Regulated Bioanalysis: Documentation And Reports

The early Crystal City Bioanalytical workshops did not discuss the requirements for bioanalytical documentation and reports. The major bioanalytical guidance from FDA and EMA provided only broad outlines for the requirements in bioanalytical documentation and reports. The bioanalytical practitioners were therefore left to decide what to document in the reports and what to maintain in the archives for inspection. This has led to bioanalytical reports of various shapes and sizes. Parallel to the development of the bioanalytical guidance, ICH developed an electronic Common Technical Document (eCTD) guidance for preparing regulatory reports. Recently, FDA issued a mandatory guidance for submission of data and reports electronically for certain submissions. These latter changes have also been influencing how the bioanalytical data and reports would be submitted in the future. This chapter provides an overview of the bioanalytical documentation and reports for bioanalytical studies intended for regulatory submission.