Bioequivalence and Bioavailability Forum

rasheed ☆ 2010-04-08 14:34 (5913 d 04:31 ago) Posting: # 5037 Views: 6,007	Bioequivalence conclusion [General Statistics] Post reply
	Some time there are instances in bioequivalence where one of the 90% confidence limit is not falling in the range (80%- 125%), so in this situation can bioequivalence be concluded? And how many PK parameters (AUC, Cmax, tmax) are required to conclude the bioequivalence or can we make conclusion of bioequivalence only on the basis of AUC? Edit: Category changed. Please see the Policy. [Helmut]

bharat
☆

India,
2010-04-08 15:48
(5913 d 03:16 ago)

@ rasheed
Posting: # 5039
Views: 4,645

Bioequivalence conclusion

Post reply

❝ Some time there are instances in bioequivalence where one of the 90%

❝ confidence limit is not falling in the range (80%- 125%), so in this

❝ situation can bioequivalence be concluded?

Yes for all BE Study You have to conclude the Bioequivalence. If it is not falling in the range then it (test with reference) will be not bioequivalent

❝ And how many PK parameters (AUC, Cmax, tmax) are required to conclude the

❝ bioequivalence

For most of the countries it is concluded on primary parameters

❝ or can we make conclusion of bioequivalence only on the basis of AUC?

No, you can't give the conclusion on the basis on only AUC.
If you have any question pls. revert me

Regards
Bharat

Helmut
★★★

Vienna, Austria,
2010-04-08 17:58
(5913 d 01:06 ago)

@ bharat
Posting: # 5047
Views: 4,938

BE (tmax, early exposure)

Post reply

Dear Bharat and Rasheed!

❝ ❝ And how many PK parameters (AUC, Cmax, tmax) are required to conclude

❝ ❝ the bioequivalence

❝

❝ For most of the countries it is concluded on primary parameters

Right, but what’s primary?

US-FDA: C_max, AUC_inf and AUC_t; if clinically important, early exposure (AUC truncated at median t_max of the reference)
EU-EMA: C_max, AUC_t (no AUC_inf!)
Canada-HPB/TGD: AUC_t and the T/R ratio of C_max within 80%-125% (no confidence interval); if clinically important, T/R-ratio of AUC truncated at median t_max of the reference (no confidence interval)
...

It is always important to study the guidelines of the target country.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

rasheed ☆ 2010-04-13 08:08 (5908 d 10:56 ago) (edited on 2010-04-13 11:57) @ bharat Posting: # 5100 Views: 4,543	Bioequivalence conclusion Post reply
	Dear Bharat I asked, in the situation where one of confidence limit is outside the range 80%-125% so what we conclude? and how many parameter require for bioquivalence ? Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Bioequivalence conclusion [General Sta­tis­tics]

Bioequivalence conclusion

BE (tmax, early exposure)

Bioequivalence conclusion

Bioequivalence conclusion [General Statistics]