Results 11 to 20 of about 278 (111)

The Evolving Role of In Vitro–In Vivo Correlation in Model‐Informed Drug Development: A Multi‐Stakeholder Perspective [PDF]

CPT: Pharmacometrics & Systems Pharmacology
In vitro–in vivo correlation/relationship (IVIVC/R) models such as physiologically based biopharmaceutics modeling (PBBM) are crucial tools that link biopharmaceutical properties to clinical performance.
Marylore Chenel, Sylvain Fouliard, Emma Hansson, Karl Brendel, Matthieu Jacobs, Hans Lennernäs, Erik Sjögren, Martin Bergstrand   +7 more
doaj   +3 more sources

Model‐Informed Drug Development of a Sustained Release Formulation of Flucytosine in the Treatment of Cryptococcal Meningitis: A Case Study Using Physiologically Based Pharmacokinetic Modeling [PDF]

CPT: Pharmacometrics & Systems Pharmacology
This paper presents a case study demonstrating the application of model‐informed drug development (MIDD) and early modeling integration in the development of a sustained release (SR) formulation of flucytosine for cryptococcal meningoencephalitis (CM) in
Johanna Eriksson, Erik Sjögren, Jean‐Yves Gillon, Henri Caplain, Vishal Goyal, Vijay Satam, Stephen Robinson, Isabela Ribeiro, Marylore Chenel   +8 more
doaj   +3 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   +3 more sources

Use of In Vitro Dynamic Colon Model (DCM) to Inform a Physiologically Based Biopharmaceutic Model (PBBM) to Predict the In Vivo Performance of a Modified-Release Formulation of Theophylline

Pharmaceutics, 2023
A physiologically based biopharmaceutic model (PBBM) of a modified-release formulation of theophylline (Uniphyllin Continus® 200 mg tablet) was developed and implemented to predict the pharmacokinetic (PK) data of healthy male volunteers by integrating ...
Konstantinos Stamatopoulos, Connor O'Farrell, Mark J H Simmons   +2 more
exaly   +7 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   +3 more sources

PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report [PDF]

Molecular Pharmaceutics
The proceedings from the 30th August 2023 (Day 2) of the workshop "Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives" are provided herein. Day 2 covered PBBM case studies from six regulatory authorities which provided considerations for model verification, validation, and ...
Tycho Heimbach, Kimberly Raines, Luiza Borges   +2 more
exaly   +4 more sources

Emerging perspectives on leveraging physiologically based biopharmaceutics modeling (PBBM) for BCS class III biowaivers: A webinar summary [PDF]

Journal of Pharmaceutical Sciences
The regulatory framework for Biopharmaceutics Classification System (BCS) class III drug products provides a pathway for streamlined biowaivers in drug development, eliminating the need for expensive and time-consuming bioavailability and bioequivalence studies while maintaining quality standards.
Lanyan Fang, Sivacharan Kollipara, Tausif Ahmed   +2 more
exaly   +4 more sources

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

Molecular Pharmaceutics
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 ...
Evangelos Kotzagiorgis, Amitava Mitra, Kimberly Raines   +2 more
exaly   +5 more sources

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report [PDF]

Molecular Pharmaceutics
Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo.
Claire Mackie, Sumit Arora, Paul Seo
exaly   +4 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   +2 more sources