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pht 100 7

chapter 3 part 3

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
Created by: frescah



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