Powered by OpenAIRE graph
Found an issue? Give us feedback
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Biopharmaceutics & D...arrow_drop_down
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
Biopharmaceutics & Drug Disposition
Article . 2012 . Peer-reviewed
License: Wiley Online Library User Agreement
Data sources: Crossref
versions View all 2 versions
addClaim

Development strategies for IVIVC in an industrial environment

Authors: Jack A, Cook;

Development strategies for IVIVC in an industrial environment

Abstract

ABSTRACTProduct development is typically challenging. There is a strong desire to understand critical performance factors early in order to optimize formulations for Phase III trials or marketing approval. However, over 90% of drugs entering development in humans do not make it to the market. Thus there is a tremendous risk that resources spent early in development will be wasted as candidates attrite. To overcome this apparent dilemma, a Bayesian approach is suggested. In ‘traditional’ product development, clinical study designs are typically relatively assumption free and often do not consider learning from earlier investigations. A Bayesian approach is one in which prior information is considered when interpreting the results of the current study. A candidate IVIVC can be developed at the earliest stage of clinical development. Subsequently there are multiple opportunities within a typical development program to assess the performance of the preliminary IVIVC as new formulations are introduced. With each introduction, there is an opportunity to either confirm the adequacy of the IVIVC or to identify the need for development of a more predictive dissolution test and IVIVC. Copyright © 2012 John Wiley & Sons, Ltd.

Related Organizations
Keywords

Solubility, Therapeutic Equivalency, Predictive Value of Tests, Drug Design, Drug Evaluation, Preclinical, Humans, Bayes Theorem, Drugs, Investigational, Models, Biological

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    17
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Top 10%
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
17
Top 10%
Top 10%
Average
Upload OA version
Are you the author of this publication? Upload your Open Access version to Zenodo!
It’s fast and easy, just two clicks!