Results 1 to 10 of about 694 (113)

Adult and pediatric physiologically‐based biopharmaceutics modeling to explain lamotrigine immediate release absorption process [PDF]

CPT: Pharmacometrics & Systems Pharmacology, 2023
Physiologically‐based biopharmaceutics modeling (PBBM) has potential to accelerate the development of new drug and formulations. An important application of PBBM is for special populations such as pediatrics that have pharmacokinetics dependent on the ...
Edilainy Rizzieri Caleffi‐Marchesini, Amanda Antunes Herling, Julia Macente, Rodolfo Hernandes Bonan, Priscila deFreitas Lima, Rafaela Moreno, Veriano Alexandre, Nitin Bharat Charbe, Fernanda Belincanta Borghi‐Pangoni, Rodrigo Cristofoletti, Andréa Diniz   +10 more
doaj   +4 more sources

Physiologically Based Biopharmaceutics Modeling of Regional and Colon Absorption in Dogs. [PDF]

Mol Pharm, 2021
Colon absorption is a key determinant for the successful development of modified-release (MR) formulations, and the risk that colon absorption may limit the in vivo performance of an MR product can be assessed early by various in vitro tests or by preclinical in vivo regional absorption studies in dogs.
Eckernäs E, Tannergren C.
europepmc   +5 more sources

Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling [PDF]

CPT: Pharmacometrics & Systems Pharmacology
Omaveloxolone is a nuclear factor (erythroid‐derived 2)‐like 2 activator approved in the United States and the European Union for the treatment of patients with Friedreich ataxia aged ≥16 years, with a recommended dosage of 150 mg orally once daily on an
Xavier J. H. Pepin, Scott M. Hynes, Hamim Zahir, Deborah Walker, Lois Q. Semmens, Sandra Suarez‐Sharp   +5 more
doaj   +4 more sources

Physiologically Based Biopharmaceutics Model of Apixaban for Biopharmaceutics Risk Assessment [PDF]

Pharmaceutics
Background/Objectives: This study applies a Physiologically Based Biopharmaceutics Modeling (PBBM) framework to predict the bioavailability (BA) and bioequivalence (BE) of apixaban, a borderline BCS Class III/IV drug.
Paulo Paixão, Zvonimir Petric, José A. G. Morais   +2 more
doaj   +4 more sources

Physiologically Based Biopharmaceutics Modeling of Food Effect for Basmisanil: A Retrospective Case Study of the Utility for Formulation Bridging [PDF]

Pharmaceutics, 2023
Basmisanil, is a lipophilic drug substance, exhibiting poor solubility and good permeability (BCS class 2). A validated physiologically based biopharmaceutics model (PBBM) has been previously described for tablets dosed in the fed state.
Tejashree Belubbi, Davide Bassani, Cordula Stillhart, Neil Parrott   +3 more
doaj   +4 more sources

Physiologically-Based Biopharmaceutics Modeling for Ibuprofen: Identifying Key Formulation Parameter and Virtual Bioequivalence Assessment [PDF]

Pharmaceutics
Background: Physiologically based pharmacokinetic (PBPK) modeling for biopharmaceutics applications (i.e., physiologically based biopharmaceutics modeling (PBBM)) enables mechanistic modeling from dissolution to absorption and disposition, facilitating ...
Javier Zarzoso-Foj, Marina Cuquerella-Gilabert, Matilde Merino-Sanjuan, Javier Reig-Lopez, Víctor Mangas-Sanjuán, Alfredo Garcia-Arieta   +5 more
doaj   +5 more sources

Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report. [PDF]

Mol Pharm
This report summarizes the proceedings for Day 3 of the workshop titled "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". This day focused on the current and future drug product quality applications of PBBM from the innovator and generic industries as well as the ...
Tannergren C, Arora S, Babiskin A, Borges L, Chatterjee P, Cheng YH, Dallmann A, Govada A, Heimbach T, Hingle M, Kollipara S, Kotzagiorgis E, Lindahl A, Mackie C, Malamatari M, Mitra A, Moody R, Pepin X, Polli J, Raines K, Rullo G, Sanghavi M, Savkur R, Singh R, Sjögren E, Suarez-Sharp S, Thomas S, Veerasingham S, Wei K, Wu F, Xu Y, Yoon M, Rege B.   +32 more
europepmc   +5 more sources

Integrating In Vitro BE Checker with In Silico Physiologically Based Biopharmaceutics Modeling to Predict the Pharmacokinetic Profiles of Oral Drug Products [PDF]

Pharmaceutics
Objective: The objective of this study was to develop a Physiologically Based Biopharmaceutics Modeling (PBBM) framework that can predict PK profiles in humans based on data generated from the BE Checker.
Takuto Niino, Takato Masada, Toshihide Takagi, Makoto Kataoka, Hiroyuki Yoshida, Shinji Yamashita, Atsushi Kambayashi   +6 more
doaj   +4 more sources

The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development [PDF]

Arhiv za farmaciju, 2021
Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a ...
Cvijić Sandra, Ignjatović Jelisaveta, Parojčić Jelena, Ibrić Svetlana   +3 more
doaj   +3 more sources

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 [PDF]

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   +2 more sources