Results 21 to 30 of about 690 (120)

Using the Simcyp R Package for PBPK Simulation Workflows With the Simcyp Simulator [PDF]

CPT: Pharmacometrics & Systems Pharmacology
Physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) modeling aims to understand how a drug is absorbed, distributed, metabolized, excreted, and acts in a human or animal body.
Anthonia M. Onasanwo, Naresh Mittapelly, Laura Shireman, Barry Vinden, Kevin McNally, James Craig, Frederic Y. Bois   +6 more
doaj   +2 more sources

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations [PDF]

Clinical and Translational Science
The equivalence of absorption rates and extents between generic drugs and their reference formulations is crucial for ensuring therapeutic comparability.
Ting Luo, Lu Wang, Zourong Ruan, Honggang Lou, Dandan Yang, Zhiyang Wang, Pengfei Zhao, Bo Jiang   +7 more
doaj   +2 more sources

Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling [PDF]

AAPS Journal, 2022
Margareta Bego, Nikunjkumar Patel, Rodrigo Cristofoletti   +2 more
exaly   +2 more sources

Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 1. Impact of particle Size on Formulation Variability. [PDF]

AAPS J
This study presents a workflow for virtual bioequivalence (VBE) assessment of 3-month paliperidone palmitate (PP) long-acting injectable (LAI) suspensions using a novel physiologically based pharmacokinetic (PBPK) model. The mechanistic absorption and PBPK model was implemented in the Simcyp® Simulator and calibrated against individual concentration ...
Morris NM, Djehizian A, Mittapelly N, Telaprolu KC, Holland BW, McNally K, Polak S, Jamei M, Alam K, Tsakalozou E, Donnelly M, Feng K, Bois FY.   +12 more
europepmc   +10 more sources

Virtual Bioequivalence Assessment of Long-Acting Injectable Suspensions Using PBPK Modeling: Part 2. Type I Error and Safe Space Analyses. [PDF]

AAPS J, 2023
The recent emergence of virtual comparative trials, in particular for virtual bioequivalence (VBE) assessment, implies a formalization of their analyses. In recent VBE assessments, pharmacokinetic models informed with in vitro data and verified with small clinical trials data were used to simulate otherwise unfeasibly large trials. Simulated VBE trials
Morris NM, Jamei M, Alam K, Tsakalozou E, Donnelly M, Feng K, Bois FY.   +6 more
europepmc   +6 more sources

Application in silico Modeling Simulation in Bioequivalence Studies: A Review

Journal of Food and Pharmaceutical Sciences, 2023
Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies ...
Sekar Ayu Pawestri
doaj   +1 more source

VIRTUAL BIOEQUIVALENCE IN PHARMACEUTICALS: CURRENT STATUS AND FUTURE PROSPECTS

International Journal of Applied Pharmaceutics, 2023
Virtual bioequivalence studies (VBE) can assess the similarity and potential differences in pharmacokinetic and clinical performance between test and reference formulations based on the translational relationship between in vitro, in silico, and in vivo.
SOWMYA C., ABRAR AHMED H., SURIYA PRAKAASH K. K.   +2 more
openaire   +1 more source

Bioequivalence study of ipratropium bromide inhalation aerosol using PBPK modelling

Frontiers in Medicine, 2023
AimsSystemic pharmacokinetic (PK) studies can reflect the overall exposure of orally inhaled drug Products (OIDPs) in the blood after inhalation into the lung and can be used to evaluate the bioequivalence of test and reference products.
Jisheng Zhang, Keheng Wu, Bo Liu, Shuguang Hou, Xue Li, Xiang Ye, Jack Liu, Qing He   +7 more
doaj   +1 more source

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

CPT: Pharmacometrics & Systems Pharmacology, 2023
On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence ...
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao   +17 more
doaj   +1 more source

Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets

Pharmaceutics, 2023
This study aimed to develop a biopredictive dissolution method for desvenlafaxine ER tablets using design of experiments (DoE) and physiologically based biopharmaceutics modeling (PBBM) to address the challenge of developing generic drug products by ...
Gustavo Vaiano Carapeto, Marcelo Dutra Duque, Michele Georges Issa, Humberto Gomes Ferraz   +3 more
doaj   +1 more source