White Papers related to Clinical Biostatistics
White Paper
In the rapidly evolving world of regulatory requirements, navigating local affiliate pharmacovigilance can be challenging. Our expert guide provides you with detailed frameworks, insights, and best practices that are helping biopharma companies establish and maintain compliance with these complex requirements.
White Paper
Before undertaking a validation attempt of an analytical method, it is important to think about the experimental design. In this white paper we go into some theoretical aspects and requirements needed to estimate the optimal experimental design from a cost vs. risk perspective. As a starting point and principle we use the Total Analytical Error (TAE) which we believe is the future of analytical method validation, and which is also slowly getting its way into the governing guidelines of analytical method validation such as ICH Q2(R2), ICH Q14 and USP <1220>.