Equivalency Studies for Injectables [Design Issues]

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


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]

Complete thread:

 Admin contact
21,026 posts in 4,382 threads, 1,460 registered users;
online 12 (0 registered, 12 guests [including 10 identified bots]).
Forum time: Saturday 01:08 CEST (Europe/Vienna)

It has yet to be proven
that intelligence has any survival value.    Arthur C. Clarke

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz