1. International Conference on Harmonization. Guidance for industry. Q5E: comparability of biotechnological/biological products subject to changes in their manufacturing process. 2005. https://doi.org/www.fda.gov/Regulalorylnformation/Guidances/ucm128059.htm#f4.
2. Food and Drug Administration. Guidance for industry: changes to an approved application for specified biotechnology and specified synthetic biological products. 1997. https://doi.org/www.fda.gov/downloads/Drugs/GuidanceComplianceReguIatorylnformation/Guidances/UCM124805.pdf.
3. Title 21 Code of Federal Regulations (21 CFR), sections 314.70 and 601.12.
4. Bauman A. Early development of therapeutic biologies—pharmacokinetics. Curr Drug Metab. 2006;7:15–21.
5. International Conference on Harmonization. Guidance for industry: Q6B specifications: test procedures and acceptance criteria for biotechnological/biological products, https://doi.org/www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073488.pdf.