For knowing the acute adverse effects of a drug, the drug micro doses should be tested on:
Correct Answer: Two different species
Description: Ans. (a) Two different speciesType of TestApproachAcute toxicityDefined as dose that is lethal in approximately 50% of animals and is maximum tolerated dose.It requires usually two species, two routes, single dose.Subacute toxicityIt requires three doses and two species. 4 weeks to 3 months may be necessary prior to clinical trial.Chronic toxicityIt is done in Rodent and non-rodent species for 6 months or longer.Required when drug is intended to be used in humans for prolonged periods.Usually run concurrently with clinical trial.Carcinogenic potentialTwo years, two species.It is Required when drug is intended to be used in humans for prolonged periods.Mutagenic potentialEffects on genetic stability and mutations in bacteria (Ames test) or mammalian cells in cultureInvestigative toxicologyDetermine sequence and mechanisms of toxic action. Discover the genes, proteins, pathways involved. Develop new methods for assessing toxicity.
Category:
Pharmacology
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