Bioequivalence and Bioavailability Forum

❝ Can somebody confirm that the upper age limit (i.e. 50 years of age) is really required for a BE study according to the current ANVISA regulation?

Dear Mr PP,
As per ANVISA Resolution - RE nº 896, Guide For Relative Bioavailability/Bioequivalence Tests Of Drug Products "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.

Hence, the upper limit of age is 50 years as per ANVISA.