Bioequivalence and Bioavailability Forum • Biowaiver for intravenous drug / Anticancer molecule

kishorpatil
☆

2011-02-09 12:08
(5619 d 03:17 ago)

Posting: # 6601
Views: 4,608

Biowaiver for intravenous drug / Anticancer molecule [Design Issues]

Dear All,

As per different guidelines recommendation, that we can biowaive the parentals or intravenous injection. Can any body tell me that can we apply for the biowaiver of one of anticancer molecule by demonstrating the invitro release profile with that compare with innovator products. Is it possible to conduct the invitro bioequivalence of intravenous injection of anticancer molecule. I hope you will revert back to me.

Regards
pk

Edit: Category changed. [Helmut]

Jaime_R
★★

Barcelona,
2011-02-10 19:10
(5617 d 20:16 ago)

@ kishorpatil
Posting: # 6615
Views: 3,593

Biowaiver for intravenous formulation?!

Post reply

Hi Kishor!

I'm afraid I don't understand your question. :confused:

As you said, generally no study is required for iv formulations.
Next you talked about in vitro release - of a solution?!

If you have an immediate relase oral formulation, you might get a biowaiver if the drug belongs to BCS I (and maybe class III). See the respective guidelines for requirements.
The BCS-based biowaiver concept does not distinguish between therapeutic classes of drugs. Whether you have an anticancer drug or not is irrelevant. In some regulations NTIDs prohibt biowaivers.

—
Regards, Jaime