Doubts regarding IS variation, ISR failure & SEL/SPE Acceptance criteria [Regulatives / Guidelines]

posted by Rams69  – Madruai, Tamilnadu, India, 2021-05-12 06:57 (204 d 20:44 ago) – Posting: # 22340
Views: 1,075

Dear All,

Greetings,

I have few doubts regarding the following,

1) Why we are fixing IS variation range ±50% from the average IS response of accepted CCs &
QCs. (while using a dutrated IS why we not keeping ±15% or ±20% or some other range).
2) If in one project ISR failure observed frequently/continuesly means what will go to next
actions and please give some exaples with clarification for the reasons for those
failures.
3) As per new guideline in Selectivity and Specificity for analyte interference in blank
samples were comparing with the speific lot LLOQ response (Which lot used for BLK & LLOQ
Preparation) but why the ISTD response of the balnk samples were comparing with the
average response of accepted CCs & QCs why not comparing with respective LLOQ ISTD
response.Please clarify.

Thank You,

Information is Wealth,
Thangairulappan S

Complete thread:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 8 (0 registered, 8 guests [including 6 identified bots]).
Forum time: Friday 02:42 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