Results 131 to 140 of about 1,942 (154)

A Vector Theory of Assessing Clinical Trials: An Application to Bioequivalence. [PDF]

J Cardiovasc Dev Dis
Karalis VD.
europepmc   +1 more source

PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report. [PDF]

Mol Pharm
Heimbach T, Musuamba Tshinanu F, Raines K, Borges L, Kijima S, Malamatari M, Moody R, Veerasingham S, Seo P, Turner D, Fang L, Stillhart C, Bransford P, Ren X, Patel N, Sperry D, Chen H, Rostami-Hodjegan A, Lukacova V, Sun D, Nguefack JF, Carducci T, Grimstein M, Pepin X, Jamei M, Stamatopoulos K, Li M, Sanghavi M, Tannergren C, Mandula H, Zhao Z, Ju TR, Wagner C, Arora S, Wang M, Rullo G, Mitra A, Kollipara S, Chirumamilla SK, Polli JE, Mackie C.   +40 more
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Leveraging Model Master Files for Long-Acting Injectables. [PDF]

Pharm Res
Gong Y, Hopefl R, Li T, Hooker AC, Silva DA, Alam K, Ducharme M, Moody R, Saha P, Babiskin A.   +9 more
europepmc   +1 more source

Modeling and Simulation of Acetaminophen Pharmacokinetics and Hepatic Biomarkers After Overdoses of Extended-Release and Immediate-Release Formulations in Healthy Adults Using the Quantitative Systems Toxicology Software Platform DILIsym. [PDF]

CPT Pharmacometrics Syst Pharmacol
Beaudoin JJ, Yang K, Howell BA, Kenz Z, Lakhani VV, Woodhead JL, Lai JCK, Gelotte CK, Sista S, Atillasoy E.   +9 more
europepmc   +1 more source

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria
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Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling

The AAPS Journal, 2023
In lieu of large bioequivalence studies and exposing healthy postmenopausal women to additional drug exposure for elagolix coadministered with hormonal add-back therapy, physiologically based pharmacokinetic (PBPK) modeling was used with in vitro dissolution data to test for virtual bioequivalence.
Dwaipayan Mukherjee, Mong-Jen Chen, Xi Shao, Tzuchi R. Ju, Mohamad Shebley, Patrick Marroum   +5 more
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In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population

Clinical Pharmacokinetics, 2021
Model-informed drug discovery and development (MID3) shows great advantages in facilitating drug development. A physiologically based pharmacokinetic model is one of the powerful computational approaches of MID3, and the emerging field of virtual bioequivalence is well recognized to be the future of the physiologically based pharmacokinetic model ...
Fan Zhang, Ranran Jia, Huitao Gao, Xiaofei Wu, Bo Liu, Hongyun Wang   +5 more
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Towards Virtual Bioequivalence Studies for Oral Dosage Forms Containing Poorly Water-Soluble Drugs: A Physiologically Based Biopharmaceutics Modeling (PBBM) Approach

Journal of Pharmaceutical Sciences, 2022
The objective of the present study was to develop a physiologically based biopharmaceutics (PBBM) approach to predict the bioequivalence of dosage forms containing poorly soluble drugs. Aripiprazole and enzalutamide were used as model drugs. Variations in the gastrointestinal (GI) physiological parameters of fasted humans were taken into consideration ...
Atsushi, Kambayashi, Jennifer B, Dressman   +1 more
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Predicting the Pharmacokinetics of Orally Administered Drugs across BCS Classes 1–4 by Virtual Bioequivalence Model

Molecular Pharmaceutics, 2022
To evaluate the influence of solubility and permeability on the pharmacokinetic prediction performance of orally administered drugs using avirtual bioequivalence (VBE) model, a total of 23 orally administered drugs covering Biopharmaceutics Classification System (BCS) classes 1-4 were selected. A VBE model (i.e., a physiologically based pharmacokinetic
Fan Zhang, Xiaofei Wu, Keheng Wu, Mengyang Yu, Bo Liu, Hongyun Wang   +5 more
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