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Clinical Pharmacokinetics

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https://www.readbyqxmd.com/read/29777529/pharmacokinetics-of-ads-5102-amantadine-extended-release-capsules-administered-once-daily-at-bedtime-for-the-treatment-of-dyskinesia
#1
Robert A Hauser, Rajesh Pahwa, William A Wargin, Cindy J Souza-Prien, Natalie McClure, Reed Johnson, Jack T Nguyen, Rajiv Patni, Gregory T Went
BACKGROUND: Preclinical and clinical studies suggest amantadine immediate-release (IR) may reduce dyskinesia in Parkinson's disease (PD), although higher doses are associated with increased CNS adverse events (AEs). ADS-5102 is an extended release amantadine capsule formulation, designed for once-daily dosing at bedtime (qhs) to provide high concentrations upon waking and throughout the day, with lower concentrations in the evening. The pharmacokinetics (PK) of ADS-5102 were assessed in two phase I studies in healthy subjects, and a blinded, randomized phase II/III dose-finding study in PD patients...
May 18, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29777528/state-of-the-art-review-on-physiologically-based-pharmacokinetic-modeling-in-pediatric-drug-development
#2
REVIEW
Venkata Yellepeddi, Joseph Rower, Xiaoxi Liu, Shaun Kumar, Jahidur Rashid, Catherine M T Sherwin
Physiologically based pharmacokinetic modeling and simulation is an important tool for predicting the pharmacokinetics, pharmacodynamics, and safety of drugs in pediatrics. Physiologically based pharmacokinetic modeling is applied in pediatric drug development for first-time-in-pediatric dose selection, simulation-based trial design, correlation with target organ toxicities, risk assessment by investigating possible drug-drug interactions, real-time assessment of pharmacokinetic-safety relationships, and assessment of non-systemic biodistribution targets...
May 18, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29752633/clinical-pharmacokinetic-and-pharmacodynamic-considerations-in-the-treatment-of-ulcerative-colitis
#3
REVIEW
Sophie E Berends, Anne S Strik, Mark Löwenberg, Geert R D'Haens, Ron A A Mathôt
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) of unknown etiology, probably caused by a combination of genetic and environmental factors. The treatment of patients with active UC depends on the severity, localization and history of IBD medication. According to the classic step-up approach, treatment with 5-aminosalicylic acid compounds is the first step in the treatment of mild to moderately active UC. Corticosteroids, such as prednisolone are used in UC patients with moderate to severe disease activity, but only for remission induction therapy because of side effects associated with long-term use...
May 12, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29737457/a-physiologically-based-pharmacokinetic-model-to-describe-ciprofloxacin-pharmacokinetics-over-the-entire-span-of-life
#4
Jan-Frederik Schlender, Donato Teutonico, Katrin Coboeken, Katrin Schnizler, Thomas Eissing, Stefan Willmann, Ulrich Jaehde, Heino Stass
BACKGROUND: Physiologically-based pharmacokinetic (PBPK) modeling has received growing interest as a useful tool for the assessment of drug pharmacokinetics by continuous knowledge integration. OBJECTIVE: The objective of this study was to build a ciprofloxacin PBPK model for intravenous and oral dosing based on a comprehensive literature review, and evaluate the predictive performance towards pediatric and geriatric patients. METHODS: The aim of this report was to establish confidence in simulations of the ciprofloxacin PBPK model along the development process to facilitate reliable predictions outside of the tested adult age range towards the extremes of ages...
May 8, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29736841/evaluation-of-the-interaction-of-amino-acid-infusion-on-177-lu-dotatate-pharmacokinetics-in-patients-with-gastroenteropancreatic-neuroendocrine-tumors
#5
Alicja Puszkiel, Mathilde Bauriaud-Mallet, Roxane Bourgeois, Lawrence Dierickx, Frédéric Courbon, Etienne Chatelut
BACKGROUND AND OBJECTIVE: 177 Lu-Dotatate is a radio-labeled analog of somatostatin used in the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. In order to prevent nephrotoxic effects of 177 Lu-Dotatate a co-infusion of amino acids (AA) is administered, resulting in a decrease in tubular renal reabsorption of 177 Lu-Dotatate. This study aimed to quantify the impact of AA co-infusion on the pharmacokinetics of 177 Lu-Dotatate in cancer patients and to evaluate its relationship with toxicity during the first treatment cycle (C1)...
