Quality Management Standards for Drug Clinical Trials

Quality Management Standards for Drug Nonclinical Research

Guidelines for the Management of Biological Sample Analysis Laboratory for Drug Clinical Trials (Trial)

Guiding Principles for Validation of Quantitative Analysis Methods of Biological Samples (2015 Chinese Pharmacopoeia)

Requirements for the Application of New Registration Classification of Chemical Drugs (Trial)

Drug Data Management Specification (Draft for Comment)

FDA. Guidance for Industry - Bioanalytical Method Validation. 2018.05.
FDA. Guideline on Bioanalytical Method Validation. 2012.02.
FDA. Immunogenicity Testing of Therapeutic Protein Products-Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry. 2019.01.
FDA. Guidance for Industry-Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products. 2016.04.
FDA. Good Laboratory Practice for Nonclinical Laboratory Studies. 21 CFR Part 58.