Lec 8

Question 1

what is the goal of acute studies?

Answer 1

obtain data on dose-effect relationship
investigate acute toxicity
estimate safe acute doses
insight into target organs

Question 2

what are some initial considerations of acute studies?

Answer 2

chemical structure and properties
results of pre-existing tests
toxicity data one similar structured chemicals

Question 3

What is the typical animal model, dose selection and ingestion route for acute studies? what value is important to examine

Answer 3

1 rodent and non-rodent species

Dose selected based on drug’s physical properties and highest reasonable ingested dose.

ingestion through the intended route of drug and intravenous

important to obtain LD01 value (likely where therapeutic use changes into lethal)

Question 4

at what LD50 values is a drug: Extremely toxic, highly toxic, moderately toxic, slightly toxic, practically non-toxic and relatively harmless?

Answer 4

Extremely toxic - <5mg/kg
Highly toxic - 5-50mg/kg
Moderately toxic - 50-500mg/kg
Slightly toxic - 500-5,000mg/kg
Practically non-toxic - 5,000-15,000mg/kg
Relatively harmless - >15,000mg/kg

Question 5

What some pharmacokinetic considerations of acute studies?

Answer 5

toxicity depending on exposure route
plasma levels of drug vs. clinical signs occurrence
distribution to organs

Question 6

how long are animals typically exposure in sub-chronic studies? what types of animals are usually used

Answer 6

10% of their expected life
rodent group and a non-rodent group