Bioequivalence and Bioavailability Forum

❝ "The risks of procedures relating solely to research should be explained in the consent document.

The procedures stated here corresponds to any procedures relating solely to research (e.g., randomization, placebo control, additional tests ) See Para 3, Section 21 CFR 50.25 Elements of informed consent

❝ The explanation of risks of the test article should be based upon information presented in documents such as the protocol and/or investigator's brochure, package labeling, and previous research study reports.

The above statement implies that we need to provide all possible risks involved with test article eg., adverse events based on information from protocol, IB, PIL, previous study reports.

❝ it means that the risk involved only after single dose shall be included. does it?

No. We need to provide all possible side effects. The adverse events profile related to single dose administration will not be usually available in the public domain and practically it is not feasible to include only the adverse events occurred in the single dose studies.