vandee
☆    

Malaysia,
2020-11-23 06:52
(171 d 21:50 ago)

Posting: # 22076
Views: 951
 

 Biowaiver for Lower Strength [Regulatives / Guidelines]

Dear All,

I'd like to seek some advice regarding a specific requirement in the EMA BE guidelines biowaiver:

the amount of the active substance(s) is less than 5 % of the tablet core weight, the weight of the capsule content

Is this criteria applicable for both the BE strength and the lower strength aimed for biowaiver? Can a BE biowaiver for the lower strength be considered if only the lower strength meets this <5% API of tablet core weight requirement? The higher strength has 5.88% of API content per tablet core weight and passed BE. All other biowaiver requirements have been met.

Appreciate any advise i can get on this matter. Thank you very much
Ohlbe
★★★

France,
2020-11-23 10:41
(171 d 18:01 ago)

@ vandee
Posting: # 22077
Views: 816
 

 Biowaiver for Lower Strength

Dear vandee,

» Can a BE biowaiver for the lower strength be considered if only the lower strength meets this <5% API of tablet core weight requirement? The higher strength has 5.88% of API content per tablet core weight and passed BE.

The 5% criterion applies to both strengths, lower and higher.

Regards
Ohlbe
vandee
☆    

Malaysia,
2020-11-25 06:17
(169 d 22:25 ago)

@ Ohlbe
Posting: # 22082
Views: 736
 

 Biowaiver for Lower Strength

» The 5% criterion applies to both strengths, lower and higher.

Dear Ohlbe,
Thank you for this. Appreciate it


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
wienui
★    

Germany, Oman,
2020-11-24 10:42
(170 d 18:00 ago)

(edited by wienui on 2020-11-24 11:09)
@ vandee
Posting: # 22081
Views: 787
 

 Biowaiver for Lower Strength

Hi Vandee & Ohlbe,

As Ohlbe said, according to EMA for an additional strength biowaiver, the Amount of API(s) must be < 5% of tablet (capsule) core weight for both strengths, the BE strength and the biowaiver one.
Moreover, the Amounts of excipients are the same per strength or Only the amount of a filler is changed to account for changes in API weight.

The FDA doesn't consider this 5% rule and the requirements for an additional strength biowaiver are as following:
  • Total weight of dosage form nearly the same for all strengths
  • Same inactive ingredients in each strength
  • Change in strength obtained by varying active and one or more inactive ingredients
Both EMA & FDA are asking for the Similarity of dissolution characteristics of the biowaiver strength to the strength for which bioequivalence has been demonstrated in vivo.


I hope this could help.

Cheers,
Osama
vandee
☆    

Malaysia,
2020-11-25 06:21
(169 d 22:21 ago)

@ wienui
Posting: # 22083
Views: 731
 

 Biowaiver for Lower Strength

» The FDA doesn't consider this 5% rule and the requirements for an additional strength biowaiver are as following:
»
» – Total weight of dosage form nearly the same for all strengths
» – Same inactive ingredients in each strength
» – Change in strength obtained by varying active and one or more inactive ingredients
»
» Both EMA & FDA are asking for the Similarity of dissolution characteristics of the biowaiver strength to the strength for which bioequivalence has been demonstrated in vivo.

Dear Osama,
This is indeed very helpful. I will justify my biowaiver using the USFDA approach in hopes that regulators here (ASEAN) will accept. Thank you very much for your advise.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
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