May 8, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29736840/author-s-reply-to-reith-morbidly-obese-patients-exhibit-increased-cyp2e1-mediated-oxidation-of-acetaminophen
#6
LETTER
Anne van Rongen, Pyry A J Välitalo, Catherijne A J Knibbe
No abstract text is available yet for this article.
May 8, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29730761/clinical-pharmacokinetics-and-pharmacodynamics-of-dalcetrapib
#7
REVIEW
Donald M Black, Darren Bentley, Sunny Chapel, Jongtae Lee, Emily Briggs, Therese Heinonen
The cholesterol ester transfer protein (CETP) inhibitor dalcetrapib has been under evaluation for its potential to prevent cardiovascular (CV) events for almost two decades. The current clinical development program, representing new advances in precision medicine and focused on a genetically defined population with acute coronary syndrome (ACS), is supported by a large body of pharmacokinetic and pharmacodynamic data as well as substantial clinical experience in over 13,000 patients and volunteers. Dalcetrapib treatment of 600 mg/day produces significant inhibition of CETP activity, and has been utilized in phase II and III studies, including CV endpoint trials...
May 5, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29725999/clinical-pharmacokinetics-and-pharmacodynamics-of-isavuconazole
#8
REVIEW
Matthew W McCarthy, Brad Moriyama, Ruta Petraitiene, Thomas J Walsh, Vidmantas Petraitis
In March 2015, the extended-spectrum triazole antifungal isavuconazole was granted approval by the US Food and Drug Administration and the European Medicines Agency for the treatment of invasive aspergillosis and mucormycosis. Isavuconaozle has activity against a broad range of yeasts, dimorphic fungi, and molds and is associated with fewer toxicities than voriconazole. It also has predictable pharmacokinetics in adults, fewer drug-drug interactions than many existing antifungal agents, and is available in both oral and β-cyclodextrin-free intravenous formulations...
May 4, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29725998/comment-on-morbidly-obese-patients-exhibit-increased-cyp2e1-mediated-oxidation-of-acetaminophen
#9
LETTER
David M Reith
No abstract text is available yet for this article.
May 3, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29725997/population-pharmacokinetic-pharmacodynamic-analysis-of-alirocumab-in-healthy-volunteers-or-hypercholesterolemic-subjects-using-an-indirect-response-model-to-predict-low-density-lipoprotein-cholesterol-lowering-support-for-a-biologics-license-application-submission
#10
Xavier Nicolas, Nassim Djebli, Clémence Rauch, Aurélie Brunet, Fabrice Hurbin, Jean-Marie Martinez, David Fabre
BACKGROUND: Alirocumab, a human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly lowers low-density lipoprotein cholesterol levels. OBJECTIVE: This analysis aimed to develop and qualify a population pharmacokinetic/pharmacodynamic model for alirocumab based on pooled data obtained from 13 phase I/II/III clinical trials. METHODS: From a dataset of 2799 individuals (14,346 low-density lipoprotein-cholesterol values), individual pharmacokinetic parameters from the population pharmacokinetic model presented in Part I of this series were used to estimate alirocumab concentrations...
May 3, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29725996/population-pharmacokinetic-analysis-of-alirocumab-in-healthy-volunteers-or-hypercholesterolemic-subjects-using-a-michaelis-menten-approximation-of-a-target-mediated-drug-disposition-model-support-for-a-biologics-license-application-submission-part-i
#11
Jean-Marie Martinez, Aurélie Brunet, Fabrice Hurbin, A Thomas DiCioccio, Clémence Rauch, David Fabre
BACKGROUND: Alirocumab, a human monoclonal antibody, inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) to significantly reduce low-density lipoprotein cholesterol levels; pharmacokinetics (PK) are governed by non-linear, target-mediated drug disposition (TMDD). OBJECTIVES: We aimed to develop and qualify a population PK (PopPK) model to characterize the PK profile of alirocumab, evaluate the impact of covariates on alirocumab PK and on individual patient exposures, and estimate individual predicted concentrations for a subsequent PK/pharmacodynamic (PD) analysis...
