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 [PDF]
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 ...
Mark J.H. Simmons +2 more
exaly +11 more sources
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report [PDF]
Molecular PharmaceuticsThe 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 ...
Sumit Arora +2 more
exaly +5 more sources
Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report [PDF]
Molecular PharmaceuticsThis 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 ...
Sumit Arora +2 more
exaly +6 more sources
The Evolving Role of In Vitro–In Vivo Correlation in Model‐Informed Drug Development: A Multi‐Stakeholder Perspective [PDF]
CPT: Pharmacometrics & Systems PharmacologyIn 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 +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 PharmacologyThis 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 +8 more
doaj +3 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 +2 more
exaly +6 more sources
Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling [PDF]
CPT: Pharmacometrics & Systems PharmacologyOmaveloxolone 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 +5 more
doaj +3 more sources
Adult and pediatric physiologically‐based biopharmaceutics modeling to explain lamotrigine immediate release absorption process [PDF]
CPT: Pharmacometrics & Systems PharmacologyPhysiologically‐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 +10 more
doaj +3 more sources
In Silico Evaluation of the Biopharmaceutical and Pharmacokinetic Behavior of Metronidazole from Coated Colonic Release Matrix Tablets [PDF]
PharmaceuticsBackground: Physiologically based biopharmaceutics modeling (PBBM) models can help to predict drug release and in vivo absorption behaviors. Colon drug delivery systems have gained interest over the past few years due to the advantages they provide in ...
Roberto Arévalo-Pérez +2 more
doaj +4 more sources
A text mining study on the utility of physiologically based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) in formulation development [PDF]
Macedonian Pharmaceutical Bulletin, 2023 14th Central European Symposium on Pharmaceutical Technology, 28th - 30th September, Ohrid, N.
Krstevska, Aleksandra +3 more
openaire +3 more sources