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THE PHARMA REVIEW (JULY - AUGUST 2013)

Quantifying Benefit Risk Assessment

P.G.Yeole and Dhanalakshmi Iyer

Introduction: The benefits and risks of pharmaceutical products are constantly evaluated during drug development. An unfavourable benefit-risk balance in the development phase usually results in termination of research. Although marketing provides data in the form of spontaneous reports majorly, before marketing, clinical trials are the exclusive source of data on efficacy in humans but they also provide high-quality comparative data on the risks of the drugs being developed. Adverse reactions that are associated to the pharmacological action of a medicinal product are predictable, usually dose-dependent in a rather straightforward way, and likely to occur frequently (e.g., symptomatic hypotension during treatment of hypertension, hypoglycaemia in insulin-treated diabetic patients, or bradycardia with beta-blockers). Other adverse effects, such as allergic and idiosyncratic reactions, are neither predictable nor dose dependent and occur mostly in persons who may have a special sensitivity. 

 

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