Log in
Register|
Amira ☆ Egypt, 2014-12-15 15:10 (3416 d 23:51 ago) Posting: # 14072 Views: 5,839 |
|
|
When should surfactant be used in Biowaiver media as guidelines state that the 3 pH medias are done without surfactant? Thanks, Edit: Category changed. [Helmut] |
|
Helmut ★★★   Vienna, Austria, 2014-12-15 15:16 (3416 d 23:46 ago) @ Amira Posting: # 14073 Views: 4,816 |
|
|
Hi Amira, never! — 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 |
|
luvblooms ★★ India, 2014-12-16 06:29 (3416 d 08:32 ago) @ Helmut Posting: # 14075 Views: 4,778 |
|
|
Hi Amira/Helmut Which biowaiver we are talking about? a) If BCS based biowaiver to be proposed then NEVER b) If biowaiver for strengths other than bio strength: YES but need to provide sufficient justification/Data for usage of surfactant (especially in case of BCS class II/IV drugs, one have to add surfactant to show complete release) — ~A happy Soul~ |
|
Helmut ★★★ Vienna, Austria, 2014-12-16 15:00 (3416 d 00:02 ago) @ luvblooms Posting: # 14084 Views: 4,636 |
|
|
Hi Luv & Amira ❝ Which biowaiver we are talking about? ❝ a) If BCS based biowaiver to be proposed then NEVER ❝ b) If biowaiver for strengths other than bio strength: YES … I assumed a) because Amira wrote ❝ ❝ as guidelines state that the 3 pH medias are done without surfactant GLs sometimes leave space for interpretation (“should be”, “appropriate”, “if justified”,  ). However, “The use of any surfactant is not acceptable” is unambiguous.— 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 |
|
Amira ☆ Egypt, 2014-12-18 09:35 (3414 d 05:26 ago) @ Helmut Posting: # 14103 Views: 4,578 |
|
|
Thanks all, yes, I meant case a biowaiver. |
Ing. Helmut Schütz