Bioequivalence and Bioavailability Forum

Dear Mr Pravin,

As per Canadian Guidelines, If possible, the study should be conducted in such a way that the subject is not aware of which product (test or reference) is being administered. Furthermore, the person checking for adverse reactions and the person conducting the analysis of samples should not know which product was administered. Other individuals involved in the administration of the drugs, the surveillance of the patients, or the analysis of plasma data should not know which product was administered.

Reference

Dear Mr Pravin,

section 4.10 Identification of Adverse Reactions and Side Effects

as per guidelines

In some cases, adverse drug reactions are due to factors other than the active ingredient in a formulation. The rate of absorption and excipients within formulations may affect the frequency,onset, and severity of adverse drug reactions. The incidence, severity, and duration of adverse reactions and side effects observed during the study must be reported. The probability that an adverse effect is drug-induced is to be judged by the investigator.
The same observer and format for eliciting and recording information on adverse drug reactions should be used for all subjects. Questions concerning adverse reactions and side effects should be asked on each study day by the "blinded" observer.

6.9 Quality Control for Spiked Samples

A minimum of six QC samples, composed of three concentrations in duplicate, must be blinded and analysed with each batch of study samples for each analytical day or run.

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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! [Helmut]

Hi,

I ran a study for Canadian submission before and it was single blinded. However, my company has submitted US open-label BE studies and the studies were accepted by TPD (Canada). Yes the studies used Canadian reference products but were FDA open-label study design.

John