In vitro–In Vivo Correlations: Tricks and Traps
Journal Title: The AAPS Journal - Year 2012, Vol 14, Issue 3
Abstract
In vitro–in vivo correlation (IVIVC) is a biopharmaceutical tool recommended to be used in development of formulation. When validated, it can speed up development of formulation, be used to fix dissolution limits and also as surrogate of in vivo study. However, as do all tools, it presents limitations and traps. The aim of the present paper is to investigate five common traps which could limit either the setting or use of IVIVC (1) using mean or individual values; (2) correction of absolute bioavailability; (3) correction of lag time and time scaling; (4) flip-flop model; and (5) predictability corrections.
Authors and Affiliations
J. -M. Cardot, B. M. Davit
Microdialysis as a tool in local pharmacodynamics
In many cases the clinical outcome of therapy needs to be determined by the drug concentration in the tissue compartment in which the pharmacological effect occurs rather than in the plasma. Microdialysis is an in vivo t...
Nonclinical Dose Formulation: Out of Specification Investigations
Nonclinical safety studies are required to follow applicable Good Laboratory Practice (GLP) regulations. Nonclinical dose formulations are required to be analyzed to confirm the analyte concentration, homogeneity, and st...
PEITC Induces G1 Cell Cycle Arrest on HT-29 Cells Through the Activation of p38 MAPK Signaling Pathway
Phenethyl isothiocyanate (PEITC), an isothiocyanate abundantly found in cruciferous vegetables have been shown to induce apoptosis through MAPK pathway in prostate and colon cancer cells. In the present study, we investi...
Mass Spectrometry Screening Reveals Peptides Modulated Differentially in the Medial Prefrontal Cortex of Rats with Disparate Initial Sensitivity to Cocaine
The online version of this article (doi:10.1208/s12248-010-9204-2) contains supplementary material, which is available to authorized users.
Comparison of Nonlinear Mixed Effects Models and Noncompartmental Approaches in Detecting Pharmacogenetic Covariates
The online version of this article (doi:10.1208/s12248-015-9726-8) contains supplementary material, which is available to authorized users.