Bioequivalence and Bioavailability Forum • BCS-based biowaivers for Class III

BCS-based biowaivers for Class III [Dissolution / BCS / IVIVC]

posted by Helmut – Vienna, Austria, 2018-04-20 14:15 (2190 d 22:28 ago) – Posting: # 18707
Views: 32,993

Hi Scopy,

maybe you are mixing something up. BCS of the drug and applicability of BCS-based biowaivers of the drug product. Classes¹ of the drug:

high permeability, high solubility
well absorbed, absorption rate higher than excretion
BCS-based biowaiver generally possible
high permeability, low solubility
BA limited by solvation rate; IVIVC possible
low permeability, high solubility
BA limited by permeation rate
BCS-biowaiver under certain conditions
low permeability, low solubility
low and highly variable BA

Whereas Class I drug products which are rapidly dissolving (≥85% dissolved in 30 minutes) may qualify for a biowaiver² Class III drug products have to be very rapidly dissolving (≥85% dissolved in 15 minutes).
For details see the FDA’s Biowaiver Guidance and Appendix III of the EMA’s BE Guideline.

Amidon GL, Lennernäs H, Shah VP, Crison JR. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability. Pharm Res. 1995; 12(3): 413–20. doi:10.1023/A:1016212804288, free resource.
Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, Shah VP, Lesko LJ, Chen ML, Lee VH, Hussain AS. Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions. Pharm Res. 2002; 19(7): 921-5. doi:10.1023/A:1016473601633, free resource.

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Complete thread:

BCS III Classification Obinoscopy 2018-04-20 08:09
- BCS-based biowaivers for Class IIIHelmut 2018-04-20 12:15
  - BCS-based biowaivers for Class III Obinoscopy 2018-04-20 16:06
  - BCS-based biowaivers for Class III The Outlaw Torn 2018-06-21 09:48
    - BCS-based biowaivers for Class III nobody 2018-06-21 10:33
      - BCS-based biowaivers for Class III The Outlaw Torn 2018-06-21 12:11
      - BCS-based biowaivers for Class III: Syrups Helmut 2018-06-21 12:21
        
        BCS-based biowaivers for Class III: Syrups The Outlaw Torn 2018-06-21 12:47
        
        BE of solutions Helmut 2018-06-21 13:33
        
        BE of solutions The Outlaw Torn 2018-06-21 13:39
        BE of solutions The Outlaw Torn 2018-06-27 15:22
        
        Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study Obinoscopy 2018-07-01 02:06
        
        Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study The Outlaw Torn 2018-07-03 15:02
        
        Reversed procedure? Helmut 2018-07-03 15:33
        
        Reversed procedure? The Outlaw Torn 2018-07-04 11:50
        
        BioBridges Helmut 2018-07-04 12:03