Using Computer Simulated Results of a Bulk Drug Substance Assay to Determine Acceptance Criteria for Method Validation

1 January 1997

journal article
Published by Springer Nature in Pharmaceutical Research

Vol. 14 (2) , 156-163
https://doi.org/10.1023/a:1012088308307

Abstract

Purpose. To determine the statistical variability expected for a well designed HPLC assay of a bulk drug substance (BDS). The results are used to develop appropriate acceptance criteria for a method...

Keywords

MODELING
VALIDATION
SIMULATIONS
ASSAY
COMPUTER
ACCEPTANCE CRITERIA
BDS
VARIABILITY EXPECTED

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National Practitioner Data Bank: change in user fee.
1995