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Journal of Pharmacokinetics and Pharmacodynamics

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https://www.readbyqxmd.com/read/30218416/extrapolation-of-praziquantel-pharmacokinetics-to-a-pediatric-population-a-cautionary-tale
#1
Peter L Bonate, Tianli Wang, Paul Passier, Wilhelmina Bagchus, Howard Burt, Christian Lüpfert, Nada Abla, Jana Kovac, Jennifer Keiser
L-praziquantel (PZQ) pharmacokinetic data were analyzed from two relative bioavailability Phase 1 studies in adult, healthy subjects with two new oral dispersion tablet (ODT) formulations of L-PZQ administered under various combinations of co-administration with food, water, and/or crushing. Linear mixed effects models adequately characterized the noncompartmental estimates of the pharmacokinetic profiles in both studies. Dose, food, and formulation were found to significantly affect L-PZQ exposure in both studies...
September 14, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/30203256/abstracts-for-the-ninth-american-conference-on-pharmacometrics-acop9
#2
(no author information available yet)
No abstract text is available yet for this article.
September 10, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/30171443/correction-to-modelling-the-delay-between-pharmacokinetics-and-eeg-effects-of-morphine-in-rats-binding-kinetic-versus-effect-compartment-models
#3
Wilhelmus E A de Witte, Vivi Rottschäfer, Meindert Danhof, Piet H van der Graaf, Lambertus A Peletier, Elizabeth C M de Lange
The original version of this article was published open access. Unfortunately, due to a technical issue, the copyright holder name in the online version (HTML and XML) is incorrectly published as "Springer Science+Business Media, LLC, part of Springer Nature 2018". Instead, it should be "The Author(s) 2018".
August 31, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/30069744/physiologically-based-pharmacokinetic-and-pharmacodynamic-models-for-gemcitabine-and-birinapant-in-pancreatic-cancer-xenografts
#4
Xu Zhu, Sheryl Trueman, Robert M Straubinger, William J Jusko
The anticancer effects of combined gemcitabine and birinapant were demonstrated as synergistic in PANC-1 cells in vitro. In this study, pharmacokinetic information derived from experiments and the literature was utilized to develop full physiologically-based pharmacokinetic (PBPK) models that characterize individual drugs. The predicted intra-tumor drug concentrations were used as the driving force within a linked PBPK/PD model for treatment-mediated changes in tumor volume in a xenograft mouse model. The efficacy of the drug combination in vivo was evaluated mathematically as exhibiting additivity...
August 1, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/30046963/data-standards-for-model-informed-drug-development-an-isop-initiative
#5
Andrijana Radivojevic, Brian Corrigan, Nicholas Downie, Robert Fox, Jill Fiedler-Kelly, Huan Liu, Murad Melhem, David Radke, Peter Schaefer, Jing Su, Maciej J Swat, Nathan S Teuscher, Neelima Thanneer, Alice Zong, Justin J Wilkins
No abstract text is available yet for this article.
July 25, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/30043250/an-item-response-theory-based-integrated-model-of-headache-nausea-photophobia-and-phonophobia-in-migraine-patients
#6
Dongwoo Chae, Kyungsoo Park
This study developed an integrated model of severity scores of migraine headache and the incidence of nausea, photophobia, and phonophobia to predict the natural time course of migraine symptoms, which are likely to occur by a common disease progression mechanism. Data were acquired from two phase 3 clinical trials conducted during the development of eletriptan. Only the placebo arm was used for analysis. A conventional proportional odds model was compared with an item response theory (IRT) based approach. Results suggested that the IRT based approach led to a better model fit, successfully revealing the difference in relief rates among different symptoms, which was the fastest in phonophobia and the slowest in headache...
July 24, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29992479/population-pharmacokinetics-pharmacodynamics-of-oral-everolimus-in-patients-with-seizures-associated-with-tuberous-sclerosis-complex
#7
François Pierre Combes, Guillaume Baneyx, Neva Coello, Penny Zhu, William Sallas, Hequn Yin, Jerry Nedelman
Everolimus is approved in Europe and in the USA for the adjunctive treatment of patients aged 2 years and older whose refractory partial-onset seizures, with or without secondary generalization, are associated with tuberous sclerosis complex. The objective of this analysis was to establish a population pharmacokinetic (PK)/pharmacodynamic model describing the relationship between seizure frequency and everolimus exposure to confirm the recommended target concentration range of 5-15 ng/mL. The PK model was a two-compartment model with first order absorption and clearance...
