TY - JOUR
T1 - State of the art in benefit-risk analysis: medicines
AU - Luteijn, J.
AU - White, B.
AU - Gunnlaugsdottir, H.
AU - Holm, F.
AU - Kalogeras, N.
AU - Leino, O.
AU - Magnusson, S.
AU - Odekerken-Schröder, G.J.
AU - Pohjola, M.
AU - Tijhuis, M.J.
AU - Tuomisto, J.
AU - Ueland, O.
AU - McCarron, P.A.
AU - Verhagen, H.
PY - 2012/1/1
Y1 - 2012/1/1
N2 - Benefit–risk assessment in medicine has been a valuable tool in the regulation of medicines since the 1960s. Benefit–risk assessment takes place in multiple stages during a medicine’s life-cycle and can be conducted in a variety of ways, using methods ranging from qualitative to quantitative. Each benefit–risk assessment method is subject to its own specific strengths and limitations. Despite its widespread and long-time use, benefit–risk assessment in medicine is subject to debate and suffers from a number of limitations and is currently still under development.this state of the art review paper will discuss the various aspects and approaches to benefit–risk assessment in medicine in a chronological pathway. The review will discuss all types of benefit–risk assessment a medicinal product will undergo during its lifecycle, from phase i clinical trials to post-marketing surveillance and health technology assessment for inclusion in public formularies. The benefit–risk profile of a drug is dynamic and differs for different indications and patient groups. In the end of this review we conclude benefit–risk analysis in medicine is a developed practice that is subject to continuous improvement and modernisation. Improvement not only in methodology, but also in cooperation between organizations can improve benefit–risk assessment.
AB - Benefit–risk assessment in medicine has been a valuable tool in the regulation of medicines since the 1960s. Benefit–risk assessment takes place in multiple stages during a medicine’s life-cycle and can be conducted in a variety of ways, using methods ranging from qualitative to quantitative. Each benefit–risk assessment method is subject to its own specific strengths and limitations. Despite its widespread and long-time use, benefit–risk assessment in medicine is subject to debate and suffers from a number of limitations and is currently still under development.this state of the art review paper will discuss the various aspects and approaches to benefit–risk assessment in medicine in a chronological pathway. The review will discuss all types of benefit–risk assessment a medicinal product will undergo during its lifecycle, from phase i clinical trials to post-marketing surveillance and health technology assessment for inclusion in public formularies. The benefit–risk profile of a drug is dynamic and differs for different indications and patient groups. In the end of this review we conclude benefit–risk analysis in medicine is a developed practice that is subject to continuous improvement and modernisation. Improvement not only in methodology, but also in cooperation between organizations can improve benefit–risk assessment.
U2 - 10.1016/j.fct.2011.06.008
DO - 10.1016/j.fct.2011.06.008
M3 - Article
SN - 0278-6915
VL - 50
SP - 26
EP - 32
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
IS - 1
ER -