Since It is impossible for any medical it is impossible to render any medical intervention to be entirely risk-free. Therefore, the benefit and the risk must be evaluated in the use of all pharmaceutical products. Rather, when used appropriately, in accordance with approved prescribing information, the potential overall benefit of the drug outweighs the potential for harm. The benefit-risk balance of any medical intervention, including the use of pharmaceutical products, depends on the relationship between the intervention and the condition for which it is being used.
Different products require different degrees of safety.
During the latter half of the twentieth century, pharmaceutical development has become increasingly complex, largely as the result of improved understanding of disease mechanisms and individual biologic variability. Compared with the number of effective and safe treatments that were available less than fifty years ago, those that are taken for granted today represent a truly astonishing achievement. However, this increase in complexity has been accompanied by the development of a global regulatory environment in which new medicinal products are held to ever higher standards of efficacy, quality, and safety. The sections below present a brief description of each stage of safety monitoring. An important goal of these preclinical animal studies is to characterize any relationship between increasing doses of the drug and toxic effects which may be observed in the animals.