Physiologically-based pharmacokinetic formulation

A recent shift in emphasis has been from simple DMPK parameters to a more physiological interrogation of the data. Such physiological based pharmacokinetic modelling may provide mechanistic links to understand the influence of drug delivery formulations, or even the relationship between efficacy and toxicity at the tissue level. However literature examples of the benefit of such detailed analysis are sparse, or even lacking. 

Pharmaceutical companies, hospital and community pharmacies prepare medicines. Although batch sizes vary greatly, the underlying principles of product development are comparable and driven by physical chemistry, physiology and pharmacokinetics. When the medication is meant for only a small group of patients or even for individual use, these principles cannot be fully elaborated and formulation becomes more and more based on risk assessment. 

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