Abstract
A Novel UPLC–MS/MS Method for Determination of γ-Amino Butyric acid Analogue in Human Plasma: Application to Pharmacokinetic StudyAnju Aji, Sarita Karthikeyan, Sarabjit Singh, Shivanand P. Puthli
Highlights
This document is complementary to the ICH guidance entitled Text on Validation of Analytical Procedures (ICH Q2A), which presents a discussion of the characteristics that should be considered during the validation of analytical procedures
It is important to remember that the main objective of validation of an analytical procedure is to demonstrate that the procedure is suitable for its intended purpose
At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and the United States
Summary
This document is complementary to the ICH guidance entitled Text on Validation of Analytical Procedures (ICH Q2A), which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. It is usually possible to design the experimental work such that the appropriate validation characteristics can be considered simultaneously to provide a sound, overall knowledge of the capabilities of the analytical procedure, for instance: Specificity, linearity, range, accuracy, and precision.
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