Abstract
The challenge of drug discovery and drug development to the pharmaceutical toxicologist is that a drug is supposed to have a biological function and requires a scientific understanding of mechanistically based toxicity. Furthermore, drug development allows the toxicologist become somewhat flexible in developing the toxicology program that allows the entry into early stage clinical trials.
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References
Berliner, VR. (1974) US Food and Drug Administration requirements for toxicity testing of contraceptive products. In: Briggs MH, Diczbalusy E, eds. Pharmacological models in contraceptive development. Acta Endocrinol (Copenhagen) supp. 185; 240–253.
Burns, J. (1983) Overview of safety regulations governing food, drug and cosmetics. In: Homberger F, Ed., The United States in safety and evaluation and regulation of chemicals 3: interface between law and science. New York: Karger, 1983.
DeGeorge, J., Ahn, C., Andrews, P., Bower, M., Giorgio, D., Goheer, M., Lee-Yam, D., McGuinn, W., Schmidt, W., Sun, C., and Tripathi, S. (1998) Regulatory Considerations for the Preclinical Development of Anticancer Drugs. Cancer Chemother. Pharmacol. 41, 173–185.
Gad, S.C. (2009) Drug Safety Evaluation, 2nd ED. New York: Wiley-Interscience.
Goldenthal, E. (1968) Current view on safety evaluation of drugs. FDA Papers, 13–18.
Hastings, K.L. (2007) Nonclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. FDA www.fda.gov.
Hood, R.D. (2006) Developmental and Reproductive Toxicology: a practical approach, 2nd ED. Taylor & Francis, Philadelphia.
ICH (2001) International Conference on Harmonization: Safety Pharmacology Studies for Human Pharmaceuticals, S7A.
ICH (2008) M3 (R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
Mathieu, M. (2005) New drug development: A regulatory overview. 7th edition. Parexel, Waltham, MA.
Schacter, E. and DeSantis, P. (1998) Labeling of Drug and Biologic Products for Pediatric Use. Drug Information Journal 32, 299–303.
Swidersky, P. (2007). Quality assurance and good lab practice. Contract Pharma. www.contractpharma.com.
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Gad, S.C. (2011). IND-Enabling Toxicology Programs. In: Safety Evaluation of Pharmaceuticals and Medical Devices. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-7449-5_3
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DOI: https://doi.org/10.1007/978-1-4419-7449-5_3
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