Back to the Top
Recent times I am seeing posts on IVIVC referring extrapolation of
drug-drug interactions into clinical relevance I want to add a
clarification in this regard. IVIVC is understood by broad section
of Pharmaceutical Community as a relationship between the
Bioavailability and drug product in vitro dissolution properties
(ref: FDA guidance and USP definition and even in CFR), to avoid
confusion recently drug metabolism focus group of the AAPS coined the
word " In vitro-In vivo Extrapolation" IVIVE to describe the
relationship between drug metabolism absorption, resultant drug
interactions observed in the laboratory models and their clinical
relevance in Human or real life situations. I hope this
clarification helps in properly referencing this topic under discussion.
Prasad
Prasad NV Tata, Ph.D., FCP
Manager-Pharmacokinetics
Mallinckrodt, Inc.
675 McDonnell Blvd.
Saint Louis, MO 63134
e-mail: prasad.tata.-at-.covidien.com
Back to the Top
The following message was posted to: PharmPK
Prasad,
Thanks for point this out:
> drug metabolism focus group of the AAPS coined the
> word " In vitro-In vivo Extrapolation" IVIVE to describe the
> relationship between drug metabolism absorption, resultant drug
> interactions observed in the laboratory models and their clinical
> relevance in Human or real life situations.
If the AAPS group had been more agile it might have proposed
something based on a contemporary language rather than Latin e.g.
AGILE = Any Glass-In Life Extrapolation
Nick
--
Nick Holford, Dept Pharmacology & Clinical Pharmacology
University of Auckland, 85 Park Rd, Private Bag 92019, Auckland, New
Zealand
n.holford.at.auckland.ac.nz
www.health.auckland.ac.nz/pharmacology/staff/nholford
|
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Clarification on IVIVC" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)