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, […]


How To Approach Analytical Method Transfer For Streamlined Drug Development

The drug development process is a lengthy and challenging exercise. In most cases, the pharmaceutical company out-sources either the complete developmental process or a part of it to single or multiple laboratories. Analytical method transfer A laboratory that develops and validates an analytical method does not always perform the testing procedure. The parent laboratory may transfer the […]


What You Need To Learned About Analytical Method Transfers In Various Stages Of Drug Development?

Analytical method transfers are referred to as documented processes of qualifying a laboratory so that it can utilize a validated analytical procedure which has been originated or developed in some other laboratory. It is a pre-requisite for the receiving laboratory to possess the procedural knowledge and analytical testing performing ability as intended in the concerned […]