Here Are The Crucial Pointers On Bioanalytical Assay Development And Validation For Drug Analysis

During the approval processes like new drug applications (NDAs), investigational new drug applications (INDs) and abbreviated new drug applications (ANDAs), the sponsors require data on bioanalytical assay development and validation. Agencies like the US Food and Drug Administration (FDA), Health Protection Branch (HPB), and Center for Veterinary Medicine (CVM) have taken several steps over the…