NURS 615/NURS615 Chapter 2 – Review of Basic Principles of Pharmacology

How new drugs are developed - Preclinical stage- the early part of drug development. Identification of promising drugs and animal testing occurs during this stage. Testing on cells, organs, and tissues also occurs in the labs. - Toxicologists specialize in understanding the harmful effects of drugs and predicting as early as possible in the development process if a drug will harm patients. - Phase 1 clinical trials establish biological effects, as well as safe dosages and pharmacokinetics in a small number of healthy patients - Phase 2 clinical trials new drugs are used to treat disease in a small number of patients and establish potential of the drug to improve patient outcomes. - Phase 3 clinical trials will compare the new medication to standard therapy in a larger number of patients studied in populations across the nation - After being approved by the FDA, drugs are continually monitored through post market surveillance, in which health professionals report adverse events, which are studied by the pharmaceutical companies and the FDA - Pharmacogenomics = the study of how individual variations in drug targets or metabolism affect drug therapy. Performed in the post-marketing phase, it can identify biological factors responsible for predictable beneficial or adverse events in individual patients.