Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds
Journal Title: The AAPS Journal - Year 2008, Vol 10, Issue 1
Abstract
The goal of this study was to apply gastrointestinal simulation technology and integration of physiological parameters to predict biopharmaceutical drug classification. GastroPlus® was used with experimentally determined physicochemical and pharmacokinetic drug properties to simulate the absorption of several weak acid and weak base BCS class II compounds. Simulation of oral drug absorption given physicochemical drug properties and physicochemical parameters will aid justification of biowaivers for selected BCS class II compounds.
Authors and Affiliations
Marija Tubic-Grozdanis, Michael B. Bolger, Peter Langguth
Keywords
Related Articles
- EP ID EP681542
- DOI 10.1208/s12248-008-9023-x
- Views 76
- Downloads 0
Permeability Comparison between Hepatocyte and Low Efflux MDCKII Cell Monolayer
Determination of passive permeability is not only important for predicting oral absorption and brain penetration, but also for accurately predicting hepatic clearance. High throughput (HT) measurement of passive permeabi...
Antidrug Antibody Assay Validation: Industry Survey Results
Immunogenicity of biopharmaceutical products has attracted considerable attention from the industrial, academia, and regulatory organizations. Many methods exist to detect and characterize level of antidrug antibody resp...
Use of Dried Blood Spots in Drug Development: Pharmacokinetic Considerations
Dried blood spots are increasingly being used in drug development. This commentary considers the pharmacokinetic issues that arise and compares these with those attached to plasma, the mainstay matrix. A common implicit...
The cytoplasmic escape and nuclear accumulation of endocytosed and microinjected HPMA copolymers and a basic kinetic study in hep G2 cells
The development of macromolecules as drugs and drug carriers requires knowledge of their fate in cells. To this end, we studied the internalization and subcellular fate of N-(2-hydroxypropyl)methacrylamide (HPMA) copolym...
Particle size analysis: AAPS workshop report, cosponsored by the Food and Drug Administration and the United States Pharmacopeia
The concepts of particle engineering and dosage form design have become dominant themes in pharmaceutical manufacturing. This trend is not simply a reflection of the development of new, more sophisticated manufacturing m...