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