Intro to Clinical Pharmacology Study Questions with 100% Correct Answers

Substances/chemical agents that affect biological systems. They do not create new physiological responses. They alter normal processes drugs The way the body affects the drug. Including absorption, distribution, metabolism, and excretion pharmacokinetics The action a drug has on a specific target of action in the body. Including mechanism of action, receptor interactions, close-response relationship, and therapeutic and toxic reaction pharacodynamics -regulates safety of food, drugs, cosmetics -requires drug labeling companies to including ingredient list -prohibits manufactures from making false & misleading claims fda 4 stages of approval for drugs preclinical investigations Clinical investigations Review of new drug applications Postmarketing surveillance Lab research performed on animals, human, microbial cells cultured in lab. Usually has 2 species. Must be complete and submitted to fda before next trail preclinical investigation Healthy subjects receive single dose of specific drug and are monitored Purpose is to determine proper and safe dose phase 1 trails Human subjects with specific disease for which drug is intended are given drug and monitored Approval for marketing may be effective & without serious side effects phase 2 trails Review of new drug application Takes 17-24 months for nda to be reviewed New drug must be proven "safe & effective" phase 3 trials Monitors actual use in larger population postmarketing surveillance