MSimoes
☆    

Portugal,
2020-09-16 16:01
(403 d 18:08 ago)

Posting: # 21922
Views: 917
 

 ICH M9 - reverse engineering? [Regulatives / Guidelines]

Dear BEBAC team,

Do you have experience with biowaivers and ICH M9 guideline?
When the M9 guidance mentions that we should have a formulation "qualitatively the same and quantitatively similar", especially for BCS class III drugs, how should be the quantitative formulation of the RLD justified? Is literature data enough, or do we need reverse engineering - and in this case, what is the level required (Q2 or Q3)? Only one method for each attribute or orthogonal analysis required?

This is not easy for some specific formulations, and the M9 is not clear in these requirements.

Thanks in advance for sharing your experience!

Kind regards,
Marta

Regards,
MSimoes
dshah
★    

India/ United Kingdom,
2020-09-17 06:46
(403 d 03:23 ago)

@ MSimoes
Posting: # 21923
Views: 735
 

 ICH M9 - reverse engineering?

Dear Marta,

» Do you have experience with biowaivers and ICH M9 guideline?

Many do have experience.

» When the M9 guidance mentions that we should have a formulation "qualitatively the same and quantitatively similar", especially for BCS class III drugs, how should be the quantitative formulation of the RLD justified? Is literature data enough, or do we need reverse engineering - and in this case, what is the level required (Q2 or Q3)? Only one method for each attribute or orthogonal analysis required?

When we are taking about biowaiver- mainly its for IR solid orals. and thus Q3 doesn't apply like for creams/gels/complex generic products.
Yes, indirectly reverse engineering is required and then CC/meeting with regulatory agency to confirm the similarity for Q1/Q2 could be one of the way.
Regards,
DShah
MSimoes
☆    

Portugal,
2020-09-17 15:56
(402 d 18:13 ago)

@ dshah
Posting: # 21924
Views: 707
 

 ICH M9 - reverse engineering?

Dear dshah,

Many thanks for your feedback. I suppose that orthogonal methods are also not required as we are not referring to complex formulations (IR only).

The CC/meeting is also crucial from the practical point of view.

Thanks, once again!
Marta

Regards,
MSimoes
dshah
★    

India/ United Kingdom,
2020-09-30 07:27
(390 d 02:42 ago)

@ MSimoes
Posting: # 21951
Views: 549
 

 ICH M9 - reverse engineering?

Dear Marta!

Pls find the recent presentation by FDA on - From General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness. It can be downloaded from - https://sbiaevents.com/files2/Innov-2020-Day-1.zip and see- D1S14-Kozak. It will be useful for BCS based biowaiver approach as well.

Regards,
Dshah
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