July 10, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29987574/mathematical-analysis-and-drug-exposure-evaluation-of-pharmacokinetic-models-with-endogenous-production-and-simultaneous-first-order-and-michaelis-menten-elimination-the-case-of-single-dose
#8
Xiaotian Wu, Fahima Nekka, Jun Li
Drugs with an additional endogenous source often exhibit simultaneous first-order and Michaelis-Menten elimination and are becoming quite common in pharmacokinetic modeling. In this paper, we investigate the case of single dose intravenous bolus administration for the one-compartment model. Relying on a formerly introduced transcendent function, we were able to analytically express the concentration time course of this model and provide the pharmacokinetic interpretation of its components. Using the concept of the corrected concentration, the mathematical expressions for the partial and total areas under the concentration time curve (AUC) were also given...
July 9, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29961161/joint-longitudinal-model-development-application-to-exposure-response-modeling-of-acr-and-das-scores-in-rheumatoid-arthritis-patients-treated-with-sirukumab
#9
Chuanpu Hu, Yan Xu, Yanli Zhuang, Benjamin Hsu, Amarnath Sharma, Zhenhua Xu, Liping Zhang, Honghui Zhou
Exposure-response modeling is important to optimize dose and dosing regimen in clinical drug development. The joint modeling of multiple endpoints is made possible in part by recent progress in latent variable indirect response (IDR) modeling for ordered categorical endpoints. This manuscript presents the results of joint modeling of continuous and ordered categorical endpoints in the latent variable IDR modeling framework through the sharing of model parameters, with an application to the exposure-response modeling of sirukumab...
June 30, 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/30187349/the-ninth-american-conference-on-pharmacometrics-acop9
#10
(no author information available yet)
No abstract text is available yet for this article.
October 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29948795/modeling-and-simulations-to-support-dose-selection-for-eslicarbazepine-acetate-therapy-in-pediatric-patients-with-partial-onset-seizures
#11
Soujanya Sunkaraneni, Elizabeth Ludwig, Jill Fiedler-Kelly, Seth Hopkins, Gerald Galluppi, David Blum
Modeling and simulations were used to support body weight-based dose selection for eslicarbazepine acetate (ESL) in pediatric subjects aged 4-17 years with partial-onset seizures. A one-compartment pediatric population pharmacokinetic model with formulation-specific first-order absorption, first-order elimination, and weight-based allometric scaling of clearance and distribution volume was developed with PK data from subjects 2-18 years of age treated with ESL 5-30 mg/kg/day. Covariate analysis was performed to quantify the effects of key demographic and clinical covariates (including body weight and concomitant use of carbamazepine, levetiracetam, and phenobarbital-like antiepileptic drugs [AEDs]) on variability in PK parameters...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29948794/reduced-and-optimized-trial-designs-for-drugs-described-by-a-target-mediated-drug-disposition-model
#12
A Brekkan, S Jönsson, M O Karlsson, A C Hooker
Monoclonal antibodies against soluble targets are often rich and include the sampling of multiple analytes over a lengthy period of time. Predictive models built on data obtained in such studies can be useful in all drug development phases. If adequate model predictions can be maintained with a reduced design (e.g. fewer samples or shorter duration) the use of such designs may be advocated. The effect of reducing and optimizing a rich design based on a published study for Omalizumab (OMA) was evaluated as an example...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29777407/modelling-the-delay-between-pharmacokinetics-and-eeg-effects-of-morphine-in-rats-binding-kinetic-versus-effect-compartment-models
#13
Wilhelmus E A de Witte, Vivi Rottschäfer, Meindert Danhof, Piet H van der Graaf, Lambertus A Peletier, Elizabeth C M de Lange
Drug-target binding kinetics (as determined by association and dissociation rate constants, kon and koff ) can be an important determinant of the kinetics of drug action. However, the effect compartment model is used most frequently instead of a target binding model to describe hysteresis. Here we investigate when the drug-target binding model should be used in lieu of the effect compartment model. The utility of the effect compartment (EC), the target binding kinetics (TB) and the combined effect compartment-target binding kinetics (EC-TB) model were tested on either plasma (ECPL , TBPL and EC-TBPL ) or brain extracellular fluid (ECF) (ECECF , TBECF and EC-TBECF ) morphine concentrations and EEG amplitude in rats...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29725796/multiscale-systems-pharmacological-analysis-of-everolimus-action-in-hepatocellular-carcinoma
#14
Anusha Ande, Maher Chaar, Sihem Ait-Oudhia
