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

posted by Helmut Homepage – Vienna, Austria, 2018-04-20 12:15 (957 d 11:27 ago) – Posting: # 18707
Views: 29,999

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.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,232 posts in 4,427 threads, 1,481 registered users;
online 7 (2 registered, 5 guests [including 3 identified bots]).
Forum time: Wednesday 22:43 CET (Europe/Vienna)

A big data-analyst is an expert
in producing misleading conclusions from huge datasets.
It is much more efficient to use a statistician,
who can do the same with small ones.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5