Finals Flashcards
Induction of developmental defects in the somatic tissues of the fetus
Teratogens is
During what time of pregnancy does teratogens is is being tested
Organogenesis
Fetuses and neonate a
Induction of changes in the genetic material of animals of any age and therefore induction of heritable abnormalities
Mutagenesis
Standard in vitro test for mutagenesis that uses special strain of Salmonella
Ames test
Exposure of the fetus to a radiation, infection or chemical. Teratogens is or mutagenesis?
Teratogens is
In Vigo mutagenecity test carried out in mice
Dominant lethal test
The maximum dose at which a specified toxic effect is not seen
No-effect dose
Smallest dose that is observed to kill any experimental animal
Minimum lethal dose
The dose that kills approximately 50%of the animal
Median lethal dose (LD 50)
Either studies in animals have revealed adverse effect son the fetus and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only when potential benefits justifies the potential risk
Category C
There is positive evidence of human fetal risk, but the benefit from use in pregnant women may be acceptable despite risk
Category D
Alternating periods of administration of test drug, placebo preparation and the standard treatment
Crossover design
What phase of clinical trial uses small number of healthy volunteers to find the maximum tolerated dose
Phase 1
Phase that is performed in research centers by specially trained clinical pharmacologist
Phase 1
Patients are 100-200 and determine efficacy of drug which is done in special clinical centers
Phase 2
Utilizes single blind design and has the highest rate of drug failures
Phase 2
Therapeutic confirmatory trials, designed to minimize errors by randomness controlled trials, usually expensive
Phase 3
Immunologic processes may become apparent at this stage
Phase 3
Drug for rare disease
Orphan drugs
Leading candidate for a successful new drug and can proceed to patent application
Lead compound
Measurement of the percentage of receptors bound by a drug in relation to dose
Graded dose binding relationship and binding affinity
Concentration of drug required to bing 50% of the receptor sites
I’d
Maximum amount of drug or radioligand which can bind specifically to the receptors in a membrane preparation
Bmax
True or false: smaller the Kd, greater the affinity of drug to its receptor
True