lecture 25 Flashcards
drug toxicity and drug development (6 cards)
Identify the three levels of risk-benefit analysis that occur related to drug therapy.
Accessibility: FDA evaluates benefits/risks for the population
Applicability: Provider evaluates benefits/risks for a patient
Acceptability: Patient evaluates benefits/risks in terms of personal values
State the three elements of information needed for application of an Investigational New Drug with the Food and Drug Administration.
Animal pharmacology and toxicology: Does it have the expected pharmacologic response? Some animal models are better than others (animals can’t tell us that they are anxious, but we can see pain response, etc.)
Manufacturing information: Will manufacturing be consistent and of exceptional quality?
Clinical protocol and investigator information: Who is running it and how will the clinical trial be managed/divided?
Differentiate between no observable adverse effect level and minimal anticipated biological effect level for determining the first dose in man for an investigational drug.
NOAEL is determined in appropriate animal species. HED is estimated and calculated using NOALE, divided by the safety factor to find MSRD.
Identify the primary reasons adverse drug events are often not detected until after the drug is approved and marketed for a period of time.
people respond to drugs differently
an error could have been made when estimating the dose
Provided key information about a potential pharmaceutical excipient (such as its presence on the GRAS list), determine whether or not preclinical toxicology studies are needed for its inclusion in a dosage form.
No, toxicology does not need to be studied because excipients on the GRAS list are already known
Name the five categories of preclinical studies typically completed in the development of a new drug.
Acute Studies: effect of a single dose, at least 2 species
Repeated Dose Studies: length depends on anticipated therapy, at least 2 species
Genetic Toxicity: determine likelihood that the compound is mutagenic or carcinogenic
Reproductive Toxicity: needs depends on target population, multiple species
Carcinogenicity: only for compounds used in chronic or recurring conditons
