References
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH M10: Bioanalytical Method Validation and Study Sample Analysis. (2022). https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf
- oecd series on principles of good laboratory practice and compliance monitoring. Number 22. Advisory Document of the Working Party on Good Laboratory Practice on GLP Data Integrity. https://one.oecd.org/document/ENV/CBC/MONO(2021)26/en/pdf
- Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry. Draft Guidance for Industry. (2022). www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-antibody-drug-conjugates-guidance-industry
- Japan Bioanalysis Forum. The 14th JBF symposium: program. https://bioanalysisforum.jp/en/topics/img/pdf/14thJBF_Sympo_PG_E-2.pdf