Bioequivalence and Bioavailability Forum 03:41 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Haemolysed sample identification in BA/BE study and others [Regulatives / Guidelines]

posted by vish14184 - India, 2018-05-09 17:43  - Posting: # 18759
Views: 535

Dear all,

Please share your experience/view on below points. Thank you in advance.

1. Is it acceptable regulatory point of view (AnVIsa, EMA), If we identify haemolysed samples with it's grade (severe, moderate, slightly) during sample receipt in bioanalytical lab instead of haemolysed sample identification at clinical stage during sample separation as per defined procedure in SOP.

2. As per ANVISA requirements: is it required to evaluate ECG by cardiologist in BA/BE Study or ECG evaluation by medical qualified person is acceptable?

3. What is x-ray validity is acceptable for BA/BE Study? One year is acceptable if Ethics committee approving it.

Thank you

With regards
Vishal

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,700 posts in 3,984 threads, 1,238 registered users;
online 12 (0 registered, 12 guests [including 10 identified bots]).

I suppose it is tempting, if the only tool you have is a hammer,
to treat everything as if it were a nail.    Abraham Maslow

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