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Bio & Generic PK

PK of Bioequivalence & Generics

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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