Long term stability [Bioanalytics]

posted by deepakpangavhane – India, 2019-01-09 13:54 (829 d 09:35 ago) – Posting: # 19762
Views: 3,600

(edited by mittyri on 2019-01-09 15:56)

Dear Experts

I have required long term stability data proved with an old method. However during validation of old method, second analyte i.e. metabolite was not spiked in presence of parent analyte.
Whereas study plasma samples contains both parent analyte and metabolite in them.

I have developed and validated new method (changes primarily include: SPE cartridge make change; change in concentration range from 10-5000 pg/mL to 10-4000 pg/mL; parent analyte spiked in plasma in presence of metabolite for all experiments) and perfromed study sample analysis with new method.

However I am unable to finish LTS experiment for required duration with new method.

Can I use long term stability data of old method as supportive data for my usfda study submission?



Edit: Category changed; see also this post #1[Mittyri]

Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,511 registered users;
online 16 (0 registered, 16 guests [including 6 identified bots]).
Forum time: Sunday 00:29 CEST (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

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