NUR 162 CH. 11
- Phases in new drug testing (4)
Answer Phase I
Testing defines the range of dosages tolerated in healthy individuals.
Phase II
Effects of the drug are studied in a limited number of persons with the disorder. This phase defines the range of clinically effective dosages.
Phase III
Extensive clinical trials are conducted at multiple sites throughout the country with larger numbers of patients. Efforts focus on corroborating the efficacy identified in phase II. Phase III concludes with a new drug application being submit- ted to the FDA.
Phase IV
Drug studies continue after FDA approval to detect new or rare adverse reactions and potentially new indications. During this period, adverse reactions from the new medication should be reported to the FDA.
- target symptoms
Answer specific measurable symptoms expected to improve with treat- ment.
- side effects
Answer unwanted effects of medications
- adverse reactions
Answer 1 / 3
harmful, unintended, usually unpredicted reactions to a drug administered at the normal dosage that have serious physiologic consequences
- The U.S. Food and Drug Administration (FDA)
Answer responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radi- ation. The FDA approves the labeling of medications and other biologic treatments after a thorough review of efficacy and safety data
- prescribing information (PI)
Answer labeling content that includes approved indications for the medication, side effects, adverse reactions, contraindications, and other important information.
- Boxed Warning
Answer Drug warning that is placed in the prescribing information or package insert of the product and indicates a significant risk of potentially serious and dangerous side effects
- Drug molecules
Answer act at specific sites, not on the entire cell surface.
- Psychiatric medications
Answer primarily target the central nervous system (CNS) at the cellular, synaptic level at four sites
- synaptic level at four sites
- receptors
Answer
- ion channels
- enzymes 2 / 3
- carrier proteins.
- Pharmacodynamics
Answer the action or effect of drugs on living organisms.
- Receptors
Answer specific proteins intended to respond to a chemical (i.e., neurotrans- mitter) normally present in blood or tissues
- Agonists Drug
Answer Substances that initiate the same response as the chemical normally present in the body, (mimic the neurotransmitter) and have all three properties
Answer selectivity, affinity, and intrinsic activity.
- Antagonists Drug
Answer Substances that block the response of a given receptor and have only selectivity and affinity properties; they do not have intrinsic activity because they produce no biologic response by attaching to the receptor. (non-ad- dictive)
- partial agonists
Answer have some intrinsic activity (although weak).
- A drug's ability to interact with a given receptor type may be judged by three properties
- / 3
Answer selectivity, affinity, and intrinsic activity