ilee9009
☆    

Korea,
2019-09-20 10:24
(683 d 16:10 ago)

Posting: # 20633
Views: 1,340
 

 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]
Activity
 Admin contact
21,606 posts in 4,517 threads, 1,532 registered users;
online 15 (0 registered, 15 guests [including 4 identified bots]).
Forum time: Wednesday 02:35 CEST (Europe/Vienna)

Scientists cannot simply hang their subjectivities
up on a hook outside the laboratory door.    Ruth Bleier

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5