History… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-07-11 11:29 (1287 d 14:28 ago) – Posting: # 19031
Views: 1,975

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)
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.

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Helmut Schütz

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