VijithRoy
☆    

India,
2020-07-30 13:15
(4 d 22:22 ago)

Posting: # 21807
Views: 219
 

 Difference between BABE study and clinical trials [Design Issues]

Dear all,

Clinical trial is the process of new drug development and where as BABE is for already marketed drug (Generic drug).

Does BABE study will consider under Clinical Trial studies ?

Do all the generic drugs undergo BABE study for getting approval ?


Thank you in advance.
Obinoscopy
★    

USA,
2020-07-30 14:31
(4 d 21:06 ago)

(edited by Obinoscopy on 2020-07-30 14:49)
@ VijithRoy
Posting: # 21808
Views: 202
 

 Difference between BABE study and clinical trials

Ok I think I can try answering this one.

Dear Roy,

» Clinical trial is the process of new drug development and where as BABE is for already marketed drug (Generic drug).

Well...basically true. A Phase III Clinical Trial is the gold standard for new molecules. For molecules that are already in the market and another company wishes to register it as a generic, he or she mostly resort to BABE Studies.

However there are some additional notes that I must add:

Clinical Trials can also be done for generics but that's not the most appropriate study. So the applicant will have to provide justification why they couldn't do a BABE study instead.

» Does BABE study will consider under Clinical Trial studies ?

Well I will say yes and no. Phase I Clinical Trial has some similar components to BABE Studies. That is the pharmacokinetic (Bioavailability) component. Also some applicants include a full BABE study in their list of Clinical Trial Experiments if they made some major modifications on the batch they used for the Phase III Clinical Trial. But technically I'll say no, BABE Studies is not always done under Clinical Trials intended for a new drug application.

» Do all the generic drugs undergo BABE study for getting approval ?

Not all. But most.

» Thank you in advance.

You are welcome. I'm not 100% certain of my responses though. Hopefully the experts will come in and give a more appropriate response.

Regards

Scopy
Helmut
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Vienna, Austria,
2020-07-30 14:35
(4 d 21:03 ago)

@ VijithRoy
Posting: # 21809
Views: 201
 

 BABE ∈ Phase I

Hi VijithRoy,

» Clinical trial is the process of new drug development and where as BABE is for already marketed drug (Generic drug).

Not quite. For a generic you aim to demonstrate BE. Only if the applicant succeeds, it will be approved and can be marketed. BE is also required for originators when scaling up from the batches (likely less than 10,000 units) used in their Phase III trials to the final production batch size (sometimes millions of units) and for any drug if the formulation is substantially modified (for minor changes in vitro similarity is sufficient).

<picky>

There are no “BE studies”. Bioequivalence is the desired outcome of a comparative bioavailability study. Only Health Canada got it in its guidelines right. ;-)

</picky>

» Does BABE study will consider under Clinical Trial studies ?

Yes. Phase I (human pharmacology). Mostly healthy volunteers, sometimes patients.
Rarely I saw “Phase I/IV” mentioned in protocols/reports. The idea behind was that the generic is in Phase I and the originator in Phase IV (post-marketing). That’s not correct since in Phase IV solely patients are studied (and rarely under controlled conditions).

» Do all the generic drugs undergo BABE study for getting approval ?

No. If in BCS class I (or under certain conditions in class III) a BCS-based biowaiver is possible.

PS: Consider this post as a refresher.

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dshah
☆    

India,
2020-07-31 08:46
(4 d 02:52 ago)

@ VijithRoy
Posting: # 21813
Views: 141
 

 Difference between BABE study and clinical trials

Dear VijithRoy!
As rightly mentioned by Helmut, BABE studies are considered as Phase-I study. Generally the concept for generics to perform BABE study is to use the already available knowledge of Innovator for safety and efficacy.
Apart from BCS based biowaiver;
A- Parenteral (IV, IM, SC, IT) adm. as aqueous solution;
B- Solution for oral use,
C-Gas ,
D- Powder for reconstitution as a solution (Meeting above A or B)
E- Otic or ophthalmic or topical product prepared as an aqueous solution
and few other dosage forms can be considered for biowaiver where BE is self evident.
On the other hand, Q1/Q2/Q3 criteria may needs to be matched to Innovator (case to case basis).

Regards,
DShah
VijithRoy
☆    

India,
2020-07-31 11:52
(3 d 23:46 ago)

@ dshah
Posting: # 21814
Views: 122
 

 Difference between BABE study and clinical trials

Thank you so much for your clear information sir. @ Helmut @ Dshah.

Hope this will really help me to look out further.


Best Regards,
T. Vijith.
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