Healthy Volunteer Pk Models

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Population Pharmacokinetics and Pharmacodynamics of …

(4 days ago) WEBBenralizumab in Healthy Volunteers and Patients With Asthma B Wang1*, L Yan1, Z Yao1,2 and LK Roskos3 Benralizumab is a humanized, afucosylated, anti-interleukin-5 …

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12160

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Pivotal Considerations for Optimal Deployment of …

(4 days ago) WEBOpportunities for healthy volunteer clinical pharmacology studies in oncology drug development: targeted agents, …

https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12703

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A Population Pharmacokinetic Model of Vonoprazan: …

(9 days ago) WEBThis model was used to evaluate the impact of different covariates, including race and disease status, on vonoprazan exposure. We analyzed PK data from 746 patients and 410 healthy volunteers from …

https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.2019

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Integrated Pharmacokinetics/Pharmacodynamics Model and …

(Just Now) WEBThe final integrated PK/PD model was established by using the data of healthy subjects and ACS patients. In the process of joint analysis, due to the lack of …

https://link.springer.com/article/10.1007/s40262-022-01208-0

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Effect of autoinduction and food on the pharmacokinetics of

(Just Now) WEBThe PK data of furmonertinib and AST5902 were obtained from 38 NSCLC patients and 16 healthy volunteers receiving 20–240 mg furmonertinib in three clinical …

https://www.nature.com/articles/s41401-021-00798-y

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Pharmacokinetics, pharmacodynamics and PKPD modeling of …

(3 days ago) WEBTwelve healthy volunteers aged 18–27 years (seven men and five women) were recruited into the study following approval from the Rutgers University institutional review board (protocol ID 20160000736). For the initial PK model development, one trial of 12 human subjects receiving a single oral capsule of 4 g dose of curcumin was …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6710832/

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Population Pharmacokinetics of Brigatinib in Healthy Volunteers …

(Just Now) WEBThe current population PK analyses based on data from five clinical studies showed that plasma concentrations of brigatinib following single and repeated doses in both healthy volunteers and patients with cancer were best described by a three-compartment model with a transit compartment for absorption.

https://link.springer.com/article/10.1007/s40262-020-00929-4

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Physiologically‐Based Pharmacokinetic Model Development, …

(3 days ago) WEBAll simulations were conducted with the “Healthy volunteer” population that was built into Simcyp, with certain modifications, as mentioned in Table S1, consistent …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9828395/

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Frontiers Population pharmacokinetic analysis for …

(6 days ago) WEBThis study thoroughly explored a PK model of a single group of healthy volunteers and the PD model of healthy volunteers and patients. Due to the relative scarcity of PK samples from patients (23 …

https://www.frontiersin.org/articles/10.3389/fcvm.2022.998751/full

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Population pharmacokinetic analysis of lenvatinib in healthy …

(5 days ago) WEBpoint for this PK model development. Based on a graphical analysis of lenvatinib concentration–time profiles from phase 1 healthy volunteer studies, a three-compartment model was superior to a two-compartment model in describ-ing the concentration–time profile following single dose of lenvatinib; this was supported by a 560-point drop in

https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.12907

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A Population Pharmacokinetic Model of Vonoprazan: Evaluating …

(1 days ago) WEBHere, we report a popPK model based on pooled data sets of available pharmacokinetic (PK) studies in healthy volunteers and patients with gastroesophageal reflux disease, …

https://pubmed.ncbi.nlm.nih.gov/34935142/

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Pharmacokinetics and Pharmacodynamics of Ruxolitinib: A Review

(4 days ago) WEBHealthy volunteers Pop-PK model for MF & PV patients ; Ruxolitinib dose: 5 mg: 10 mg: 25 mg: 50 mg: 25 mg: 25 mg: 25 mg: 25 mg: 10 mg, 25 mg and 50 mg: …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10064968/

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Nonlinear Population Pharmacokinetics of Anifrolumab …

(9 days ago) WEBIn the current study, we applied the previously developed population PK model to a large body of anifrolumab PK data collected from 5 clinical trials in healthy volunteers and patients with SLE. 7-11 The …

https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.2055

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Population pharmacokinetic/pharmacodynamic …

(6 days ago) WEBThe previously published eltrombopag PK and PK/PD models for healthy volunteers, ITP patients and patients with HCV were the starting points for the present analyses 9-11. Modelling was …

https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.12244

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Predictive performance of parent-metabolite population …

(3 days ago) WEBAll models described PK in healthy volunteers, except for Dahan et al. , which studied ketamine administration in patients with complex regional pain syndrome …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275530/

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Physiologically based modelling of tranexamic acid …

(7 days ago) WEBPK data from six different single dose studies performed in healthy volunteers were utilised during model development. External validation of the model …

https://www.sciencedirect.com/science/article/pii/S0928098721001949

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Healthy volunteers in first‐in‐human oncology drug …

(6 days ago) WEB1 BACKGROUND. First-in-human (FIH) phase 1 clinical studies have traditionally been conducted in healthy volunteers (HVs) in the majority of the therapeutics areas, but for oncology drugs with …

https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.15092

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PHASE I/II CLINICAL TRIAL DESIGN AND DOSE FINDING (PART I)

(Just Now) WEBHealthy normal volunteers Primarily for PK properties Help recommend dosing frequency FOR LIFE-THREATENING DISEASES May not be ethical to use placebo control May …

https://med.stanford.edu/content/dam/sm/cisd/documents/Stanford-phase-I-II-DF-methodology-slides.pdf

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Population Pharmacokinetic/Pharmacodynamics Modeling of …

(1 days ago) WEBThe detailed demographic information about the healthy volunteers and patients is presented in Table I. Population PK Model. The PK data set consisted of …

https://www.sciencedirect.com/science/article/abs/pii/S0149291817306586

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Guideline on Pop PK reports - Adopted - European Medicines …

(Just Now) WEB(healthy volunteers or patients). It comprises the assessment of variability within the population and to Every population PK model will depend on the data and decisions …

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-results-population-pharmacokinetic-analyses_en.pdf

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