May 3, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29704107/choosing-the-allometric-exponent-in-covariate-model-building
#12
Jaydeep Sinha, Hesham S Al-Sallami, Stephen B Duffull
BACKGROUND: Allometric scaling is often used to describe the covariate model linking total body weight (WT) to clearance (CL); however, there is no consensus on how to select its value. OBJECTIVES: The aims of this study were to assess the influence of between-subject variability (BSV) and study design on (1) the power to correctly select the exponent from a priori choices, and (2) the power to obtain unbiased exponent estimates. METHODS: The influence of WT distribution range (randomly sampled from the Third National Health and Nutrition Examination Survey, 1988-1994 [NHANES III] database), sample size (N = 10, 20, 50, 100, 200, 500, 1000 subjects), and BSV on CL (low 20%, normal 40%, high 60%) were assessed using stochastic simulation estimation...
April 27, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29691814/correction-to-effect-of-age-related-factors-on-the-pharmacokinetics-of-lamotrigine-and-potential-implications-for-maintenance-dose-optimisation-in-future-clinical-trials
#13
Sven C van Dijkman, Nico C B de Jager, Willem M Rauwé, Meindert Danhof, Oscar Della Pasqua
Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Dose Optimisation in Epilepsy Patients should read.
April 25, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29682695/two-decades-long-journey-from-riluzole-to-edaravone-revisiting-the-clinical-pharmacokinetics-of-the-only-two-amyotrophic-lateral-sclerosis-therapeutics
#14
REVIEW
Ranjeet Prasad Dash, R Jayachandra Babu, Nuggehally R Srinivas
The recent approval of edaravone has provided an intravenous option to treat amyotrophic lateral sclerosis (ALS) in addition to the existing oral agent, riluzole. The present work was primarily undertaken to provide a comprehensive clinical pharmacokinetic summary of the two approved ALS therapeutics. The key objectives of the review were to (i) tabulate the clinical pharmacokinetics of riluzole and edaravone with emphasis on absorption, distribution, metabolism and excretion (ADME) properties; (ii) provide a comparative scenario of the pharmacokinetics of the two drugs wherever possible; and (iii) provide perspectives and introspection on the gathered clinical pharmacokinetic data of the two drugs with appropriate conjectures to quench scientific curiosity...
April 23, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29679234/clinical-pharmacokinetics-and-dose-recommendations-for-posaconazole-in-infants-and-children
#15
Sophida Boonsathorn, Iek Cheng, Frank Kloprogge, Carlos Alonso, Charmion Lee, Bilyana Doncheva, John Booth, Robert Chiesa, Adam Irwin, Joseph F Standing
OBJECTIVES: The objectives of this study were to investigate the population pharmacokinetics of posaconazole in immunocompromised children, evaluate the influence of patient characteristics on posaconazole exposure and perform simulations to recommend optimal starting doses. METHODS: Posaconazole plasma concentrations from paediatric patients undergoing therapeutic drug monitoring were extracted from a tertiary paediatric hospital database. These were merged with covariates collected from electronic sources and case-note reviews...
April 20, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29675639/pharmacokinetic-pharmacodynamic-modeling-in-pediatric-drug-development-and-the-importance-of-standardized-scaling-of-clearance
#16
REVIEW
Eva Germovsek, Charlotte I S Barker, Mike Sharland, Joseph F Standing
Pharmacokinetic/pharmacodynamic (PKPD) modeling is important in the design and conduct of clinical pharmacology research in children. During drug development, PKPD modeling and simulation should underpin rational trial design and facilitate extrapolation to investigate efficacy and safety. The application of PKPD modeling to optimize dosing recommendations and therapeutic drug monitoring is also increasing, and PKPD model-based dose individualization will become a core feature of personalized medicine. Following extensive progress on pediatric PK modeling, a greater emphasis now needs to be placed on PD modeling to understand age-related changes in drug effects...
