Log in
Register|
ramesh_7779 ★ 2011-06-25 12:54 (5067 d 20:26 ago) Posting: # 7173 Views: 6,462 |
|
|
Dear All, Can anbody tell how to about Bioequivalence Study of Sulfasalazine. https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfasalazine_DRtab_07073_RC2-10.pdf other than this literature. Regards Raja |
|
Helmut ★★★   Vienna, Austria, 2011-06-25 15:18 (5067 d 18:02 ago) @ ramesh_7779 Posting: # 7174 Views: 6,055 |
|
|
Dear Ramesh, the usual question: for which country? If you want to go to the US, ask the FDA’s review staff whether reference-scaling is acceptable. In conventional 2×2 cross-over studies we found sulfasalazine and 5-ASA to be highly variable (CVintra 40–50 %; both for AUC and Cmax). Other metabolites were nicer (sulfapyridine ≈13 %, N-acetyl-sulfapyridine ≈8 %, N-acetyl-5-ASA ≈23 %) – but the FDA is not asking for them. If you are thinking to opt for urine, forget it: sulfasalazine 60-70 %, sulfapyridine 15-25 %, N-acetyl-sulfapyridine 23-30 %, hydroxy-sulfapyridine 25-30 %, hydroxy-N-acetyl-sulfapyridine 20-25 %). For the EMA you have to go with the parent. Convincing them that sulfasalazine is a pro-drug (I would say so) would not help because 5-ASA is highly variable as well. Scaling is acceptable for Cmax only… — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
dshah ★★ India, 2024-10-15 08:05 (207 d 01:15 ago) @ Helmut Posting: # 24231 Views: 1,529 |
|
|
Hi Helmut! Can you share the link of source having 90% CI or ISCV? Divyen |
|
Helmut ★★★ Vienna, Austria, 2024-10-15 11:03 (206 d 22:17 ago) @ dshah Posting: # 24233 Views: 1,526 |
|
|
Hi Divyen, ❝ Can you share the link of source having 90% CI or ISCV? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
|
dshah ★★ India, 2024-10-16 08:16 (206 d 01:04 ago) @ Helmut Posting: # 24234 Views: 1,491 |
|
|
HI Helmut! I can understand. Thank you. I am just wondering about IV administration as mentioned in label for Vd. I am struggling to find the IV profile in human. Has anyone came across IV Sulfasalazine? Divyen |
Ing. Helmut Schütz