Considerations for the Preclinical Safety Evaluation of Biopharmaceuticals

Comprehensive Toxicology, Second Edition

Volumn 3, Issue , 2010, Pages 29-51

  Cavagnaro, J ^a  

^a Access BIO ^*  (United States)

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EID: 85012831300     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-08-046884-6.00308-0     Document Type: Chapter

References (45)

1. Bass R., Kleeburg U., Schroder H., Scheibner E. Toxicol. Lett. 1991, 64-65:339-347.
2. Brennan F.R., Shaw L., Wing M.G., Robinson C. Mol. Biotechnol. 2004, 27:59-74.
3. Bugelski P.J., Sachs C., Cornacoff J., Martin P., Treacy G. Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials 2008, 601-632. John Wiley & Sons, New Jersey, NJ. J. Cavagnaro (Ed.).
4. Cavagnaro J.A. Pharm. Eng. 1992, 12:32-33.
5. Cavagnaro J.A. Biologics Development: A Regulatory Overview 1993, 23-40. Parexel International Corp, Waltham, MA. M. Mathieu (Ed.).
6. Cavagnaro J.A. Nat. Rev. Drug Discov. 2002, 1:469-475.
7. Cavagnaro J. Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials 2008, 399-477. John Wiley Sons, New Jersey, NJ. J. Cavagnaro (Ed.).
8. Cavagnaro J. Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials 2008, 45-65. John Wiley & Sons, New Jersey, NJ. J. Cavagnaro (Ed.).
9. Cavagnaro J.A., Spindler P. Hum. Exp. Toxicol. 2000, 19:213-215.
10. Clarke J., Hurst C., Martin P., Vahle J., Ponce R., Mounho B., Heidel S., Andrews L., Reynolds T., Cavagnaro J. Regul. Toxicol. Pharmacol. 2008, 50:2-22.
11. Claude J.R. Toxicol. Lett. 1992, 64/65:349-355.
12. Dayan A.D. BIRA J. 1990, 9:7-10.
13. Dayan A.D. Toxicology 1995, 105:59-68.
14. Early Stage Clinical Trial Taskforce. Joint ABPI/BIA Report, (accessed 2 July 2006). http://www.abpi.org.uk/information/pdfs/BIAABPI_taskforce2.pdf.
15. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. (accessed July 2005). http://www.fda.gov/CDER/guidance/5541fnl.htm.
16. Expert Scientific Group on Phase One Clinical Trials. Final Report ("Duff Report"), (accessed January 2010). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065007.htm.
17. Giezen T.J., Mantel-Teeuwisse A.K., Straus S.M.J.M., Schellekens H., Leufkens H.G.M., Egberts A.C.G. J. Am. Med. Assoc. 2008, 300:1887-1896.
18. Gocke E., Albertini S., Brendler-Schwaab S., Muller L., Suter W., Wurgler F.E. Mutat. Res. 1999, 436:137-156.
19. Goldenthal, E. I. Current Views on Safety Evaluation of Drugs. FDA Papers, May 1968.
20. Haller C.A., Cosenza M.E., Sullivan J.T. Clin. Pharmacol. Ther. 2008, 84:624-627.
21. Hayes T.J., Cavagnaro J.A. Toxicol. Lett. 1992, 64/65:291-297.
22. ICH Draft Consensus. Guideline Nonclinical Evaluation for Anticancer Pharmaceuticals-S9 (Step 2). (accessed January 2010). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065007.htm.
23. ICH Harmonised Tripartite. Guideline Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals-M3(R2) (Step 2). (accessed July 2008). http://www.ich.org/LOB/media/MEDIA4744.pdf.
24. ICH S5A. Detection of Toxicity to Reproduction for Medicinal Products. (accessed January 2010). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065007.htm.
25. ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, 1997. (accessed January 2010). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065007.htm.
26. Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1), 2009.
27. Jacobson-Kram D., Ghantous H. Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials 2008, 337-341. John Wiley & Sons, New Jersey, NJ. J. Cavagnaro (Ed.).
28. Leonard J.P., Sherman M.T., Fisher G.L., Buchanan L.J., Larsen G., Atkins M.B., Sosman J.A., Dutcher J.P., Vogelzang N.J., Ryan J.L. Blood 1997, 90:2541-2548.
29. Mahmood I., Green M.D. J. Clin. Pharmacol. 2007, 47:1540-1554.
30. Martin P., Breslin W., Rocca M., Wright D., Cavagnaro J. Birth Defects Res. 2009, 33:176-203.
31. Mires-Sluis A.R., Barrett Y.C., Devanarayan V., Koren E., Liu H., Maia M., Parish T., Scott G., Shankar G., Shores E., et al. J. Immunol. Methods 2004, 289:1-16.
32. Nakazawa T., Kai S., Kawai M., Maki E., Sagami F., Onodera H., Kitajima S., Inoue T. J. Toxicol. Sci. 2004, 29:497-504.
33. Questions and Answers on the Federal Register Notice on Drugs and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies, 2008. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm095439.htm.
34. Rosenblum I.Y., Dayan A.D. Hum. Exp. Toxicol. 2002, 21:347-358.
35. Ryan A.M., Terrell T.G. Handbook of Toxicologic Pathology 2002, 479-500. Academic Press. 2nd ed.
36. Seitz K., Zhou H. J. Clin. Pharmacol. 2007, 47:1104-1118.
37. Serabian M.A., Pilaro A.M. Toxicol. Pathol. 1999, 27:27-31.
38. Sims J. Toxicol. Lett. 2001, 120:59-66.
39. Snodin D.J., Ryle P.R. Biodrugs 2006, 1:25-52.
40. Terrell T.G., Green J.D. Toxicol. Pathol. 1994, 22:187-193.
41. Thomas J.A. Toxicology 1995, 105:7-22.
42. Verdier F. Preclinical Safety Assessment of Vaccines in Biotechnology and Safety Assessment 2002, 397-412. Academic Press, San Diego, CA. 3rd ed. J.A. Thomas, R.L. Fuchs (Eds.).
43. Walsh G. Current Status of Biopharmaceuticals: Approved Products and Trends in Approval in Modern Biopharmaceuticals 2005, Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, Germany. J. Knablein (Ed.).
44. Zbinden G. Drug Saf. 1990, 5(Suppl. 1):58-64.
45. Zbinden G. Regul. Toxicol. Pharmacol. 1991, 14:167-177.