April 19, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29671202/pharmacokinetics-and-pharmacodynamics-of-once-weekly-somapacitan-in-children-and-adults-supporting-dosing-rationales-with-a-model-based-analysis-of-three-phase-i-trials
#17
Rasmus Vestergaard Juul, Michael Højby Rasmussen, Henrik Agersø, Rune Viig Overgaard
BACKGROUND: Somapacitan, a long-acting growth hormone (GH) derivative, has been well-tolerated in children with GH deficiency (GHD) and adults (healthy and adult GHD), in phase I, single- and multiple-dose trials, respectively, and has pharmacokinetic and pharmacodynamic properties supporting a once-weekly dosing regimen. OBJECTIVE: In the absence of a multiple-dose phase I trial in children with GHD, the aim was to develop a pharmacokinetic/pharmacodynamic model to predict somapacitan exposure and insulin-like growth factor-I (IGF-I) response after once-weekly multiple doses in both children and adults with GHD...
April 18, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29667038/complex-drug-drug-gene-disease-interactions-involving-cytochromes-p450-systematic-review-of-published-case-reports-and-clinical-perspectives
#18
REVIEW
Flavia Storelli, Caroline Samer, Jean-Luc Reny, Jules Desmeules, Youssef Daali
Drug pharmacokinetics (PK) is influenced by multiple intrinsic and extrinsic factors, among which concomitant medications are responsible for drug-drug interactions (DDIs) that may have a clinical relevance, resulting in adverse drug reactions or reduced efficacy. The addition of intrinsic factors affecting cytochromes P450 (CYPs) activity and/or expression, such as genetic polymorphisms and diseases, may potentiate the impact and clinical relevance of DDIs. In addition, greater variability in drug levels and exposures has been observed when such intrinsic factors are present in addition to concomitant medications perpetrating DDIs...
April 17, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29663259/clinical-investigation-of-coproporphyrins-as-sensitive-biomarkers-to-predict-mild-to-strong-oatp1b-mediated-drug-drug-interactions
#19
Annett Kunze, Emmanuel Njumbe Ediage, Lieve Dillen, Mario Monshouwer, Jan Snoeys
INTRODUCTION: Coproporphyrin (CP) I and III have recently been proposed as endogenous clinical biomarkers to predict organic anion-transporting polypeptide 1B (OATP1B)-mediated drug-drug interactions (DDIs). In the present study, we first investigated the in vitro selectivity of CPI and CPIII towards drug uptake and efflux transporters. We then assessed the in vivo biomarker sensitivity towards OATP1B inhibition. METHODS: To assess transporter selectivity, incubations with CPI and CPIII were performed in vitro, using single transporter-expressing and control systems...
April 16, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29654492/polymorphic-expression-of-ugt1a9-is-associated-with-variable-acetaminophen-glucuronidation-in-neonates-a-population-pharmacokinetic-and-pharmacogenetic-study
#20
Matthew W Linakis, Sarah F Cook, Shaun S Kumar, Xiaoxi Liu, Diana G Wilkins, Roger Gaedigk, Andrea Gaedigk, Catherine M T Sherwin, John N van den Anker
INTRODUCTION: Acetaminophen (paracetamol, APAP) is widely used as an analgesic and antipyretic drug in children and neonates. A number of enzymes contribute to the metabolism of acetaminophen, and genetic factors might be important to explain variability in acetaminophen metabolism among individuals. METHODS: The current investigation utilized a previously published parent-metabolite population pharmacokinetic model describing acetaminophen glucuronidation, sulfation, and oxidation to examine the potential role of genetic variability on the relevant metabolic pathways...
April 13, 2018: Clinical Pharmacokinetics
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