Expert Tips To Accurately Perform Your HPLC Method Development & Sample Analysis

A wide variety of operational parameters involving columns, equipment, and eluents generates an adequate level of complexity around high-performance liquid chromatography (HPLC) method development and sample analysis. The nature of an analyte largely influences the HPLC testing protocol. HPLC method consists of five steps, which are; HPLC method and system selection, selection of primary conditions, […]

ich method validation

How Does ICH Guidance Compare To FDA Bioanalytical Method Validation?

The ICH method validation guidelines provide recommendations for quantification and application of bioanalytical assays, both for the chemical and biological drug products. Bioanalytical method development and validation are essential for defining the designing and operating conditions, determining the limitations as well as the suitability of the developed bioanalytical methods. Before developing any bioanalytical CRO method, […]