c
c 

„ Quality, efficacy, safety

„ Risk f(Frequency)
f(severity)
f(benefits)
Evaluated by,
Side effects Safety evaluations in clinical
studies
Post market surveillance Biochemical and genetic
studies
Literature evaluation Pharmacoepidemiology
^


 


„ Quality of life Ȃ physical, social, intellectual, emotional, economic

Prolonged life span

Declining diseases

„ Treatment benefit = Treatment effect Ȃ treatment failure Ȃ adverse

events

„ Risk= f(therapy)
ë

 


„ Risk/benefit ratio
Rofecoxib ( Vioxx ) Ȃ COX2 inhibitor, withdrawn
as a result of Cardiovascular adverse
reactions.
ADRǯs

Dosage related Pre- clinical trial

Patient related
 ë


 





„ For fixed combination

2*2 factorial design
½
 

½
 Placebo Comp. B


  Comp. A Comp.A, B


„ MCDA(multi criteria decision analysis)

  

„ Rosiglitazone (Avanindia)
Worsens conditions Ȃ weight gain, swelling,
bone fracture, heart diseases, risk of
cardiovascular deaths.
„ Antileukotrienes Ȃ Montelukast, zafirlukast
(benefits outweigh risks)
„ Perceptions of risk and quality of life to HRT
by Postmenopausal women
½
 
 





„ Epidemiological reference
¦ Natural history of disease studies of indicated
population
¦ History of treatment and healthcare
utilization
¦ Nature of anticipated drug-associated
diseases
¦ Epidemiological dataset for more detailed
analysis