Sulfasalazine: My study [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-05-28 10:04  – Posting: # 20304
Views: 719

Hi Irene,

» Have anyone here ever conducted Bioequivalence study of Sulfasalazine?

Yes. My results (T1: 1×4 500 mg IR, T2: 1×4 500 mg enteric coated, R: 2,000 mg suspension, six-sequence Williams’ design, sampling for 60 hours, washout two weeks, 24 eligible subjects, plasma and urine). This study was performed for the originator. Both test products showed lower bioavailabilities of sulfasalazine and 5-ASA, whereas sulfapyridine and N-acetylsulfapyridine were BE. CVs for plasma:Given the high variabilities of Sulfasalazine and 5-ASA I suggest reference-scaling.

Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,688 posts in 4,178 threads, 1,353 registered users;
online 11 (0 registered, 11 guests [including 10 identified bots]).
Forum time (Europe/Vienna): 18:03 UTC

Power. That which statisticians are always calculating
but never have.    Stephen Senn

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5