Results 31 to 40 of about 690 (120)

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

A Physiologically Based Pharmacokinetic Model for Studying the Biowaiver Risk of Biopharmaceutics Classification System Class I Drugs With Rapid Elimination: Dexketoprofen Trometamol Case Study

Frontiers in Pharmacology, 2022
Biowaiver based on the biopharmaceutics classification system (BCS) has been widely used in the global market for the approval of new generic drug products to avoid unnecessary in vivo bioequivalence (BE) studies.
Xian Zhang, Xuxiao Ye, Kuan Hu, Wenping Li, Wenqian Li, Qingqing Xiao, Lin Chen, Jin Yang   +7 more
doaj   +1 more source

Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study

Clinical and Translational Science, 2023
In vitro‐in vivo correlation (IVIVC) allows prediction of the in vivo performance of a pharmaceutical product based on its in vitro drug release profiles and can be used to reduce the number of bioequivalence (BE) studies during product development, and ...
Jiaying Wang, Jinliang Chen, Lu Wang, Dandan Yang, Rong Shao, Honggang Lou, Zourong Ruan, Bo Jiang   +7 more
doaj   +1 more source

A Rational Approach to Predicting Immediate Release Formulation Behavior in Multiple Gastric Motility Patterns: A Combination of a Biorelevant Apparatus, Design of Experiments, and Machine Learning

Pharmaceutics, 2023
Gastric mechanical stress often impacts drug dissolution from solid oral dosage forms, but in vitro experiments cannot recreate the substantial variability of gastric motility in a reasonable time.
Marcela Staniszewska, Michał Romański, Sebastian Polak, Grzegorz Garbacz, Justyna Dobosz, Daria Myslitska, Svitlana Romanova, Jadwiga Paszkowska, Dorota Danielak   +8 more
doaj   +1 more source

Application of physiologically based biopharmaceutics modeling to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol

CPT: Pharmacometrics & Systems Pharmacology, 2021
Merck KGaA observed slight differences in the dissolution of Concor® (bisoprolol) batches over the years. The purpose of this work was to assess the impact of in vitro dissolution on the simulated pharmacokinetics of bisoprolol using in vitro–in vivo ...
Joyce S. Macwan, Grace Fraczkiewicz, Mauro Bertolino, Phillip Krüger, Sheila‐Annie Peters   +4 more
doaj   +1 more source

Population Pharmacokinetic Method to Predict Within-Subject Variability Using Single-Period Clinical Data

Pharmaceuticals, 2021
Sample sizes for single-period clinical trials, including pharmacokinetic studies, are statistically determined by within-subject variability (WSV).
Won-ho Kang, Jae-yeon Lee, Jung-woo Chae, Kyeong-Ryoon Lee, In-hwan Baek, Min-Soo Kim, Hyun-moon Back, Sangkeun Jung, Craig Shaffer, Rada Savic, Hwi-yeol Yun   +10 more
doaj   +1 more source

Development of Extended-Release Mini-Tablets Containing Metoprolol Supported by Design of Experiments and Physiologically Based Biopharmaceutics Modeling

Pharmaceutics, 2022
The development of extended-release dosage forms with adequate drug release is a challenge for pharmaceutical companies, mainly when the drug presents high solubility, as in Biopharmaceutics Classification System (BCS) class I.
Michele Georges Issa, Natalia Vieira de Souza, Bruna Wenyi Chuang Jou, Marcelo Dutra Duque, Humberto Gomes Ferraz   +4 more
doaj   +1 more source

Formulation development, in vivo bioequivalence and pediatric PBPK modeling studies of taste-masked ciprofloxacin chewable tablets

Scientific Reports, 2023
A taste-masked chewable tablet of ciprofloxacin using ion exchange resin Kyron T-134 for enhancing compliance for the paediatric population was developed.
Muhammad Talha Usmani, Muhammad Harris Shoaib, Fahad Siddiqui, Farrukh Rafiq Ahmed, Rabia Ismail Yousuf, Muhammad Talha Saleem   +5 more
doaj   +1 more source