Freshly prepared Vs freshly spiked [Bioanalytics]

posted by Ramesh – India, 2018-06-20 19:14 (2282 d 18:25 ago) – Posting: # 18935
Views: 1,687

Hi,

In current FDA guideline it has been stated freshly prepared CC and QC, freshly spiked CC and QC.

In case of freshly prepared or freshly spike, can master stock of proven stability can be used.

with regards,

Ramesh

Complete thread:

UA Flag
Activity
 Admin contact
23,228 posts in 4,879 threads, 1,652 registered users;
38 visitors (0 registered, 38 guests [including 9 identified bots]).
Forum time: 13:39 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

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