Population-Based Mechanistic Prediction of Oral Drug Absorption
Journal Title: The AAPS Journal - Year 2009, Vol 11, Issue 2
Abstract
The bioavailability of drugs from oral formulations is influenced by many physiological factors including gastrointestinal fluid composition, pH and dynamics, transit and motility, and metabolism and transport, each of which may vary with age, gender, race, food, and disease. Therefore, oral bioavailability, particularly of poorly soluble and/or poorly permeable compounds and those that are extensively metabolized, often exhibits a high degree of inter- and intra-individual variability. While several models and algorithms have been developed to predict bioavailability in an average person, efforts to accommodate intrinsic variability in the component processes are less common. An approach that incorporates such variability for human populations within a mechanistic framework is described together with examples of its application to drug and formulation development.
Authors and Affiliations
Masoud Jamei, David Turner, Jiansong Yang, Sibylle Neuhoff, Sebastian Polak, Amin Rostami-Hodjegan, Geoffrey Tucker
Keywords
Related Articles
- EP ID EP681475
- DOI 10.1208/s12248-009-9099-y
- Views 78
- Downloads 0
International Veterinary Bioequivalence Guideline Similarities and Differences Between Australia, Canada, Europe, Japan, New Zealand and the United States
Considering the diversity in physiology between species and the numerous dosage forms that exist in veterinary drug products, there are numerous complex issues that arise from the development and regulation of veterinary...
Cannabinoids, electrophysiology, and retrograde messengers: Challenges for the next 5 years
Most of the behavioral effects of cannabis and its active ingredients, the cannabinoids (Δ9THC being the most abundant of these), appear to be mediated by cannabinoid receptors. Endogenous cannabinoids (endocanna...
A Network Modeling Approach for the Spatial Distribution and Structure of Bone Mineral Content
This study aims to develop a spatial model of bone for quantitative assessments of bone mineral density and microarchitecture. A spatially structured network model for bone microarchitecture was systematically investigat...
Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items
Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be reference...
Issues related to targeted delivery of proteins and peptides
While modern genomic and proteomic technology enables rapid screening of novel proteins and peptides as potential drug candidates, design of delivery systems for these biologics remains challenging especially to achieve...