Posting: # 20633
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?
Edit: Category changed; see also this post #1. [Helmut]