1. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-chapter 3: Pig islet product manufacturing and release testing;Korbutt;Xenotransplantation,2009
2. U.S. Food and Drug Administration Guidance for Industry Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans 2003 http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceCompliance
3. U.S. Food and Drug Administration Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products: Notice 1993 58 FR 53248 1993 http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/UCM148113.pdf
4. International Conference on Harmonization Guidelines Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 1999 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
5. International Conference on Harmonization Guidelines Q5D Quality of Biotechnological/Biological Products: Derivation, Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products 1997 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5D/Step4/Q5D_Guideline.pdf