Bioequivalence and Bioavailability Forum • clinical trials/ BE studies for locally acting drugs

clinical trials/ BE studies for locally acting drugs [Regulatives / Guidelines]

posted by jagankm – 2012-01-25 12:26 (5264 d 12:07 ago) – Posting: # 7999
Views: 7,241

Dear Sir/ Madam,

Here we have a query regarding clinical studies of generic products for UK market (Bioequivalence studies). We are developing following generic drug products for UK market:

Docusate sodium 100mg soft gelatin capsules
Sulfasalazine Gastro-resistant Tablets 500 mg

Since both the above drugs are locally acting in gastro intestinal tract. As per the guidelines (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr *, CPMP/EWP/239/95 final), bioequivalence is not a suitable way to show therapeutic equivalence between two products. Could you give a suggestion in showing these two products bioequivalent to innovator products. And is it possible for biowaiver for both the above drug products or any other clinical studies to be conducted to show bioequivalent for these drug products.

Your kind help highly appreciated.

Complete thread:

clinical trials/ BE studies for locally acting drugsjagankm 2012-01-25 11:26
- clinical trials/ BE studies for locally acting drugs drgunasakaran1 2012-01-31 18:42
  - clinical trials/ BE studies for locally acting drugs Ohlbe 2012-01-31 19:01
    - clinical trials/ BE studies for locally acting drugs jagankm 2012-02-06 12:00
      - clinical trials/ BE studies for locally acting drugs Tina 2013-09-16 18:10
  - clinical trials/ BE studies for locally acting drugs Tina 2013-09-19 09:45