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RLD and RS

#1 · September 19, 2024, 12:48 am

What is the difference between RLD & RS?

When should consider RLD and when RS?

#2 · September 19, 2024, 2:07 pm

A reference listed drug (RLD) is the listed drug identified by FDA as the drug product which is referred to a generic drug manufacturer to compare between RLD and Test product.

A reference standard (RS) is the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study.

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#3 · September 19, 2024, 4:05 pm

Is it mandatory to collect the RLD/RS from same market for regulatory approval?

#4 · September 22, 2024, 12:52 am

It’s mandatory for most of the highly regulated market to collect the RLD from same market.

But few regulatory body also satisfy with RLD from same manufacturer from different market.

So, it depends on the regulatory requirement of your target market.

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