Biorelevant media are commonly used to simulate the physiological composition of human
intestinal fluids (HIF) in in vitro solubility and dissolution investigations. In comparison with …

A comprehensive search in literature and published US Food and Drug Administration
reviews was conducted to assess whether physiologically based pharmacokinetic (PBPK) …

The effect of food on pharmacokinetic properties of drugs is a commonly observed
occurrence affecting about 40% of orally administered drugs. Within the pharmaceutical …

Aims When administered orally as either an immediate or modified release dosage form,
zolpidem demonstrates a negative food effect, ie decrease in C max and AUC. The aim of …

In recent years, the gut microbiome has gained increasing appreciation as a determinant of
the health status of the human host. Bile salts that are secreted into the intestine may be …

The biopharmaceutics risk assessment roadmap (BioRAM) optimizes drug product
development and performance by using therapy‐driven target drug delivery profiles as a …

Whilst the reproducibility of models in the area of systems biology and quantitative systems
pharmacology has been the focus of attention lately, the concept of 'reusability'is not …

The EU research initiative OrBiTo (oral biopharmaceutics tools) involving partners from
academia, pharmaceutical industry, small medium enterprises and a regulatory agency was …

Supercritical fluid technology (SFT) is an insufficiently investigated approach for the
production of solid dispersions, it is environmentally acceptable and has a high potential for …

The purpose of this study was to evaluate the usefulness of the in vitro biorelevant
gastrointestinal transfer (BioGIT) system in assessing the impact of dose and formulation on …