Internal Standards (IS) Monitoring in CROs: Anvisa Perspective

Crucial Importance of Evaluating Internal Standards (IS) Response and Troubleshooting in Effective LCMS Method Development, Validation and Sample Analysis

“…It describes the crucial role inspections play in the regulatory process and invites the reader to consider the impact IS response variations can have on bioanalytical data. Alongside this, Gustavo Mendes Lima Santos and Eduardo Fernandes (Brazilian Health Regulatory Agency [ANVISA]; Brasilia, Brazil) discuss the perspective of the ANVISA and their regulation monitoring [9]. Specifically, this article considers requirements regarding IS monitoring in CROs.…”