Results 31 to 40 of about 4,403,980 (152)

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   +7 more sources

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

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

Understanding Discordance between In Vitro Dissolution, Local Gut and Systemic Bioequivalence of Budesonide in Healthy and Crohn’s Disease Patients through PBPK Modeling

Pharmaceutics, 2023
The most common method for establishing bioequivalence (BE) is to demonstrate similarity of concentration–time profiles in the systemic circulation, as a surrogate to the site of action.
Chunyan Han, Tiancheng Sun, Siri Kalyan Chirumamilla, Frederic Y. Bois, Mandy Xu, Amin Rostami-Hodjegan   +5 more
doaj   +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

Physiologically based absorption modeling to predict the bioequivalence of two cilostazol formulations

Clinical and Translational Science, 2023
In vivo pharmacokinetic simulations and virtual bioequivalence (BE) evaluation of cilostazol have not yet been described for humans. Here, we successfully developed a physiologically based absorption model to simulate plasma concentrations of cilostazol.
Lu Wang, Pengfei Zhao, Ting Luo, Dandan Yang, Qianqian Jiang, Jinliang Chen, Honggang Lou, Zourong Ruan, Bo Jiang   +8 more
doaj   +1 more source

Population PK modelling as an alternative route to bioequivalence

British Journal of Pharmacy, 2022
Demonstrating bioequivalence (BE) is important for the development of lower-cost generic products, and also for approving post-submission manufacturing changes. However, for many complex parenteral products, BE demonstration can be very challenging.
Parmesh Gajjar, Jake Dickinson , Harri Dickinson, Linette Ruston, Hitesh B Mistry , Claire Patterson, Paul A Dickinson   +6 more
doaj   +1 more source

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

CPT: Pharmacometrics & Systems Pharmacology, 2023
On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence ...
Andrew Babiskin, Fang Wu, Youssef Mousa, Ming‐Liang Tan, Eleftheria Tsakalozou, Ross L. Walenga, Miyoung Yoon, Sam G. Raney, James E. Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao   +12 more
doaj   +1 more source