Individualized, discrete event, simulations provide insight into inter- and intra-subject variability of extended-release, drug products.

ABSTRACT:

Objective

Develop and validate particular, concrete, and abstract yet plausible in silico mechanistic explanations for large intra- and interindividual variability observed for eleven bioequivalence study participants. Do so in the face of considerable uncertainty about mechanisms.

Methods

We constructed an object-oriented, discrete event model called subject (we use small caps to distinguish computational objects from their biological counterparts). It maps abstractly to a dissolution test system and study subject to whom product was administered orally. A subject comprises four interconnected grid spaces and event mechanisms that map to different physiological features and processes. Drugs move within and between spaces. We followed an established, Iterative Refinement Pro

SUBMITTER: Kim SH 

PROVIDER: S-EPMC3563477 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature