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Clinical Pharmacokinetics

Guo-Fu Li, Qing-Shan Zheng, Yichao Yu, Wei Zhong, Hong-Hao Zhou, Furong Qiu, Guangji Wang, Guo Yu, Hartmut Derendorf
BACKGROUND: The vast majority of physiological and biological data required for physiologically based predictions are primarily available in Caucasians rather than other ethnic populations, which leads to a lack of confidence in the application of physiologically based pharmacokinetic (PBPK) modeling for ethnicity-specific prediction of pharmacokinetics in the Chinese population. OBJECTIVES: In this study we recalibrate the system parameters of Chinese-specific PBPK modeling and explore for the first time the relative importance of ethnicity-specific microsomal protein per gram of liver (MPPGL), liver weight, and cytochrome P450 (CYP) 1A2 abundance to the projection of drug disposition mediated by CYP1A2 in young and elderly Chinese adults...
February 15, 2019: Clinical Pharmacokinetics
Kioa Lente Wijnsma, Rob Ter Heine, Dirk Jan A R Moes, Saskia Langemeijer, Saskia E M Schols, Elena B Volokhina, Lambertus P van den Heuvel, Jack F M Wetzels, Nicole C A J van de Kar, Roger J Brüggemann
Eculizumab is the first drug approved for the treatment of complement-mediated diseases, and current dosage schedules result in large interindividual drug concentrations. This review provides insight into the pharmacokinetic and pharmacodynamic properties of eculizumab, both for reported on-label (paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis) and off-label (hematopoietic stem cell transplantation-associated thrombotic microangiopathy) indications. Furthermore, we discuss the potential of therapeutic drug monitoring to individualize treatment and reduce costs...
February 13, 2019: Clinical Pharmacokinetics
Neil A Miller, Micaela B Reddy, Aki T Heikkinen, Viera Lukacova, Neil Parrott
Physiologically based pharmacokinetic modelling is well established in the pharmaceutical industry and is accepted by regulatory agencies for the prediction of drug-drug interactions. However, physiologically based pharmacokinetic modelling is valuable to address a much wider range of pharmaceutical applications, and a new regulatory impact is expected as its full power is leveraged. As one example, physiologically based pharmacokinetic modelling is already routinely used during drug discovery for in-vitro to in-vivo translation and pharmacokinetic modelling in preclinical species, and this leads to the application of verified models for first-in-human pharmacokinetic predictions...
February 7, 2019: Clinical Pharmacokinetics
Changcheng Shi, Yubo Xiao, Yong Mao, Jing Wu, Nengming Lin
Numerous population pharmacokinetic studies on voriconazole have been conducted in recent years. This review aimed to comprehensively summarize the population pharmacokinetic models for voriconazole and to determine which covariates have been identified and which remain to be explored. We searched the PubMed and EMBASE databases from inception to March 2018 for population pharmacokinetic analyses of voriconazole using the nonlinear mixed-effect method. A total of 16 studies were included in this review, of which 11 models were described in adult populations, four were described in pediatric populations, and the remaining study included both adult and pediatric populations...
January 28, 2019: Clinical Pharmacokinetics
Jeffry Adiwidjaja, Alan V Boddy, Andrew J McLachlan
BACKGROUND AND OBJECTIVES: Herb-drug interactions with St John's wort (SJW) have been widely studied in numerous clinical studies. The objective of this study was to develop and evaluate a physiologically based pharmacokinetic (PBPK) model for hyperforin (the constituent of SJW responsible for interactions), which has the potential to provide unique insights into SJW interactions and allow prediction of the likely extent of interactions with SJW compared to published interaction reports...
January 24, 2019: Clinical Pharmacokinetics
Stijn W van Beek, Rob Ter Heine, Ron J Keizer, Cecile Magis-Escurra, Rob E Aarnoutse, Elin M Svensson
BACKGROUND AND OBJECTIVE: This study proposes a model-informed approach for therapeutic drug monitoring (TDM) of rifampicin to improve tuberculosis (TB) treatment. METHODS: Two datasets from pulmonary TB patients were used: a pharmacokinetic study (34 patients, 373 samples), and TDM data (96 patients, 391 samples) collected at Radboud University Medical Center, The Netherlands. Nine suitable population pharmacokinetic models of rifampicin were identified in the literature and evaluated on the datasets...
January 23, 2019: Clinical Pharmacokinetics
Pieter J Colin, Karel Allegaert, Alison H Thomson, Daan J Touw, Michael Dolton, Matthijs de Hoog, Jason A Roberts, Eyob D Adane, Masato Yamamoto, Dolores Santos-Buelga, Ana Martín-Suarez, Nicolas Simon, Fabio S Taccone, Yoke-Lin Lo, Emilia Barcia, Michel M R F Struys, Douglas J Eleveld
BACKGROUND AND OBJECTIVES: Uncertainty exists regarding the optimal dosing regimen for vancomycin in different patient populations, leading to a plethora of subgroup-specific pharmacokinetic models and derived dosing regimens. We aimed to investigate whether a single model for vancomycin could be developed based on a broad dataset covering the extremes of patient characteristics. Furthermore, as a benchmark for current dosing recommendations, we evaluated and optimised the expected vancomycin exposure throughout life and for specific patient subgroups...
