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 +7 more
doaj +4 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 +4 more
doaj +3 more sources
Physiologically based biopharmaceutics modeling of regional and colon absorption in humans
European Journal of Pharmaceutics and Biopharmaceutics, 2023 Colon absorption is a key determinant for successful development of extended release and colon targeted drug products. This is the first systematic evaluation of the ability to predict in vivo regional differences in absorption and the extent of colon absorption in humans using mechanistic physiologically based biopharmaceutics modeling (PBBM).
Christer Tannergren +2 more
exaly +5 more sources
Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development—Industry Case Studies [PDF]
Journal of Pharmaceutical Sciences, 2016 In recent years, there has been a significant increase in use of physiologically based pharmacokinetic models in drug development and regulatory applications. Although most of the published examples have focused on aspects such as first-in-human (FIH) dose predictions or drug-drug interactions, several publications have highlighted the application of ...
Tycho Heimbach
exaly +4 more sources
Advances in Nasal Biopharmaceutics to Support Product Development and Therapeutic Needs [PDF]
PharmaceuticsBackground/Objectives: Nasal biopharmaceutics is the scientific understanding of product and patient factors that determine the rate and extent of drug exposure following nasal administration. The authors considered whether current biopharmaceutics tools
Ben Forbes +7 more
doaj +4 more sources
Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions. [PDF]
Mol PharmPharmaceutical innovators and generic companies use Physiologically Based Biopharmaceutics Models (PBBMs) to guide drug product development and potentially waive clinical pharmacokinetic studies for both pre- and postapproval changes. This modeling approach can assist with biopharmaceutics risk assessment and the establishment of patient centric ...
Arora S +23 more
europepmc +4 more sources
Integrating In Vitro Dissolution and Physiologically Based Pharmacokinetic Modeling for Generic Drug Development: Evaluation of Amorphous Solid Dispersion Formulations for Tacrolimus [PDF]
PharmaceuticsObjectives: Tacrolimus, a Biopharmaceutics Classification System (BCS) class II drug, is widely used for transplant patients to prevent graft rejection.
Evangelos Karakitsios +5 more
doaj +4 more sources
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report
Molecular PharmaceuticsThis Article shares the proceedings from the August 29th, 2023 (day 1) workshop "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". The focus of the day was on model parametrization; regulatory authorities from Canada, the USA, Sweden, Belgium, and Norway presented ...
Xavier Pepin +39 more
core +6 more sources
Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin–Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling [PDF]
PharmaceuticsBackground/Objectives: Fixed-dose combinations (FDCs) hold significant clinical value for the management of hypertension, diabetes and other chronic diseases.
Chenshuang Zhao +3 more
doaj +2 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 +2 more sources