Requirement of temperature data before dosing [Study Per­for­mance]

posted by anky1212 – India, 2017-07-20 08:08  – Posting: # 17567
Views: 4,998

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
 Admin contact
20,134 posts in 4,245 threads, 1,385 registered users;
online 13 (0 registered, 13 guests [including 2 identified bots]).
Forum time (Europe/Vienna): 01:47 CET

A Camel is a Horse designed by committee.    Anonymous

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