BCS-based Biowaivers
Our attention to BCS-based biowaivers is an imprint of the fact that they represent intelligent, ethical, time and cost-saving concept for product launch.
We know how to put the pieces together:
- use maximum amount of existing evidence of permeability/absorption/bioavailability
- advise on what additional data needs to be generated for your substance to be classified BCS 1/3
- write convincing and strong justification
Reflecting our experience we highly recommend prospective development approach to avoid issues with excipients, unsimilar dissolution profiles, costly and time-consuming analytical testing.
| Drugs where BCS-based biowaiver is clearly supported by EMA (Product-Specific Guideline) |
| Agomelatin |
BCS 1 |
| Aliskiren |
BCS 3 |
| Apixaban |
Data to be generated |
| Emtricitabine |
BCS 1 |
| Entecavir |
Data to be generated |
| Imatinib |
(possible BCS 1) |
| Lenalinomide |
(possible BCS 1) |
| Memantine |
BCS 1 |
| Miglustat |
Data to be generated |
| Oseltamivir |
(possible BCS 3) |
| Paracetamol |
BCS 1 |
| Sitagliptin |
BCS 1 |
| Sunitinib |
BCS 1 |
| Telithromycin |
Data to be generated |
| Tenofovir |
Data to be generated |
| Tenofovir disoproxil |
BCS 1 |
