Requirement of temperature data before dosing [Study Per­for­mance]

posted by Ohlbe – France, 2017-07-20 09:57  – Posting: # 17568
Views: 4,330

Dear Anky,

What are the recommendation for storage of the IMP ?

If the product is to be kept refrigerated or frozen: yes, this is a problem, and I would not dose the subjects without temperature data.

If not: it depends on the recommendations (below 25°C, below 30°C, or nothing ?), on the stability data that the sponsor has on file (40°C / 70 % HR: e.g. if stable for 3 months but not 6, that's still OK; if unstable after 1 month, could be problematic) and on the duration of shipment.

Regards
Ohlbe

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,880 posts in 4,214 threads, 1,364 registered users;
online 7 (1 registered, 6 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 00:09 CEST

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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