Bioequivalence and Bioavailability Forum

According to EMEA guidance "If the investigated active substance is known to have adverse effects, and the pharmacological effects or risks are considered unacceptable for healthy volunteers, it may be necessary to include patients
instead, under suitable precautions and supervision."

You must reflect first on the safety profile of the IMP.

Dear kadarusuresh

❝ 1. Study to be conducted on healthy volunteers or patients.

Cytotoxic drug => patients!

❝ 2. What type of study to be conducted like fasting, fed or steady state.

Depends on the drug. In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations. For products where the SmPC recommends intake of the reference medicinal product on an empty stomach or irrespective of food intake, the bioequivalence study should hence be conducted under fasting conditions. For products where the SmPC recommends intake of the reference medicinal product only in fed state, the bioequivalence study should generally be conducted under fed conditions.

❝ 3. what is the right approach for the BE study for EU and US markets.

I suggest in case of BE studies in patients a scientific advice meeting with the regulatory authorities

Hope this helps
Kind regards
Dan