ABSTRACT
After completing this chapter, the reader should be able to:
outline briefly the process of evaluation and approval of new drugs;
define what is meant by a drug’s margin of safety;
outline briefly how unwanted drug effects arise, and differentiate between predictable and unpredictable reactions;
describe the underlying pathophysiology of drug allergy, and state examples of differing degrees of allergic severity;
describe the pharmacological properties that influence drug transfer across the placenta and into breast milk;
describe the factors that determine the teratogenic potential of drugs once they enter the embryonic/fetal circulation.