test 3 Flashcards
Bioavailability
Rate and extent to which the active ingredient is absorbed from drug product and becomes available at the site of action
What is bioavailability influenced by?
Method of manufacture
Particle size
Crystal form
Properties of excipients
Physical changes as drug products age
What do BA studies used to compare?
Different dosage forms via different routes (which one has the most desirable absorption pattern)
What are BA studies used to estimate?
Administration dose that gets into circulation
The effect of food on the drug
Distribution and elimination characteristics
Performance of the formulation
Bioequivalence
Absence of bioavailability difference between the test drug and reference drug
What is plasma concentration used for in be testing?
It is considered a surrogate for the concentration of the drug at the site of action
What are BE studies used for?
To compare the BAs of different formulations, drug products or batches of the same drug
How do you find the relative bioavailability?
Dose of ref product x AUC of test drug after oral admin/ Dose of test drug x AUC of reference drug after oral dose
What is relative bioavailability used to see?
Drug drug interactions
Food effects
How new formulations impact bioavailability
What are cross over design studies used for?
For determination of therapeutic equivalence between generic and reference drug
What does AUC represent?
The total amount of drug absorbed into circulation
Compare total exposure or extent of drug absorption
How do you find absolute bioavailability?
IV dose x AUC after oral dose/
Oral dose x AUC after IV dose
What are therapeutic equivalents?
Drug products that are pharmaceutical equivalents with the same clinical effect and safety profile for which bioequivalence has been demonstrated
What are pharmaceutical equivalents?
Drug products that have identical dose of identical API with the same esters or salt forms and identical dosage forms
What are pharamaceutical alternatives?
Identical API or precursor that do not have the same amount, dosage forms, or salt or ester
What is class one of BCS classes?
High solubility and high permeability
What is class 2 of BCS?
Low solubility and high permeability
What is class 3 of BCS?
High solubility and low permeability
What is class 4 of BCS?
Low solubility and low permeability?
What classes do not require BABE studies?
Class 1 and 3 (high permeability)
What is the Orange Book?
A book of approved drug products with therapeutic equivalence evaluations
According to the Arrhenius equation, what happens when temperature increases?
The rate of the reaction does as well
What is shelf life?
Time interval that a drug product is expected to remain within the approved shelf life under specific conditions (90% of the drug left)
What is shelf life used for?
Used to determine expiration date of drug products
