Drug Safety-Adverse Drug Reactions Flashcards
Define: Quantal dose-response curves.
Graph used to characterize pharmacological responses that are all-or-nothing (not graded) in a population of subjects
Looks at the minimum dose needed to produce a response
Does a quantal does-response curve have an Emax?
No, because it is graded.
What are the axes of the quantal dose-response curve?
Y-axis: Percent individuals responding
X-axis: Log of dose administered
Give some characteristics of a graded dose-response curves
Ever increasing doses given to an individual to determine max response (Emax)
Define and calculate: Therapeutic Index
Definition: compares midpoints. It is the factor by which you would have to increase the concentration of drug that elicits a response in 50% of the population to get to LD in 50% of population.
Ld50/ED50
Define and Calculate: Standard Safety Margin
Define: The percent by which you would have to increase ED99 to get LD1
[(LD1/ED99)-1] * 100
What two values create the limits of the therapeutic window?
ED99 and LD1
What are extension effects?
Arise from extension of therapeutic effect. They are dose-related and predictable
What are side effects?
Reactions that are unrelated to the therapeutic goal due to the binding of the same receptor at a different organ. They are predicable and dose-dependent
What are Idiosyncratic reactions?
Allergic Reactions?
Both can occur in the therapeutic range they are both unpredictable and dose-independent. Idiosyncratic reactions are genetically based.
Pregnancy Category: A
Well-controlled studies no show risk
Pregnancy Category: B
Animal study shows risk; well-controlled human study shows no risk OR No well-controlled studies
Pregnancy Category: C
Animal study shows risk; no well controlled human study
Pregnancy Category: D
Animal and human study show risk. Benefits vs. risks only in life-threatening or serious disease
Pregnancy Category: X
Contraindicated
