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12 Cards in this Set

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Generics

What is the primary benefit of generic drugs?
Cost savings
Generics

What is the downside of generic drugs?
They have different bioequivalences
Generics

Does the FDA focus on animal/clinical data on safety and efficacy of generic drugs

-or-

Does the FDA focus on the therapeutic equivalence of drugs (as well as formulation, chemistry, stability, manufactoring process)?
FDA focuses on therapeutic equivalence (formulation, chemistry, manufactoring) of generic drugs
Generics

Four methods of determining therapeutic equivalence of generic drug?
1. in vivo pharmacodynamic comparison
2. in vivo limited clinical comparison
3. invitro comparison
4. in vivo measurement of active agent (most common way - this is therapeutic equivalence)
Generics

Definition of bioequivalence?
Pharmaceutical equivalents whose rate and extent of absorption are not statistically different when administered at the same dose under similar conditions (equivalent bioavailablity)
Generics

Definition of bioavailability?
Bioavailability: describe the rate and extent to which an active drug ingredient is absorbed from a drug product (and becomes available at the site of drug action)

Bioavailability is a means of predicting the clincial efficacy of a drug.
Generics

How would you substitute one drug with another of the same bioequivalence?
Bioequivalent products can be substituted for each other without any adjustment in dose or additional therapeutic monitoring.
Generics

Do you try and compare clinical effect when looking for differences in drugs?
No, it is difficult to quantify clinical effect.

The relationship is not linear; thus a small increase in dose can cause a significant change in HR (for example).
Generics

Instead of looking at clinical relationships to dose we look at pharmacokinetic relationships: Why? What is that relationship?
Pharmacokinetic measurement: using the blood to get a relationship between dose of the drug and the concentration of the drug in the body.

Why? We use this because is it a linear relationship.
Generics

What is the difference between bioequivalence and therapeutic equivalence?
The terms are used interchangeably. In his notes "Bioequivalence is the most common method of determining therapeutic equivalence for oral products; terms are often used interchangably"
Generics

Why are bioequivalence trials conducted?
They are conducted to ensure that two products do not differ in safety and efficacy.
Generics

How are bioequivalence trials conducted? (2)
1. get 20-40nl, healthy, adults
2. use a 2x2 crossover design with a single dose of the agent.
3. subjects are randomly selected for each group
4. washout period between the two drugs must be enough to allow the first drugs to be completely eliminated from the body.