Dysregulation of mTOR pathway is common in hepatocellular carcinoma (HCC). A translational quantitative systems pharmacology (QSP), pharmacokinetic (PK), and pharmacodynamic (PD) model dissecting the circuitry of this pathway was developed to predict HCC patients' response to everolimus, an mTOR inhibitor. The time course of key signaling proteins in the mTOR pathway, HCC cells viability, tumor volume (TV) and everolimus plasma and tumor concentrations in xenograft mice, clinical PK of everolimus and progression free survival (PFS) in placebo and everolimus-treated patients were extracted from literature...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29704219/receptor-gene-protein-mediated-signaling-connects-methylprednisolone-exposure-to-metabolic-and-immune-related-pharmacodynamic-actions-in-liver
#15
Vivaswath S Ayyar, Siddharth Sukumaran, Debra C DuBois, Richard R Almon, Jun Qu, William J Jusko
A multiscale pharmacodynamic model was developed to characterize the receptor-mediated, transcriptomic, and proteomic determinants of corticosteroid (CS) effects on clinically relevant hepatic processes following a single dose of methylprednisolone (MPL) given to adrenalectomized (ADX) rats. The enhancement of tyrosine aminotransferase (TAT) mRNA, protein, and enzyme activity were simultaneously described. Mechanisms related to the effects of MPL on glucose homeostasis, including the regulation of CCAAT-enhancer binding protein-beta (C/EBPβ) and phosphoenolpyruvate carboxykinase (PEPCK) as well as insulin dynamics were evaluated...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29680872/projected-24-hour-post-dose-ocular-itching-scores-post-treatment-with-olopatadine-0-7-versus-0-2
#16
Matthew L Fidler, Abayomi Ogundele, David Covert, Ramesh Sarangapani
Olopatadine is an antihistamine and mast cell stabilizer used for treating allergic conjunctivitis. Olopatadine 0.7% has been recently approved for daily dosing in the US, which supersedes the previously approved 0.2% strength. The objective of this analysis was to characterize patients who have better itching relief at 24 h when taking olopatadine 0.7% treatment instead of olopatadine 0.2% (in terms of proportions of responses) and relate this to the severity of baseline itching as an indirect metric of a patient's sensitivity to antihistamines...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29671170/physiologically-based-modeling-and-interspecies-prediction-of-paclitaxel-pharmacokinetics
#17
Xiaowei Zang, Leonid Kagan
The objective was to develop a physiologically-based pharmacokinetic (PBPK) model to characterize the whole-body disposition of paclitaxel (formulated in Cremophor EL and ethanol-Taxol® ) in mice and to evaluate the utility of this model for predicting pharmacokinetics in other species. Published studies that reported paclitaxel plasma and tissue concentration-time data following single intravenous bolus administration of Taxol® to mice were used; and the PBPK model included plasma, liver, lungs, kidneys, spleen, heart, gastrointestinal tract, and remainder compartments...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29582349/model-reduction-in-mathematical-pharmacology-integration-reduction-and-linking-of-pbpk-and-systems-biology-models
#18
Thomas J Snowden, Piet H van der Graaf, Marcus J Tindall
In this paper we present a framework for the reduction and linking of physiologically based pharmacokinetic (PBPK) models with models of systems biology to describe the effects of drug administration across multiple scales. To address the issue of model complexity, we propose the reduction of each type of model separately prior to being linked. We highlight the use of balanced truncation in reducing the linear components of PBPK models, whilst proper lumping is shown to be efficient in reducing typically nonlinear systems biology type models...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29549540/a-comprehensive-evaluation-of-exposure-response-relationships-in-clinical-trials-application-to-support-guselkumab-dose-selection-for-patients-with-psoriasis
#19
Chuanpu Hu, Zhenling Yao, Yang Chen, Bruce Randazzo, Liping Zhang, Zhenhua Xu, Amarnath Sharma, Honghui Zhou
Guselkumab, a human IgG1 monoclonal antibody that blocks interleukin-23, has been evaluated in one Phase 2 and two Phase 3 trials in patients with moderate-to-severe psoriasis, in which disease severity was assessed using Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) scores. Through the application of landmark and longitudinal exposure-response (E-R) modeling analyses, we sought to predict the guselkumab dose-response (D-R) relationship using data from 1459 patients who participated in these trials...
August 2018: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29943290/physiologically-based-pharmacokinetic-quantitative-systems-toxicology-and-safety-pbpk-qsts-modeling-approach-applied-to-predict-the-variability-of-amitriptyline-pharmacokinetics-and-cardiac-safety-in-populations-and-in-individuals
#20
Zofia Tylutki, Aleksander Mendyk, Sebastian Polak
The physiologically based pharmacokinetic (PBPK) models allow for predictive assessment of variability in population of interest. One of the future application of PBPK modeling is in the field of precision dosing and personalized medicine. The aim of the study was to develop PBPK model for amitriptyline given orally, predict the variability of cardiac concentrations of amitriptyline and its main metabolite-nortriptyline in populations as well as individuals, and simulate the influence of those xenobiotics in therapeutic and supratherapeutic concentrations on human electrophysiology...
June 25, 2018: Journal of Pharmacokinetics and Pharmacodynamics
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