Bioequivalence and Bioavailability Forum

Dear esreddy,

ANVISA stated (May 2003):
i) according to the drug product, the studies may be conducted in volunteers aged between 18 and 50 and capable of providing their free and informed consent, male, female or both, in which case the number of men and women must be the same and distributed equally between the sequences.
j) the weight of the subjects must be within a limit of ± 15% of the weight considered normal for men and women, considering height and physical structure.
k) smokers and subjects with a history of alcohol and drug abuse must be avoided. In case smokers are included, these subjects must be identified.
l) in the case of studies requiring subjects with different characteristics from those previously mentioned, their inclusion must be scientifically justified.
m) cytotoxic drug products must be tested on voluntary patients, suffering from the pathology for which the drug product is indicated, with their free and informed consent or that of their legal representative, in case of incapability of the patient.

A new regulation was published on 19 Apr 2006; as far as I can see (I do not speak Portuguese) points mentioned above did not change.