Guest Lecturer Flashcards
1
Q
Approval process for generic drugs
A
- Has to have same active ingredients (inactive doesn’t matter)
- Same strength, dosage form and route of administration
- Same use of indications
- bioequivalent
- Meet the same batch requirements (Identity, strength, purity, and quality)
- Manufactured under same FDA standards
2
Q
[Plasma] vs Time – draw and state Cmax, Tmax and AUC
A
IN NOTES
3
Q
Bioequivalence (How are 2 products equivalent?)
A
- Two products are equivalent if 90% of confidence interval of the AUC and Cmax is between 80-125%
4
Q
Confidence interval in Canada?
A
The relative mean Cmax is between 80-125 %
- no CI unless the therapeutic window is small or could cause death
5
Q
Results of omission and substitution of ingredients; (3)
A
- Different in vitro dissolution rates
- Rapid dissolving rates
- slow release properties (need this) can be absent
6
Q
What do we question when there is therapeutic failure with generics?
A
- Compliance
- Wrong drug/dose
- Drug-drug interaction
- Natural course of the disease
7
Q
What can Canada do to ensure generics are safe?
A
- use CI 90 for Cmax
- spot checks for physiochemical properties and fine delinquents
- Test for bioequivalence and indicate type of population
- inform patients of generic substitutions
