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
Preparation of Alendronate Liposomes for Enhanced Stability and Bioactivity: In Vitro and In Vivo Characterization
Liposomes containing bisphosphonates have been shown to deplete circulating monocytes and reduce experimental restenosis. However, acceptable shelf life was not achieved, and the disruption extent and rate of the vesicle...
BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements
The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In...
Pharma Success in Product Development—Does Biotechnology Change the Paradigm in Product Development and Attrition
The biotechnology segment of the overall biopharma industry has existed for only about 40–45 years, as a driver of new product development. This driving force was initiated with the FDA approval of recomb...
Erratum to: Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?
Assessment of fertility in male rats after extended chemical castration with a GnRH antagonist
The purpose of this study was to assess whether male rats whose testosterone levels were suppressed to castration levels (<0.5 ng/mL) for a 1-year period by the sustained delivery of orntide acetate, a GnRH antag...