna Urjasz, Edmund Grześkowiak
BACKGROUND: The combined use of tramadol with selective serotonin and norepinephrine reuptake inhibitors e.g. venlafaxine may be associated with serotonin syndrome. No previous studies exist examining the influence of a weak CYP2D6 inhibitor venlafaxine on the pharmacokinetics of tramadol. Therefore, the aim of this study was to determine the effect of a single and chronic administration of venlafaxine on the pharmacokinetics of tramadol using a rabbit model. METHODS: Adult New Zealand white rabbits of both sexes (n=21) were used...
June 2017: Pharmacological Reports: PR
https://www.readbyqxmd.com/read/28349386/pharmacokinetics-and-tolerability-of-a-single-dose-of-semaglutide-a-human-glucagon-like-peptide-1-analog-in-subjects-with-and-without-renal-impairment
#18
Thomas C Marbury, Anne Flint, Jacob B Jacobsen, Julie Derving Karsbøl, Kenneth Lasseter
BACKGROUND: The pharmacokinetics and tolerability of semaglutide, a once-weekly human glucagon-like peptide-1 analog in development for the treatment of type 2 diabetes mellitus, were investigated in subjects with/without renal impairment (RI). METHODS: Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg. Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity...
March 27, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28329228/gender-differences-in-the-effects-of-cardiovascular-drugs
#19
J Tamargo, G Rosano, T Walther, J Duarte, A Niessner, J C Kaski, C Ceconi, H Drexel, K Kjeldsen, G Savarese, C Torp-Pedersen, D Atar, B S Lewis, S Agewall
Although sex-specific differences in cardiovascular medicine are well known, the exact influences of sex on the effect of cardiovascular drugs remain unclear. Women and men differ in body composition and physiology (hormonal influences during the menstrual cycle, menopause, and pregnancy) and they present differences in drug pharmacokinetics (absorption, distribution, metabolism, and excretion) and pharmacodynamics, so that is not rare that they may respond differently to cardiovascular drugs. Furthermore, women are also less often treated with evidence-based drugs thereby preventing optimization of therapeutics for women of all ages, experience more relevant adverse drug reactions than men, and remain underrepresented in most clinical trials...
July 1, 2017: European Heart Journal. Cardiovascular Pharmacotherapy
https://www.readbyqxmd.com/read/28318987/a-clinical-evaluation-of-the-pharmacokinetics-and-pharmacodynamics-of-intravenous-alfaxalone-in-cyclodextrin-in-male-and-female-rats-following-a-loading-dose-and-constant-rate-infusion
#20
Kate L White, Stuart Paine, John Harris
OBJECTIVE: To characterise, as a clinical study, the pharmacokinetics and pharmacodynamics and describe the hypnotic effect of the neurosteroid alfaxalone (3α-hydroxy-5 α-pregnane-11, 20-dione) formulated with 2-hydroxypropyl-β-cyclodextrin in male and female rats. STUDY DESIGN: Prospective, experimental laboratory study. ANIMALS: A total of 12 (six male and six female) adult, aged-matched Sprague Dawley rats. METHODS: Surgery and instrumentation was performed under isoflurane anaesthesia in an oxygen/nitrous oxide mixture (1:2) and local anaesthetic infiltration...
February 1, 2017: Veterinary Anaesthesia and Analgesia
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