Single study with two different RLD / Sub­mission [Regulatives / Guidelines]

posted by Pharma_88 – India, 2026-04-30 06:46 (34 d 19:18 ago) – Posting: # 24611
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Dear Team,

Would like to have an opinion for a study (3WCO) with two different RLD (US & EMA).

As per my knowledge, this will be a T, R1, R2 (3 sequences) study where we need to prove bioequivalence of T/R1 and T/R2. Right?

Furthermore, would also like to know whether a separate Fast and Fed study is required or if there is any other design that can be opted to cover both conditions in a single study with two RLD?

Looking forward to hearing.
—
Regards,
Pharma_88

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