Safety pharmacology: Past, present, and future
The reasons for drug attrition have evolved over the years; over the last decade, lack of safety (both non-clinical and clinical) remains the major cause of attrition during clinical development, which accounts for approximately 35 to 40% of all drug discontinuation (see Table 13.1).1a-1c More worrying is the fact that there is no clear trend toward a reduction of the attrition owing to safety reasons. In this section, a brief summary of the nature, frequency, and consequences of adverse drug reactions (ADRs) in two clinical situations is presented. There are ADRs experienced by healthy volunteers and patients participating in clinical studies with potential new medicines and those experienced by patients who are prescribed licensed medicines.
