C.4 Methodologies of Safety Assessment in Clinical Pharmacology

An important objective of clinical pharmacology is the early and ongoing assessment of the safety and tolerability of a new drug. This is done by assessing the type, frequency, and severity of side effects, assessing in which patient population these side effects may occur at which dose or exposure, for what duration and whether these side effects are reversible. The terminology for the safety assessment of drugs has some specifics that need to be explained right at the beginning of this chapter.