Results 121 to 130 of about 8,529 (239)

Is a Clinical Trial With a Non‐Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK

Clinical Pharmacology &Therapeutics, Volume 120, Issue 1, Page 203-213, July 2026.
Although physiologically based pharmacokinetic (PBPK) modeling is increasingly being used to support oral drug formulation bridging, the acceptance by regulatory agencies is low. One of the primary concerns is the absence of clinical pharmacokinetic (PK) data from a non‐bioequivalent (non‐BE) batch during model validation.
Jin Dong, Andrea Moir, Xavier Pepin, Elizabeth Lowe, Sandy Hopkins, Weifeng Tang, Diansong Zhou   +6 more
wiley   +1 more source

Utilizing Physiologically Based Pharmacokinetic Models to Support Rational Medication in Chinese Elderly Population

Drug Design, Development and Therapy
Xiaofei Wu, Ziyang Wang, Shupeng Liu, Hongyun Wang Clinical Pharmacology Research Center, Peking Union Medical College Hospital, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug ...
Wu X, Wang Z, Liu S, Wang H
doaj  

Middle‐Out Physiologically Based Pharmacokinetic Modeling to Support Pediatric Dosing Recommendation for Alectinib

CPT: Pharmacometrics & Systems Pharmacology
Adult patients with anaplastic lymphoma kinase positive (ALK+) advanced non–small‐cell lung cancer (NSCLC) are treated with 600 mg alectinib twice daily (BID) as first‐line treatment.
Tamara vanDonge, Elena Guerini, Amaury O'Jeanson, Neil Parrott, Clare Devlin, Cordula Stillhart, Nassim Djebli   +6 more
doaj   +1 more source

omrichfield/PACE-PBPK-Monte-Carlo__public: PACE-PBPK-Monte-Carlo__public

Public Physiologically Based Pharmacokinetic Model of polyamine coester ...
omrichfield
core   +1 more source

Exploring Tafamidis Effects Through PBPK-QSP Modelling

Pharmaceutics
Background/Objectives: Tafamidis, a transthyretin kinetic stabilizer, increases circulating transthyretin levels in treated patients. While this effect is well documented, its underlying mechanism remains incompletely understood. This study aimed to evaluate the performance of a Physiologically Based Pharmacokinetic (PBPK) model performance and to ...
Seweryn Ulaszek, Bartek Lisowski, Barbara Wiśniowska, Sebastian Polak   +3 more
openaire   +4 more sources

PBPK parameters for the compounds considered.

, 2014
The table lists the PBPK model parameters for CFDA SE, midazolam, and spiramycin used in our simulations, including literature sources. Molecular weight MW, fraction unbound and lipophilicity are used to calculate the partition coefficients and ...
Tobias Preusser (535384), Lars Ole Schwen (535380), Fabian Kiessling (535383), Lars Kuepfer (31319), Christoph Niederalt (535381), Felix Gremse (535382), Markus Krauss (124200), Andrea Schenk (530847)   +7 more
core   +1 more source

Polymyxin B Intravenous Administration Strategy Guided by Minimum Inhibitory Concentration in Critically Ill Patients With Pulmonary Infection: Insights From PBPK Modeling

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 7, July 2026.
PBPK/PD modeling and clinical retrospective validation of intravenous polymyxin B in critically ill patients with pulmonary infection. ABSTRACT Intravenous polymyxin B (PMB) is widely used for treating drug‐resistant gram‐negative pneumonia, though its efficacy in pulmonary infections is considered limited.
Shengnan Zhang, Nan Yang, Ruwei Yang, Yuanfang Qin, Tingting Wu, Cuifang Wu, Yueliang Xie, Jingjing Liu, Chun Liu, Qi Pei   +9 more
wiley   +1 more source

PBPK model of the kinetics of BaP and 3-OHBaP in humans.

, 2014
PBPK model of the kinetics of BaP and 3-OHBaP in humans.
Roberto Heredia Ortiz (599972), Anne Maître (481841), Michèle Bouchard (527826), Damien Barbeau (599973), Michel Lafontaine (599974)   +4 more
core   +1 more source

Accelerating Subcutaneous Drug Development: A Mechanistic Absorption Model for the Open Systems Pharmacology Framework

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 7, July 2026.
ABSTRACT This study describes the implementation of a mechanistic subcutaneous (SC) injection model for the Open Systems Pharmacology platform. As the SC route of administration is gaining increased popularity, there is a growing need for tools to predict, analyze, and understand the SC absorption process and the mechanisms involved.
Moriah Pellowe, Ilse Dubbelboer, Erik Sjögren   +2 more
wiley   +1 more source

인체 PBPK 모델을 이용한 DEHP의 노출량 평가

, 2013
학위논문 (석사)-- 서울대학교 보건대학원 : 환경보건학과, 2013. 8. 김성균.Di(2-ethylhexyl)phthalate (DEHP)는 PVC 등 플라스틱 제품의 대표적인 가소제로 광범위하게 사용되는 프탈레이트의 한 종류이다. 본 연구에서는 수용체 장기(organs)의 생리학적 구조와 기능을 바탕으로 화학물질의 흡수 (absorption), 분포 (distribution), 대사 (metabolism) 및 배설 (excretion)을 예측하는
김경민
core