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

posted by Helmut Homepage – Vienna, Austria, 2018-04-20 12:15 (1572 d 09:17 ago) – Posting: # 18707
Views: 32,054

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:
  1. high permeability, high solubility
      well absorbed, absorption rate higher than excretion
      BCS-based biowaiver generally possible
  2. high permeability, low solubility
      BA limited by solvation rate; IVIVC possible
  3. low permeability, high solubility
      BA limited by permeation rate
      BCS-biowaiver under certain conditions
  4. 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.

  1. 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, [image] free resource.
  2. 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, [image] free resource.

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