January 17, 2019: Clinical Pharmacokinetics
Mari Kinnunen, Panu Piirainen, Hannu Kokki, Pauliina Lammi, Merja Kokki
Global oxycodone consumption has increased sharply during the last two decades, and, in 2008, oxycodone consumption surpassed that of morphine. As oxycodone was synthesized in 1916 and taken to clinical use a year later, it has not undergone the same approval process required by today's standards. Most of the basic oxycodone pharmacokinetic (PK) data are from the 1990s and from academic research; however, a lot of additional data have been published over the last 10 years. In this review, we describe the latest oxycodone data on special populations, including neonates, children, pregnant and lactating women, and the elderly...
January 17, 2019: Clinical Pharmacokinetics
Tomoyuki Mizuno, Katja M Gist, Zhiqian Gao, Michael F Wempe, Jeffrey Alten, David S Cooper, Stuart L Goldstein, Alexander A Vinks
BACKGROUND AND OBJECTIVE: Milrinone is used for the prevention of low cardiac output syndrome in pediatric patients after cardiac surgery. Milrinone is mainly eliminated by the kidneys; however, there is limited information on milrinone pharmacokinetics in infants who have acute kidney injury (AKI). The aim of this study was to develop a milrinone population pharmacokinetic model in neonates and infants with or without AKI. The developed milrinone pharmacokinetic model was utilized for a Monte Carlo simulation analysis to identify age-appropriate dosing regimens in neonates and infants...
January 3, 2019: Clinical Pharmacokinetics
Amit Khatri, Ling Cheng, Anne Camez, Stanislav Ignatenko, Yinuo Pang, Ahmed A Othman
OBJECTIVE: The objective of this study was to characterize the effects of risankizumab on the in vivo activity of cytochrome P450 (CYP) 1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A in psoriasis patients using a cocktail approach. METHODS: Patients with moderate to severe chronic plaque psoriasis (n = 21) received single oral doses of sensitive probe substrates for CYP1A2 (caffeine 100 mg), CYP2C9 (warfarin 10 mg), CYP2C19 (omeprazole 20 mg), CYP2D6 (metoprolol 50 mg), and CYP3A (midazolam 2 mg) on day 1, followed by 12 weeks of subcutaneous risankizumab treatment of 150 mg once every 4 weeks from day 8 to day 92, and again the same cocktail of substrates on day 98...
December 21, 2018: Clinical Pharmacokinetics
Charlotte Granhall, Morten Donsmark, Thalia M Blicher, Georg Golor, Flemming L Søndergaard, Mette Thomsen, Tine A Bækdal
BACKGROUND: Oral semaglutide is a novel tablet containing the human glucagon-like peptide-1 (GLP‑1) analogue semaglutide, co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). The safety and pharmacokinetics of oral semaglutide were investigated in two randomised, double-blind, placebo-controlled trials. METHODS: In a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC...
December 18, 2018: Clinical Pharmacokinetics
Sophida Boonsathorn, Iek Cheng, Frank Kloprogge, Carlos Alonso, Charmion Lee, Bilyana Doncheva, John Booth, Robert Chiesa, Adam Irwin, Joseph F Standing
However, the Original article has been updated with the Open Access under Commercial License.
December 17, 2018: Clinical Pharmacokinetics
Eva Germovsek, Charlotte I S Barker, Mike Sharland, Joseph F Standing
The article Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance Written by Eva Germovsek,Charlotte I. S. Barker, Mike Sharland, Joseph F. Standing was incorrectly published electronically on the publisher's internet portal (currently Springer Link) on [20th April, 2018] with Open access under Non-commercial License.
December 17, 2018: Clinical Pharmacokinetics
Helena Edlund, Sun Ku Lee, Marilee A Andrew, J Greg Slatter, Sergey Aksenov, Nidal Al-Huniti
INTRODUCTION: Bruton tyrosine kinase (BTK) is a key component of B-cell receptor signalling, critical for cell proliferation. Acalabrutinib, a selective, covalent BTK inhibitor, recently received an accelerated approval in relapsed/refractory mantle cell lymphoma. This analysis characterized the population pharmacokinetics (PK) of acalabrutinib and its metabolite ACP-5862. METHODS: Data were obtained from six phase I/II trials in adult patients with B-cell malignancy and seven phase I trials in healthy volunteers...
December 17, 2018: Clinical Pharmacokinetics
Yulan Qi, Kathleen McKeever, Julie Taylor, Christine Haller, Wenjie Song, Simon A Jones, Jack Shi
Introduction section, para 3, lines 2-4 which previously read.
December 4, 2018: Clinical Pharmacokinetics
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...
January 2019: Clinical Pharmacokinetics
Marko M Sahinovic, Michel M R F Struys, Anthony R Absalom
Propofol is an intravenous hypnotic drug that is used for induction and maintenance of sedation and general anaesthesia. It exerts its effects through potentiation of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) at the GABAA receptor, and has gained widespread use due to its favourable drug effect profile. The main adverse effects are disturbances in cardiopulmonary physiology. Due to its narrow therapeutic margin, propofol should only be administered by practitioners trained and experienced in providing general anaesthesia...
December 2018: Clinical Pharmacokinetics
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...
December 2018: Clinical Pharmacokinetics
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...
December 2018: Clinical Pharmacokinetics
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...
December 2018: Clinical Pharmacokinetics
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