Results 1 to 10 of about 23,818,397 (163)

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   +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   +5 more sources

A Mechanistic Physiologically-Based Biopharmaceutics Modeling (PBBM) Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP [PDF]

Pharmaceutics, 2020
The application of in silico modeling to predict the in vivo outcome of an oral drug product is gaining a lot of interest. Fully relying on these models as a surrogate tool requires continuous optimization and validation.
Marival Bermejo, Bart Hens, Joseph Dickens, Deanna Mudie, Paulo Paixão, Yasuhiro Tsume, Kerby Shedden, Gordon L. Amidon   +7 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   +3 more sources

Sex‐Related Differences in Physiologically‐Based Biopharmaceutics Modeling [PDF]

CPT: Pharmacometrics & Systems Pharmacology
Physiologically based pharmacokinetic (PBPK) and physiologically‐based biopharmaceutics (PBBM) modeling are valuable tools in drug development, allowing mechanistic predictions of drug absorption and disposition.
Marianela Chavarría‐Rojas, Mubtasim Murshed, Marianela Lorier, Nikoletta Fotaki, Manuel Ibarra   +4 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   +3 more sources

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

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   +3 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   +3 more sources

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

CPT: Pharmacometrics & Systems Pharmacology
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   +2 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   +2 more sources