MSimoes
☆    

Portugal,
2019-07-17 18:13

Posting: # 20383
Views: 1,037
 

 Statistical comparison of dissolution profiles - variable nr of units [Dissolution / BCS / IVIVC]

Dear BEBAC team,

What is your position on comparing dissolution profiles with different number of units? As far as I know, guidelines state one should use 12 units of each batch. However, sometimes and for QC reasons, we have 18 units of one batch and 12 units of another.

I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience?

Thanks in advance,
Marta

Regards,
MSimoes
ElMaestro
★★★

Belgium?,
2019-07-17 21:02

@ MSimoes
Posting: # 20384
Views: 860
 

 Statistical comparison of dissolution profiles - variable nr of units

Hi MSimoes,

» I don't think we should "choose" ou "not consider" some of the results, but then we are in a grey zone in the regulatory area. Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD? What is your experience?

That should generally be ok, in my experience.

Le tits now.

Best regards,
ElMaestro
MSimoes
☆    

Portugal,
2019-07-18 10:22

@ ElMaestro
Posting: # 20385
Views: 820
 

 Statistical comparison of dissolution profiles - variable nr of units

Dear ElMaestro,

Many thanks for your feedback!

Marta

Regards,
MSimoes
Helmut
★★★
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Vienna, Austria,
2019-07-18 13:06

@ MSimoes
Posting: # 20386
Views: 817
 

 EU: No Mahalanobis

Hi Marta,

» […] Is this comparison (18 vs 12 units, or other!) acceptable for f2, bootstrap f2 and MSD?

ƒ2 and bootstrap are fine. Mahalanobis is dead.

Cheers,
Helmut Schütz
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