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It is useful to combine in vitro testing and in silico modelling to predict and understand the in vivo performance of formulations that improve bioavailability, resulting in a successful in vivo test for belinostat. The key factor for in vivo performance was determined to be dissolution in the stomach prior to transit in the proximal small intestine, as evidenced by in vitro data and in silico predictions.

Water activity (Aw) is a measure of the activity of free or unbound water that is available to participate in undesirable chemical, physical and biological reactions. Measurement of water activity at multiple time points during the product life cycle will be related to changes in critical quality attributes such as degradation of the active ingredient, changes in the rate of dissolution or disintegration and changes in physical properties such as hardness or friability. Controlling water...

The use of a polymer-based system reduces the risk of an undesirable chemical change in the drug product, or absorption of the drug product into the container, thereby reducing the dosage.

Rapid and adaptable evaluation of monoclonal antibody therapeutics using the Fc receptor panel test based on Octet System before selection of the final molecule. The Octet system optimises itself for each new mAb, optimising the buffer and background conditions, thus minimising any non-specific interactions that might occur. Once this is done, it is necessary to optimise the association and dissociation times of the receptors with that antibody. Accuracy and optimisation are the points...