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ElMag
Junior

2011-05-11 09:11

Posting: # 7003
Views: 2,256
 

 BE study designs for ANVISA [Regulatives / Guidelines]

Hello!

Can anyone let me know if ANVISA accepts BE study designs recommended only by FDA or can they accept already approved EMA designs?
I've tried to visit their site and your page for guidelines, but all the links were broken. :-(.

Thanks in advance!
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2011-05-11 13:56

@ ElMag
Posting: # 7011
Views: 2,145
 

 BE study designs for ANVISA

Dear ElMag!

» Can anyone let me know if ANVISA accepts BE study designs recommended only by FDA or can they accept already approved EMA designs?

According to the 'old' guidances, nothing special for ANVISA with a few exceptions:
  • Narrow therapeutic index drugs. FDA no restrictions (90% CI within 80–125%), EMA narrower limits on a case-to-case base (90% CI within 90–111%), ANVISA 95% CI within 80–125%.
  • According to presentations by members of ANVISA last May in Ljubljana reference-scaling of Highly Variable Drugs / Drug Products (FDA: AUC, Cmax; EMA: Cmax) is not acceptable.

» I've tried to visit their site and your page for guidelines, but all the links were broken. :-(.

Well, have you seen:

Note: ANVISA is redesigning their website starting in mid-August 2010. Most links are broken with no automatic redirects as of 12 September 2010. We are trying to update links as soon as possible.


I don’t speak Portuguese and don’t know anybody who does. ANVISA’s website was a nightmare from the very beginning and has not improved ever since. :angry:

Cheers,
Helmut Schütz
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Mahesh M
Regular

India,
2018-07-11 09:11

@ Helmut
Posting: # 19030
Views: 197
 

 BE study designs for ANVISA

Dear Helmut,

Do you have any references for below (NTID for ANVISA)

» ANVISA 95% CI within 80-125%.

Regards
Mahesh
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2018-07-11 11:29

@ Mahesh M
Posting: # 19031
Views: 178
 

 History…

Hi Mahesh,

» Do you have any references for below (NTID for ANVISA)
» » ANVISA 95% CI within 80-125%.

Of historical interest only…

Resolution - RE nº 896, of May 29, 2003 (Official Journal of 02/06/2003)
GUIDE FOR BIOEQUIVALENCE STUDIES
3.2 Statistical Analysis
c) analysis of variance (ANOVA) of the pharmacokinetics parameters AUC0-t and Cmax transformed must be carried out in order to evaluate the effects of sequence , of subjects inside the sequence, of period and of treatment. In addition, the ANOVA chart must be presented, containing source, degree of freedom, sum of squares, average square, F statistic, p figure and the intra and inter individual variation coefficients;
d) it is necessary to build a 90% confidence interval (CI) for the difference of the average of the transformed dates obtained with the test and the reference drug products, for the AUC0–t and Cmax parameters. The CI antilogarithm obtained constitutes the CI of 90% for the ratio of the geometrical averages of the parameters.
The construction of this CI must be based on the residual average square of the ANOVA obtained according to item c);
f) two drug products are considered bioequivalents when the 90% CI for the following ratio: AUC0–t,test/AUC0–t,ref and of Cmax,test/Cmax,ref between the average of the pharmacokinetics parameters of the test and reference drugs being inside the 80 and 125%. Other limits of the 90% CI for Cmax, previously established in the protocol, may be accepted through scientific justifications. When clinically relevant, Tmax is also to be considered;
h) for drugs presenting low therapeutical range, such as carbamazepine, valproic acid, clindamycin, and others, a 95% CI must be adopted;


Nothing in the current one.

Cheers,
Helmut Schütz
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