Drug Development Bibliography

Cancer Drug Development Procedures

1. "Quantitative Comparison of Toxicity of Anticancer Agents in Mouse, Rat, Hamster, Dog, Monkey, and Man" - Emil J. Freireich, Edmund A. Gehan, David P. Rall, Leon H. Schmidt, and Howard E. Skipper. Cancer Chemother. Rep., 50 (4): 219-244, 1966.
2. "Procedures for Preclinical Toxicologic Evaluation of Cancer Chemotherapeutic Agents: Protocols of the Laboratory of Toxicology" - David J. Prieur, David M. Young, Ruth D. Davis, David A. Cooney, Elton R. Homan, Robert L. Dixon, and Anthony M. Guarino. Cancer Chemother. Rep., Part 3, 4 (1): 1-30, 1973.
3. "Relation of Preclinical Toxicology to Findings in Early Clinical Trials" - Charles K. Grieshaber, and Silvia Marsoni. Cancer Treat. Rep., 70 (1): 65-72, 1986.
4. "Potential Roles for Preclinical Pharmacology in Phase I Clinical Trials" - Jerry M. Collins, Daniel S. Zaharko, Robert L. Dedrick, and Bruce A. Chabner. Cancer Treat. Rep., 70 (1): 73-80, 1986.
5. "The Current Toxicology Protocol of the National Cancer Institute" - Michael C. Lowe, Ruth D. Davis. In "Fundamentals of Cancer Chemotherapy," Chapter 24. K. Hellman and S. Carter, eds., New York, McGraw Hill, 1987, 228-235.
6. "Large Animal Toxicological Studies of Anticancer Drugs" - Michael C. Lowe. In "Fundamentals of Cancer Chemotherapy," Chapter 25. K. Hellman and S. Carter, eds., New York, McGraw Hill, 1987, 236-247.
7. "Small Animal Toxicology of Cancer Drugs" - John E. Schuring, William T. Bradner. In "Fundamentals of Cancer Chemotherapy," Chapter 26. K. Hellman and S. Carter, eds., New York, McGraw Hill, 1987, 248-261.
8. "Role of Preclinical Pharmacology in Phase I Clinical Trials: Consideration of Schedule-dependence" - Jerry M. Collins, Brian Leyland-Jones, and Charles K. Grieshaber. In "Concepts, Clinical Developments, and Therapeutic Advances in Cancer Chemotherapy." F.M. Muggia, ed., Martinus Nijhoff Publishers, Boston, 1987, 129-140.
9. "Pharmacologically Guided Phase I Clinical Trials Based upon Preclinical Drug Development" - Jerry M. Collins, Charles K. Grieshaber, and Bruce A. Chabner. J. Nat. Cancer Inst., 82 (16): 1321-26, 1990.
10. "Prediction of Human Toxicity of New Antineoplastic Drugs from Studies in Animals" - Charles K. Grieshaber, In "Mechanisms of Toxicity of Anticancer Drugs: A study in Human Toxicity," G.Powis and M. Hacker, eds., Pergamon Press, New York, 1990, pp. 10-27.
11. "From Test Tube to Patient: New Drug Development in the United States" - U.S. Food & Drug Administration (HFI-40), 5600 Fishers Lane, Rockville, MD. 20857.
12. "Agent-directed Preclinical Toxicology for New Antineoplastic Drugs" - Charles K. Grieshaber, In "Cytotoxic Anticancer Drugs: Models and Concepts for Drug Discovery and Development," F.A. Valeriote and H. Corbett, eds., Kluwer Academic Publishers, Boston, 1992, pp. 247-260.
13. "Toxicology by Organ System" - Michael R. Grever and Charles K. Grieshaber. Chapter XV-8. In Cancer Medicine, 3rd edition. Eds. J. F. Holland, et. al., Lea & Febiger, Philadelphia, 1993, pp. 683-697.
14. "Safety Testing of Antitumor Agents" - Joseph E. Tomaszewski and Adaline C. Smith. Chapter 23. In Comprehensive Toxicology, Toxicity Testing and Evaluation. Eds., P.D. Williams and G.H. Hottendorf, Elsevier Science Ltd, Oxford, England, 1997, vol. 2, pp 299-309.
15. "Regulatory Considerations for Preclinical Development of Anticancer Drugs" - Joseph J. DeGeorge, Chang-Ho Ahn, Paul A. Andrews, Margaret E. Brower, Diana W. Giorgio, M. Anwar Goheer, Doo Y. Lee-Ham, W. David McGuinn, Wendelyn Schmidt, C. Joseph Sun and Satish C. Tripathi. Cancer Chemother. Pharmacol., 41: 173-185, 1998.
16. "Relevance of Preclinical Pharmacology and Toxicology to Phase I Trial Extrapolation Techniques. Relevance of Animal Toxicology." - Joseph E. Tomaszewski, Adaline C. Smith, Joseph M. Covey, Susan J. Donohue, Julie K. Rhie and Karen M. Schweikart. (2001). Chapter 17. In Anti-Cancer Drug Design. Ed., BC Baguley, Academic Press, San Diego, CA, In Preparation.