Healthy Volunteer Pk Models

Listing Websites about Healthy Volunteer Pk Models

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Reviewing the role of healthy volunteer studies in drug development

(3 days ago) WebPK, safety: Healthy volunteers: 24 To develop a structural PK model in healthy subjects and in patients with cancer, characterize covariate effects, and …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6278009/

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Pivotal Considerations for Optimal Deployment of Healthy …

(4 days ago) WebOpportunities for healthy volunteer clinical pharmacology studies in oncology drug development: targeted agents, immunomodulatory agents, and beyond

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

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A Population Pharmacokinetic Model of Vonoprazan: Evaluating …

(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 …

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

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Population pharmacokinetic analysis of sparsentan in healthy …

(1 days ago) WebBlood samples were collected from 236 healthy volunteers, 16 subjects with hepatic impairment, and 194 primary and genetic FSGS patients enrolled in nine studies ranging …

https://pubmed.ncbi.nlm.nih.gov/37221817/

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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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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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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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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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Frontiers Population pharmacokinetic analysis for dabigatran

(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 …

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

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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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Application of physiologically-based …

(3 days ago) WebThe developed PBPK models for nifedipine were verified with reported clinical study on a single-dose of 60 mg nifedipine CR tablet or 20 mg nifedipine IR tablet …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9462537/

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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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Population plasma and urine pharmacokinetics and the - Springer

(Just Now) WebOne of the most recent fosfomycin PK analyses was studied in healthy volunteers, and it was the first PK data on fosfomycin continuous infusion . However, …

https://link.springer.com/article/10.1007/s00228-023-03477-5

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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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Healthy volunteers in first‐in‐human oncology drug development …

(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 …

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

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Population pharmacokinetic/pharmacodynamic modelling of …

(1 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 …

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

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Elucidating nonlinear pharmacokinetics of telmisartan: Integration …

(5 days ago) WebIn this study, a TMDD-PBPK model considering the enterohepatic circulation of telmisartan and its metabolite, Tel-GLU, was constructed using the PK profile after a …

https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/psp4.13154

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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 520. …

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

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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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Population Pharmacokinetic/Pharmacodynamics Modeling of …

(7 days ago) WebIn conclusion, a population PK and PK/PD models of ibutilide in healthy volunteers were well developed, and the final model was applied on patients with AF …

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

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Population Pharmacokinetic–Pharmacodynamic Model of Serum …

(2 days ago) WebThe model estimated that healthy volunteers had higher baseline TTR levels compared with typical patients with hATTR and a Hill coefficient of 0.548. The …

https://www.liebertpub.com/doi/10.1089/nat.2019.0841

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Model‐Based Characterization of the - Wiley Online Library

(5 days ago) WebIn traditional drug development programs, clinical pharmacology is typically characterized through phase I studies in healthy volunteers with intensive …

https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/psp4.12139

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A physiologically based pharmacokinetic (PBPK) approach to …

(1 days ago) WebPotential differences in pharmacokinetics (PK) between healthy subjects and patients with cancer were investigated using a physiologically based pharmacokinetic approach …

https://pubmed.ncbi.nlm.nih.gov/23225350/

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PARSA ECHO: Pakistan's Journey with ECHO and Hepatitis C

(7 days ago) WebThe nine-minute documentary demonstrates how the ECHO Model transforms stressed health care systems in Pakistan, which has the world’s highest …

https://projectecho.unm.edu/story/parsa-echo-hepatitis-c/

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