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Bio & Generic PK
PK of Bioequivalence & Generics
| Question | Answer |
|---|---|
| Define NDA. | NDA = New drug application |
| How many years does it take for development associated with NDA? | 10-15 years! |
| Define ANDA. | ANDA = Abbreviated new drug application (aka generic) * Abbreviated bc inclusion of pre-clinical & clinical data is not required |
| How many years does it take for development associated with ANDA? | 1/2 - 2 years --> HUGE decrease! |
| What are the requirements that a generic product must prove? | A generic must be BIOEQUIVALENT to the existing brand/reference drug, by demonstrating the same ABSORPTION performance in vivo |
| Define 'bioavailability' | Bioavailability- RATE & EXTENT that the active ingredient (in pharmaceutical equivalents) becomes AVAILABLE at the SITE OF ACTION |
| How is bioavailability assessed? | Measurements intended to reflect the RATE & EXTENT drug becomes available at the site of action (ie. Cmax & Tmax) |
| When does a bioequivalence test (test vs reference drug product) need to be performed? (3-5) | - Commercial formulation vs Clinical Trial Material - Generic vs Reference/Brand drug - Drug product changed after approval (vs drug product before changed) --> aka new formulations - New indication for the same drug * BASICALLY, ANY CHANGE AT ALL!* |
| The 3 major PK parameters assessing bioequivalence are: | - AUC (EXTENT of absorption) - Cmax (RATE - & also extent - of absorption - Tmax (RATE of absorption) |
| Interchangability = ____________ + _________________ | Interchangability = PRESCRIB-ABILITY + SWITCH-ABILITY |
| A bioequivalent generic product must be _______________ with the original brand | INTERCHANGEABLE |
| Define PRESCRIBABILITY & SWITCHABILITY | * PRESCRIBABILITY- pt's treated for the FIRST TIME w either BRAND OR GENERIC (new patients) * SWITCHABILITY- a brand is SWITCHED to a bioequivalent GENERIC of the same drug (old patients |
| What 4 criteria must a product meet in order to be considered therapeutically equivalent (by the FDA)? | MUST have the SAME: -Active ingredient(s) -Dosage form -Route of admin -Strength |
| Name 7 reasons why biopharmaceuticals are different. | Too long to type - Pg 6 of Study Guide (2nd to last slide) |
| Biopharmaceuticals depend much more (than small molecules) on _____WHAT_____? | The MANUFACTURING process |
Created by:
myassen
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