linear or nonlinear pharmacokinetics of lyme­­cyclin [PK / PD]

posted by Mauricio Sampaio  – Brazil, 2013-09-07 03:18 (4323 d 03:14 ago) – Posting: # 11454
Views: 6,849

Hi Dan

I did not expressed myself as I wanted in my last post. What I meant is that I have a possibility to biowaiver of 150 mg strength based on the data of 300 mg lymecycline, because they will come from tetracycline (that has linear PK). In Brazil Tetralysal is marketed in the two forces. Therefore, the bioequivalence study of 300 mg can support a bioiwaiver to smallest strength of 150 mg since the test formulations are proportionate and in vitro profiles of lymecycline are similar.

Did you understand me now? :-)

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,695 registered users;
73 visitors (0 registered, 73 guests [including 21 identified bots]).
Forum time: 06:32 CEST (Europe/Vienna)

If I’d observed all the rules,
I’d never have got anywhere.    Marilyn Monroe

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