Gopal ☆ India, 2015-01-07 17:31 (3368 d 13:40 ago) Posting: # 14239 Views: 4,185 |
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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 |
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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 |
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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 |
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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 |