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.