Spring Intro 2023

16/02/2023

Establishing Bioequivalence

Lots of “what ifs” that influence study design. Commonly: • Completed in healthy volunteers • Cross-over studies with a washout period in between • Undertaken under fasting conditions • Single dose only • Completed in 12 to 80 subjects

…BUT there are many scenarios where different study designs apply.

• Highest strength only • Analyte is parent drug

The Organisation for Professionals in Regulatory Affairs

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Waiving Bioequivalence Studies

Article 10(2)(b), Directive 2001/83/EC: Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines. There are certain scenarios where a BE study can be waived. Examples: • Specific strengths (where biowaiver criteria are met) • BCS class I and III compounds (highly soluble drug substances) • Orally administered solutions (usually…) • Parenteral products (potential exceptions: colloids/complexes and MR)

The Organisation for Professionals in Regulatory Affairs

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