Gopal
☆    

India,
2015-01-07 17:31
(3368 d 13:40 ago)

Posting: # 14239
Views: 4,185
 

 Clarification regarding CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** [Regulatives / Guidelines]

Hi all,

Greetings!

I would like to request clarification regarding BE guidelines CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **. Request you to please advice if the general Biowaiver criteria, should be applied to the additional strengths that require waiving only or should the higher/lower strength on which BE needs to be performed also need to comply with the biowaiver criteria?

For eg., and to be more specific, the condition "C" states that the composition of the other strengths should be quantitatively proportional. Deviation of the same provides other conditions of which the condition 1 (mandatory condition) that the amount of active substance is less than 5% of the core weight/fill weight.

Please advice if this condition applies to the strength on which BE will be performed or should this be applied to only additional strengths that need to be waived?

And if the BE strength does not comply with this condition and contains active substance more than 5%, can we still proceed with applying the biowaiver criteria??

Thank you so much in advance for your kind advice!

Regards,
Gopal
Dr_Dan
★★  

Germany,
2015-01-07 17:54
(3368 d 13:18 ago)

@ Gopal
Posting: # 14240
Views: 3,471
 

 Waiver of strengths

Dear Gopal
According to the guideline the composition of the strengths need to be quantitatively proportional, i.e. the ratio between the amount of each excipient to the amount of active substance is the same for all strengths in order to regard the additional strength to be the same formulation. Only if the amount of the active substance is less than 5 % of the tablet core weight for both, the BE strength and the lower strength to be waived an exception from this rule can be made:

CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **
If there is some deviation from quantitatively proportional composition, condition c is still considered fulfilled if condition i) and ii) or i) and iii) below apply to the strength used in the bioequivalence study and the strength(s) for which a waiver is considered


Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
silab1001
☆    

Korea,
2015-01-21 13:04
(3354 d 18:08 ago)

@ Dr_Dan
Posting: # 14306
Views: 3,223
 

 Waiver of strengths

Dr Dan,

Just out of curiosity,

❝ Only if the amount of the active substance is less than 5 % of the tablet core weight for both, the BE strength and the lower strength to be waived an exception from this rule can be made


What is the rationale of this 5% criteria? Was there a special reason for this criteria when it was first included in the guideline?

Han
Dr_Dan
★★  

Germany,
2015-01-21 16:57
(3354 d 14:15 ago)

@ Dr_Dan
Posting: # 14307
Views: 3,016
 

 Waiver of strengths

Honestly I have no idea. Significance level? However, you will often find a 5% rule (e.g. with regard to Cmax).
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
112 visitors (1 registered, 111 guests [including 13 identified bots]).
Forum time: 07:12 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5