Shreekant Karmarkar is a senior research scientist at Baxter.
Evaluating Progress in Analytical Quality by Design
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach
A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.