1. Physiologically Based Pharmacokinetic (PBPK) Modelling for In Vitro-In Vivo Extrapolation: Emphasis on the Use of Dissolution Data
- Author
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Pinal Chaudhari, Shaila A. Lewis, and Vivek M. Ghate
- Subjects
Physiologically based pharmacokinetic modelling ,education.field_of_study ,Gastric emptying ,Computer science ,In silico ,Population ,Pharmaceutical Science ,02 engineering and technology ,021001 nanoscience & nanotechnology ,030226 pharmacology & pharmacy ,03 medical and health sciences ,0302 clinical medicine ,Pharmacokinetics ,In vivo ,Pharmaceutics ,Dissolution testing ,Biochemical engineering ,0210 nano-technology ,education - Abstract
Recently the pharmaceutical sector has witnessed a drastic rise in the advancement and incorporation of computerbased technology into several unit operations. Drug dissolution profiling is an important consideration for the successful development of immediate and extended orally delivered formulations. Physiologically based pharmacokinetic (PBPK) modelling has gained a lot of attention when compared to the one- and two-compartmental modelling in establishing a relationship between the in vitro and in vivo parameters. Moreover, the influence of various factors like food, disease, population variations, transporters, and gastric emptying play a significant part in the in vivo outcome of the dosage form. In silico techniques are capable of addressing these limitations by incorporation of near-to-life replica of the in vivo conditions and are able to provide newer interpretations of conventional dissolution data that cannot be concluded by the generation of pharmacokinetic descriptors alone. This review focuses on the various in silico tools including the theory and studies conducted with dissolution data in recent years.
- Published
- 2019
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