Format

Send to

Choose Destination
J Pharm Biomed Anal. 1990;8(8-12):613-8.

A practical approach to method validation in pharmaceutical analysis.

Author information

1
Medgenix Group, Fleurus, Belgium, UK.

Abstract

Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodology is now widely required in support of registration dossiers. Although some attempts are made at defining terms and some vague indications are sometimes provided within these guidelines, no clear advice is provided on how validations should be conducted and what results should be expected. In this paper it is attempted to suggest some practical approaches to conducting validation and in particular to the determination of accuracy, linearity and limit of detection/quantitation.

PMID:
2100596
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center