Integration of PKPD relationships into benefit-risk analysis.

ABSTRACT:

Aim

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.

Methods

A comprehensive literature search has been performed using MESH terms in PubMed, in which articles describing benefit-risk assessment and modelling and simulation were identified. In parallel, a critical review of multi-criteria decision analysis

SUBMITTER: Bellanti F 

PROVIDER: S-EPMC4631171 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature