Consideration for the validation of clinical laboratory methods in nonclinical fields

In new drug development, cells or animals are treated with the selected candidate compound to confirm its efficacy and safety in nonclinical studies. Clinical laboratory tests are carried out using samples from experimental animals in these studies. The clinical laboratory test method validation in...

Full description

Saved in:
Bibliographic Details
Published in:Bioanalysis 2022-11, Vol.14 (21), p.1337-1348
Main Authors: Minomo, Hirofumi, Inoue, Yoshimi, Iwachido, Takako, Oota, Hiromi, Otabe, Koji, Kubono, Katsuo, Kondo, Satoshi, Sasaki, Daisuke, Suzuki, Yusuke, Nakamura, Yuta, Naraoka, Hitoshi, Higashiyama, Masumi, Fujisawa, Nozomi, Honda, Kumi, Matsumoto, Tadao, Yasui, Hideki, Saito, Yoshiro, Toyota, Naoto
Format: Article
Language:English
Subjects:
clinical laboratory
clinical pathology
nonclinical
validation
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:In new drug development, cells or animals are treated with the selected candidate compound to confirm its efficacy and safety in nonclinical studies. Clinical laboratory tests are carried out using samples from experimental animals in these studies. The clinical laboratory test method validation in nonclinical fields should be conducted keeping in mind that the circumstances differ from those in clinical settings. However, the validation procedures have not been systematically integrated into any standard. The considerations in this paper set out systematically practical guidance for the validation of quantitative analytical methods for fluid samples collected from animal studies, for the purpose of ensuring that laboratory test method validation is conducted in nonclinical fields at an enough level.
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2022-0178