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NUR 162 ( LATEST 2024 / 2025 ) CH. 11 | WITH 100% VERIFIED ANSWERS
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NUR 162 ( LATEST 2024 / 2025 ) CH. 11 | WITH 100% VERIFIED ANSWERS
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NUR 162 CH. 111. 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.
2. target symptoms
Answer
specific measurable symptoms expected to improve with treat- ment.
3. side effects
Answer
unwanted effects of medications
4. adverse reactions
Answer
, harmful, unintended, usually unpredicted reactions to a drug administered at the normal dosage
that have serious physiologic consequences
5. 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
6. prescribing information (PI)
Answer
labeling content that includes approved indications for the medication, side effects, adverse
reactions, contraindications, and other important information.
7. 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
8. Drug molecules
Answer
act at specific sites, not on the entire cell surface.
9. Psychiatric medications
Answer
primarily target the central nervous system (CNS) at the cellular, synaptic level at four sites
10. synaptic level at four sites
Answer
1. receptors
2. ion channels
3. enzymes
, 4. carrier proteins.
11. Pharmacodynamics
Answer
the action or effect of drugs on living organisms.
12. Receptors
Answer
specific proteins intended to respond to a chemical (i.e., neurotrans- mitter) normally present in
blood or tissues
13. 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.
14. 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)
15. partial agonists
Answer
have some intrinsic activity (although weak).
16. A drug's ability to interact with a given receptor type may be judged by three properties
Answer
selectivity, affinity, and intrinsic activity
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