Abstract
In the pharmaceutical development arena, Drucker’s quotation represents one of the biggest challenges to be faced. One can set up many great plans and strategies, but until they are set in motion they remain abstract. Planning is one of the key steps for efficiently leading a project to a successful completion and its importance has long been recognized in many disciplines besides pharmaceutical development. Although the plan itself does not constitute a guarantee for a successful outcome, it maximizes the chances of success while attempting to minimize unexpected and unnecessary detours. Success in the pharmaceutical development process is often measured by the ability of a company to discover compounds with promising therapeutic effects and, through efficient testing in animals and humans, learn enough about their properties so they can be used in a manner such that the observed benefits outweigh the potential risks to the patient. From a business perspective, with efficiency being the key to survival, success is most often measured by the company’s ability to reach its destination in the most expeditious manner while using the fewest resources and without compromising the quality of the essential information gathered along the process.
Plans are only good intentions unless they immediately degenerate into hard work.
— Peter F. Drucker
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References
Guidance for Industry: ICH M3 Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, November, 2000.
Guidance for Industry: ICH S6 Preclinical Evaluation of Biotechnology-Derived Pharmaceuticals, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, July, 1997.
United States Good Laboratory Practices Regulation. Title 21 of the Code of Federal Regulations, Part 58 (21 CFR part 58).
Derelanko MJ, Hollinger MA. Handbook of Toxicology, 2nd ed. New York: CRC Press. 2001.
Hull RM. Guidelines limit volumes for dosing animals in the preclinical stage of safety evaluation. Hum Exp Toxicol 1995; 14: 305–307.
Diehl KH, Hull R, Morton D, et al. A good practice guide to the administration of substances and removal of blood, including routes and volumes. JAppl Toxicol 2001; 21: 15–23.
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© 2004 Humana Press Inc., Totowa, NJ
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Roy, D., Andrews, P.A. (2004). Nonclinical Testing. In: Teicher, B.A., Andrews, P.A. (eds) Anticancer Drug Development Guide. Cancer Drug Discovery and Development. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-739-0_13
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DOI: https://doi.org/10.1007/978-1-59259-739-0_13
Publisher Name: Humana Press, Totowa, NJ
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