Equivalency Studies for Injectables [Design Issues]

posted by ilee9009 – Korea, 2019-09-20 10:24 (329 d 14:43 ago) – Posting: # 20633
Views: 967

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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