Requirement of temperature data before dosing [Study Per­for­mance]

posted by anky1212 – India, 2017-07-20 06:08  – Posting: # 17567
Views: 4,946

Hi All,

Please note following scenario,

Sponsor going to ship IP today but sponsor is not able to sent temperature data during shipment of product to CRO. Dispensing has been done without having temperature data during shipment. Tommorrow, there is dosing of subject.

Is it any concern for dispensing as well as dosing of subject even though temperature data during shipment not available?

Please provide your view on above scenario (along with guidance if available).

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
20,002 posts in 4,231 threads, 1,376 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 03:28 UTC

It is a well-known experience that the only truly enjoyable and
profitable way of studying mathematics is the method of
“filling in details” by one’s own efforts.    Cornelius Lanczos

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