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

posted by vish14184 – India, 2018-05-09 17:43 (1304 d 01:38 ago) – Posting: # 18759
Views: 1,452

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:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 7 (0 registered, 7 guests [including 5 identified bots]).
Forum time: Friday 18:21 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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