The Principles of ICH S6 and the Case-by-Case Approach

Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials

Volumn , Issue , 2007, Pages 43-65

  Cavagnaro, Joy A ^a  

^a Access BIO   (United States)

Author keywords

ICH S6 and case by case approach; Preclinical safety evaluation and ICH S6; Toxicology practice and rational science based approach

Indexed keywords

EID: 84885378237     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470292549.ch3     Document Type: Chapter

References (40)

1. Olson H, Betton G, Robinson D, Thomas K, Monro A, Kolaja G, Lilly P, Sanders J, Sipes G, Bracken W, Dorato M, Van Deun K, Smith P, Berger B, Heller A. Con cordance of the toxicity of pharmaceuticals in humans and animals. Regul Toxicol Pharmacol 2000; 32: 56-67.
2. Goldenthal EI. Current views on safety evaluation of drugs. FDA Papers May 1968.
3. Hayes TJ, Cavagnaro JA. Progress and challenges in the preclinical assessment of cytokines. Toxicol Letts 1992; 64 / 65: 291-7.
4. Zbinden G. Biotechnology Products Intended for Human Use, Toxicological Targets and Research Strategies. In CE Grahm (ed) Preclinical Safety of Biotechnology Products Intended for Human Use: Clinical and Biological Research, Vol. 235, Alan R. Liss, New York, 1987, pp 143-59.
5. Giss HE. Foreword. In CE Grahm (ed) Preclinical Safety of Biotechnology Products Intended for Human Use: Clinical and Biological Research, Vol. 235, Alan R. Liss, New York, 1987, pp xiii-xv.
6. Dayan AD. Rationality and regulatory requirements - A view from Britain. In CE Grahm (ed) Preclinical Safety of Biotechnology Products Intended for Human Use: Clinical and Biological Research, Vol. 235, Alan R. Liss, New York, 1987, pp 89-106.
7. Galbraith WM. Symposium discussion. In CE Grahm (ed) Preclinical Safety of Biotechnology Products Intended for Human Use: Clinical and Biological Research, Vol. 235, Alan R. Liss, New York, 1987, pp 189-206.
8. Finkle BS. Genetically engineered drugs: Toxicology with a difference. In CE Grahm (ed), Preclinical Safety of Biotechnology Products Intended for Human Use: Clinical and Biological Research, Vol. 235, Alan R. Liss, New York, 1987, pp 161-7.
9. Griffith SA, Lumley CE. Non-clinical safety studies for biotechnologically-derived pharmaceuticals: Conclusions for an International workshop. Hum Exper Toxicol 1998; 17: 63-83.
10. ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. http://www.fda.gov/cder/guidance/index.htm.
11. ICH M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals. http://www.fda.gov/cder/guidance/index.htm.
12. DeGeorge JJ, Ahn C-H, Andrews PA, Brower ME, Giorgio DW, Goheer MA, Lee-ham DY, McGuinn WD, Schimdt W, Sun CJ, Tripathi SC. Regulatory considerations for preclinical development of anticancer drugs. Cancer Chemother Pharmacol 1998; 41: 173-85.
13. Dayan AD. Testing biotechnology recombinant DNA (rDNA) products. BIRA J 1990; 9: 7-10.
14. Zbinden G. Safety evaluation of biotechnology products. D rug Safety 1990; 5 (Suppl. 1): 58-64.
15. Zbinden G. Predictive value of animal studies in toxicology. Regul Toxicol Pharmacol 1991; 14: 167-77.
16. Bass R, Kleeburg U, Schroder H, et al. Current Guidelines for the Preclinical Safety Assessment of Therapeutic Proteins. Toxicol Letts 1992; 64 / 65: 339-47.
17. Cavagnaro JA. Science-based approach to preclinical safety evaluation of biotechnology products. Pharmaceutl Eng 1992; 12: 32-3.
18. Claude JR. Difficulties in conceiving and applying guidelines for the safety evaluation of biotechnologically-produced drugs: Some examples. Toxicol Letts 1992 ; 64 / 65: 349-55.
19. Terrell TG, Green JD. Issues with biotechnology products in toxicologic pathology. Toxicol Pathol 1994; 22: 187-93.
20. Cavagnaro JA. Preclinical safety assessment of biological products. In Mathieu M, ed. Biologics Development: A Regulatory Overview. Waltham, MA: Parexel International, 1993; 23-40.
21. Sims J. Assessment of biotechnology products for therapeutic use. Toxicol Letts 2001; 120: 59-66.
22. Dayan AD. Safety evaluation of biological and biotechnology-derived medicines. Toxicology 1995; 105: 59-68.
23. Thomas JA. Recent developments and perspectives of biotechnology-derived products . Toxicology 1995; 105: 7-22.
24. Serabian MA, Pilaro AM. Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond. Toxicol Pathol 1999; 27: 27-31.
25. Ryan AM, Terrell TG. Biotechnology and its products. In Handbook of Toxicologic Pathology, 2nd ed. San Diego: Academic Press, 2002; 479-500.
26. Verdier F. Preclinical safety assessment of vaccines in biotechnology and safety assessment. In Thomas JA, Fuchs RL, eds. Biotechnology and Safety Assessment. 3rd ed. Academic Press, San Diego, 2002; 397-412.
27. Brennan FR, Shaw L, Wing MG, Robinson C. Preclinical safety testing of biotechnology - derived pharmaceuticals. Mol Biotechnol 2004; 27: 59-74.
28. Nakazawa T, Kai S, Kawai M, Maki E, Sagami F, Onodera H, Kitajima S, Inoue T. " Points to Consider" regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English Translation). J Toxicol Sci 2004; 29: 497-504.
29. Cavagnaro JA. Predicting safety for novel therapies. Regul Affairs J 2006 ;(June): 1-4.
30. Snodin DJ, Ryle PR. Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals. Biodrugs 2006; 1: 25-52.
31. ICH S5A Detection of Toxicity to Reproduction for Medicinal Products, September 1994.
32. BLAST. http://www.ncbi.nlm.nih.gov/Education/blasttutorial.html.
33. ICH S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals, October 2005. http://www.fda.gov/cder/guidance/index.htm.
34. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers, July 2005.
35. Early Stage Clinical Trial Taskforce, Joint ABPI/BIA Report, July 2, 2006. http://www.abpi.org.uk/information/pdfs/BIAABPI_taskforce2.pdf.
36. Expert Scientific Group on Phase One Clinical Trials, Final Report (" Duff Report "), November 30, 2006. http://www.dh.gov.uk/assetRoot/04/14/10/43/04141043.pdf.
37. Leonard JP, Sherman MT, Fisher GL, Buchanan LJ, Larsen G, Atkins MB, Sosman JA, Dutcher JP, Vogelzang NJ, Ryan JL. Effects of single dose interleukin-12 exposure on interleukin-12 associated toxicity and interleukin-γ production. Blood 1997; 90: 2541-8.
38. ICH S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limited Dose and Related Notes, December 1997 http://www.fda.gov/cder/guidance/index.htm.
39. FDA Challenge and Opportunity on the Critical Path to New Medical Products, March 2004. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.
40. Academy of Medical Sciences Forum Safer Medicines Report. Pre-clinical Toxicology Working Group Report. November 2005.