chapter 3 part 3
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
Help!
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| dna carries | genetic codes
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| rna is a component of genetic codes that | change amino acids into proteins
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| genetic engineering is the process of using | dna biotechnology for creating different drugs
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| biogenetic engineering created | insulins, antibloodclotting drugs, antiinflammatories, & viral/bacterial infection drugs
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| a therapeutic agent drug | prevents, cures, diagnoses, or relieves disease symptoms
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| baby aspirin helps those who are | at heartattack risk
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| pharmacodynamic agents are drugs that | alter bodily functions in ways desired
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| diagnostic agents are chemicals containing | radioactive isotopes use to diagnose illnesses
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| radio pharmaceuticals are | diagnostic agents
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| radio active isotopes are | unstable & produced radiative energy
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| radio pharmaceutical drugs (like nuclear medicine) uses isotopes to | visually examine organ function & biochemistry
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| prophylactic agents are | materials that prevent illnesses
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| prophylactic agents are | antiseptics, vaccines, antibiotics, etc.
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| destructive agents kill things like | bacteria, fungi, viruses, cells, etc.
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| antineoplastic drugs | fight cancer
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| pharmaceutical companies start with | long preclinical animal lab research
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| human studies on preclinical research can start when | the fda & the drug company's irb approves investigation on a new drug
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| nda means | new drug application
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| drug makers can apply for | a new nda after phase 3
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| human studies on preclinical research results are | evaluated by advisory panel
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| new drugs will be fda approved if | benifits outweigh risks
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| out of 5000-10000 compound developments, 250 will be | preclinically tested, 5 will go in human clinical trails, & will be approved
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| the fda may fast-track some | drugs for early approval
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| it takes about 10 yrs. & $1 billion to | develop a new drug
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| extended patents allow drug companies to | recoup those costs
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| a potential generic drug that is not patented goes through | a drug approval process
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| a potential generic drug that is not patented get produced when | the brand version goes off patent
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| a potential generic drug that is not patented must be proven to be | bioequivalent to the brand name drug
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| an nda is | new drug application
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| an nda is the process by which applicants must scientifically | demonstrate that the new drug is bioequivalent to the innovator drug in the presence of the fda
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| a bioequivalent drug contains | the same active ingredient & performs in the same way & timing that an innovator/brand name drug does
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| a drug with the same active ingredient & dosage meeting the same usp-nf compendial standards can be | substituted without contacting the prescriber
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| compendial standards are | strength, quality, purity, & identity
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| some pharmaceutical generic agents may have | different salts & come in different dosage forms
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| these pharmaceutical generics alternate drugs can't be | substituted without prescriber authorization
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Created by:
frescah
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