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 V 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
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 ...
Manuela Grimstein +2 more
exaly +4 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 ...
Sivacharan Kollipara +2 more
exaly +4 more sources
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report [PDF]
Molecular PharmaceuticsPhysiologically 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.
Xavier, Jh Pepin +2 more
exaly +4 more sources
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 +4 more
doaj +2 more sources
Surge Dose® Formulations of NSAIDs Provide for Ultra-Rapid and Consistent Drug Absorption in Both the Fasted and Fed State as Predicted by Physiologically Based Biopharmaceutics Modelling [PDF]
PharmaceuticsBackground/Objectives: This paper describes the use of physiologically based biopharmaceutics modelling (PBBM) to predict the effect of food on diclofenac and ibuprofen absorption from ultra-rapid-release Surge Dose® tablets.
Harri Dickinson +4 more
doaj +2 more sources