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Abstract
Despite the continuous endeavour to achieve high standards in medical care through
effectiveness measures, a quantitative framework for the assessment of the benefit-risk
balance of new medicines is lacking prior to regulatory approval. The aim of this
short review is to summarise the approaches currently available for benefit-risk assessment.
In addition, we propose the use of pharmacokinetic-pharmacodynamic (PKPD) modelling
as the pharmacological basis for evidence synthesis and evaluation of novel therapeutic
agents.