DRUG TOXICITY & DRUG DEVELOPMENT

Question 1

Identify the three levels of risk-benefit analysis that occur related to drug therapy

Answer 1

Accessibility
Applicability
Acceptability

Question 2

Describe Accessibility as level of risk-benefit analysis that occur related to drug therapy

Answer 2

Decided by organizations like the FDA
Should this drug be accessible for patient use?
(Evaluates benefits / risks for the population)

Question 3

Describe Applicability as level of risk-benefit analysis that occur related to drug therapy

Answer 3

Decided by Provider
Is this drug appropriate for the patient to use?
(Evaluates benefits / risks for a patient)

Question 4

Describe Acceptability as level of risk-benefit analysis that occur related to drug therapy

Answer 4

Decided by Patient
Is taking this drug acceptable?
(Evaluates benefits / risks in terms of personal values)

Question 5

List the three elements of information needed for application of an Investigational New Drug with the Food and Drug Administration

Answer 5

Animal pharmacology & toxicology
Manufacturing information
Clinical protocol & investigator information

Question 6

How do you predict the first dose in man for a new drug?

Answer 6

Step 1 – Determine the maximal No Observable Adverse Effect Level (NOAEL) in appropriate animal species
Step 2 – Calculate human equivalent dose (HED) from appropriate species
Step 3 – Determine a safety factor (usually 10)
Step 4 – Divide HED by safety factor to determine the MRSD (max recommended starting dose)

Question 7

Identify the primary reasons adverse drug events are often not detected until after the drug is approved and marketed for a period of time

Answer 7

Rare events versus patient numbers in clinical trials
Common events versus patient numbers and duration in clinical trials

Question 8

Name the five categories of preclinical studies typically completed in the development of a new drug

Answer 8

Acute studies
Repeated dose series
Genetic toxicity
Reproductive Toxicity
Carcinogenicity

Question 9

Describe “acute studies” as a category of preclinical study

Answer 9

Determines the effect of single dose
Tested on at least 2 species

Question 10

Describe “repeated does series” as a category of preclinical study

Answer 10

Length of series depends on anticipated therapy
Tested on at least 2 species

Question 11

Describe “genetic toxicity” as a category of preclinical study

Answer 11

Determines the likelihood that the compound is mutagenic or carcinogenic

Question 12

Describe “reproductive toxicity” as a category of preclinical study

Answer 12

Need for this testing depends on target population
Tested on multiple species

Question 13

Describe “carcinogenicity” as a category of preclinical study

Answer 13

Only needed for compounds used in chronic or recurring conditions