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6
Computer-aided biopharmaceutical
characterization: gastrointestinal
absorption simulation
Sandra Grbic, Jelena Parojcic, and Zorica Djuric,
Department of Pharmaceutical Technology and
Cosmetology, Faculty of Pharmacy, University of
Belgrade
Abstract:
This chapter introduces the concept of gastrointestinal
absorption simulation using
in silico
methodology. Parameters used
for model construction and the sensitivity predicted pharmacokinetic
responses to various input parameters are described. Virtual trials
for
in silico
modeling of drug absorption are presented. The infl uence
of food on drug absorption, as well as correlation between the
in vitro
and
in vivo
results, are also addressed, followed by biowaiver
considerations. Numerous examples are provided throughout the
chapter.
Key words:
Gastrointestinal absorption,
in silico
modeling,
parameter sensitivity analysis, virtual trials, food effects,
in vitro-in
vivo
correlation, biowaiver.
6.1 Introduction
Biopharmaceutical assessment of drugs is of crucial importance in
different phases of drug discovery and development. In early phases,
pharmaceutical profi ling can help to fi nd an appropriate 'drug-like'
molecule for preclinical and clinical development, and in later stages,
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