What is typically advised when conducting bioequivalence studies for a generic product?

When conducting bioequivalence studies for a generic product, it is commonly advised to refer to the original product manufacturer's file for the rest of the documentation. This practice allows for a comprehensive understanding of the reference listed drug (RLD) characteristics, including formulation, bioavailability, and pharmacokinetic data. By utilizing information from the original manufacturer's file, researchers can ensure that their study aligns with the established data for the RLD, facilitating the necessary comparisons needed to demonstrate bioequivalence.

This approach also supports adherence to regulatory requirements, as it is essential for the generic product to demonstrate that it is therapeutically equivalent to the RLD. The details obtained from this file can inform study design, support the selection of appropriate endpoints, and assist in assembling a robust regulatory submission package. Ultimately, leveraging the original manufacturer's documentation not only helps justify the bioequivalence claims but also plays a crucial role in ensuring patient safety and efficacy.