Additional FT? [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2010-08-14 15:20 (5778 d 01:39 ago) – Posting: # 5788
Views: 3,981

Dear Keshav!

❝ […] plasma study samples are to transferred […] under dry ice condition with maintaining required temperature. For this support we are doing one more FT cycle in method validation,


Why? I assume you transfer already frozen samples to the transport boxes / dry ice. No FT should happen here.

❝ […] but it was not fulfill the requirement to observe any physical impact of dry ice to drug in plasma during transfer with dry ice condition.


Can you please specify what exactly you have done? One additional FT cycle, or…?

❝ So for this support, if required Dry Ice Effect experiment during method validation, please answer…


At the Arlington III conference some participants claimed that for some drugs proven stability at -78 ℃ does not grant stability at -20 ℃; but this is extremely counterintuitive.
—
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
23,653 posts in 4,991 threads, 1,570 registered users;
209 visitors (0 registered, 209 guests [including 25 identified bots]).
Forum time: 16:59 CEST (Europe/Vienna)

The epistemological value of probability theory is based on the fact
that chance phenomena, considered collectively and on a grand scale,
create non-random regularity.    Andrey Kolmogorov

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