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What are the disadvantages of Concentration time plots?
- Limited utility
- Do not describe the actual drug movement
What are the methods for determining Area Under the Curve?
- Calculus integration
- Cut and way paper
- Trapezoid method
What is the equation for the area of a trapezoid?
1/2(base1 + base2) x height
How do you use the trapezoid method for determining the area under the curve?
Approximate the linear function and then use teh equation:
1/2(base1 + base2) x height
What are the units for an AUC of a concentration time curve?
What does the area under the curve for a concentration time plot mean?
The total drug exposure
What is the Area under the curve affected by?
All drug processes and movements
What can the AUC be used for?
Comparing drug products and dosage forms
How is Bioavailability usually reported?
As a percentage of the total drug given
Is Bioavailability a measure of drug action and effects?
- Is somewhat interpreted that way, assumed to be related
- Though, is not really
What is the Equation for Bioavailability?
F = AUCa/AUCb
What is the critical determining factor for Bioavailability?
What is the denominator of Bioavailability?
The Reference material
What is Relative Bioavailability?
A comparison between two dosage forms, where one form becomes the denominator
What is the absolute Bioavailability?
A comparison of the amount of drug that reaches circulation to the amount that was given
What is the reference/denominator for Absolute Bioavailability?
The AUC following IV administration
What are the assumptions of Bioavailability?
- Patient sample is representative
- Absorption is the universal and unchanging
What is Pharmaceutical Equivalence?
- Contains the same active ingredient(s)
- Same dosage form/Route of administration
- Identical in strength or concentration
- May differ in shape, scoring configuration, release mechanisms, packaging, excipients, expiration time
What is Pharmaceutical Alternatives?
- Contain the same therapeutic moiety
- Different salts, esters, or complexes of that moiety, or are different dosage forms or strengths
- Different dosage forms and strengths and extended-release products within a product line by a single manufacturer are pharmaceutical alternatives
What is Therapeutic Equivalent?
- They are pharmaceutical equivalents and can be expected to have the same clinical effect and safety profile
Who conducts Bioequivalence studies?
Generic drug manufacturers
What are FDA pivotal parameters for Bioequivalence?
- tmax (subjective)
- All should be 80-120% of the reference product
What are the limits on AUC, Cmax and tmax of a generic drug compared to a reference drug?
- Need to be within 80-120% of the reference drug
What are bioavailability studies used for usually?
To compare different routes of administration
What are Bioequivalence studies used for usually?
Compare new drugs to a known drug product
What are the units for Salt factor?
What are the units of Bioavailability?
What is the salt factor?
The fraction of the dose that is bioavailable and is active
What is the Amount available of a drug?
The dose times the bioavailability times the percent that is in an active form (the salt factor)
How do you calculate Bioequivalence?
SxFxD = SxFxD
What drugs are concerning to give bioequivalents of?
- Drugs that:
- have a small therapeutic range
- require high doses
- are not well absorbed
- studies show different products have different effects
What is Bioavailability?
The rate and extent to which the AI is absorbed and available at the site of action
What is a Bioequivalent drug product?
- Pharmaceutical equivalent or alternative products with comparable bioavailability
- May sometimes be demonstrated using an in vitro bioequivalence standard, especially when such an in vitro test has been correlated with human in vivo bioavailability data.
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