qualityassurance
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2024-07-02 10:32
(225 d 15:11 ago)

Posting: # 24052
Views: 2,490
 

 Decrease in PSD: Need to repeat BE? [Study As­sess­ment]

Dear Forum members,

We have conducted a BE study with test product having PSD of X micron API. Now due to patent issue we want to decrease PSD of API to Y micron. Test product is BCS class 3 molecule.
Do we need to conduct BE study again due to change in PSD of API? Our target submission is EMA.

Regards,
QA
Helmut
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Vienna, Austria,
2024-07-02 11:37
(225 d 14:06 ago)

@ qualityassurance
Posting: # 24053
Views: 2,014
 

 Type-II Variation

Hi QA,

IMHO, this is Type-II Variation (according to the EMA’s Q&Aa change that may have a significant impact on the quality, safety or efficacy of the medicinal product’), and, thus, an in-vivo study is required. See also EC 2013/C 223/01, Section B.II.b.3.b).

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qualityassurance
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2024-07-02 13:29
(225 d 12:13 ago)

@ Helmut
Posting: # 24054
Views: 1,989
 

 Type-II Variation: Waive in-vivo study by providing in-vitro data?

Dear Helmut,

Thank you for the response.

Is it possible to waive in-vivo study if we achieve similar in-vitro dissolution profile in multimedia between test products (BE batch vs new formulation) having different particle size?

Regards,
QA
SMA
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Europe,
2024-07-02 18:27
(225 d 07:15 ago)

@ qualityassurance
Posting: # 24055
Views: 2,021
 

 Type-II Variation: Waive in-vivo study by providing in-vitro data?

Dear QA

❝ Is it possible to waive in-vivo study if we achieve similar in-vitro dissolution profile in multimedia between test products (BE batch vs new formulation) having different particle size?


BCS based biowaivers for class III products are possible according to the ICH M9 guideline which has already reached Step 5 in Europe (i.e. has been implemented).

However all of the conditions required for a Class III waiver have to be met and this goes beyond simply showing dissolution similarity.
Relaxation
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Germany,
2024-07-04 14:19
(223 d 11:23 ago)

@ SMA
Posting: # 24061
Views: 1,867
 

 Type-II Variation: Waive in-vivo study by providing in-vitro data?

Hello everybody

❝ However all of the conditions required for a Class III waiver have to be met and this goes beyond simply showing dissolution similarity.


And as I happen to have the ICH M-9 just in front of me for other reasons, I cite chapter 3 first paragraph:
"A drug product is eligible for a BCS-based biowaiver ... drug product is the same dosage form and strength"

Best regards!
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