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Korea,
2019-09-20 10:24

Posting: # 20633
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 Equivalency Studies for Injectables [Design Issues]

Hi.

We're developing an injection product (solution, subcutaneous use).

During our developmental stages, we've changed some manufacturing parts and supplier in between.
We've conduct some clinical studies with the pre-changed product.

We want to conduct a comparative study with the previous product vs. the to-be-marketed product.
In the case for oral dosage forms, we would conduct a comparative dissolution study.

In the case for injection products, how would we show equivalency?
What kind of equivalency studies can we conduct?

Thanks!


Edit: Category changed; see also this post #1[Helmut]
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