Drug Testing Flashcards
What does ADMET stand for?
Absorbed, Distributed, Metabolized, Eliminated, Toxic Effects
(description of standards for drug testing)
What are the time definitions for acute, subchronic, and chronic toxicity?
Acute - less than 24 hrs
Subchronic - weeks to months
Chronic - more than 3 months
What is the “no effect” dose?
Max dose at which toxic effects are not seen - used to set the Phase I dose
What are LD1 and LD50?
LD1 - minimum lethal dose
LD50 - median lethal dose
What is the difference between clinical trials and seeding trials?
Clinical - basis for obtaining FDA approval
Seeding - company sponsored trials on FDA approved drugs - not really any scientific purpose
Define placebo
Pill without medication
Define positive
Standard treatment medication
Define single-blind
Subject is unaware of identity of treatment
Define double-blind
Neither the subject nor the investigator know the identity of the treatment
What is the primary goal of Phase I and approximately how long does it last? Non-blind, single-blind, double blind?
The single dose that is administered is what fraction of the no effect dose?
Determine safety and dosage by identifying that dose at which signs of toxicity first appear - about 1 year - non-blind
1/10 - 1/100 of the no effect dose
What are the goals of Phase II and approximately how long does it last? Non-blind, single-blind, double blind?
Evaluate efficacy, determine dose range, look for side effects - about 2 years - single-blind
What is the goal of Phase III and approximately how long does it last? Non-blind, single-blind, double blind?
Verify efficacy of the drug and detect adverse reactions in a much larger subject pool - about 3 years - double-blind
What is the goal of Phase IV?
Post-approval monitoring - pharmacovigilance
