IV: Different half-lives? [Off Topic]

posted by Helmut Homepage – Vienna, Austria, 2024-08-01 15:43 (195 d 09:23 ago) – Posting: # 24122
Views: 2,104

Hi Daborn,

it would be nice to say “hello” or similar in the future.

❝ It's about two intravenous formulations that one of them has longer half-life hence larger exposure.

Half-life (based on \(\small{k_\text{el}}\) – or \(\small{CL}\), if you belong to the other church) is a property of the drug. Can you give more details please?

❝ the guideline I refer to is FDA's "Bioavailability Studies Submitted in NDAs or INDs — Ge­ne­ral Con­si­derations", page 3.

Nothing stated about parenterals in the entire guidance. If you are concerned about the terminology only, use the generic term Comparative Bioavailability Study. Fits to any.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,380 posts in 4,914 threads, 1,661 registered users;
41 visitors (0 registered, 41 guests [including 4 identified bots]).
Forum time: 00:06 CET (Europe/Vienna)

Skill is a function of chance.
It’s an intuitive best-use of chance situations.    Philip K. Dick

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