Abstract
Pharmacometrics is the science of quantifying disease, drug, and trial characteristics with the goal of influencing drug development and regulatory and therapeutic decisions. Techniques employing pharmacometric principles are increasingly being used, allowing for efficient utilization of prior experimental information and ultimately streamlining drug development. Using mathematical and statistical models, modeling and simulation allows a simplification of complex systems under investigation and may be able to predict the effects of various treatment options, and the corresponding consequence, on the future course of the disease process. The summation of information can be used to develop more efficient, and hopefully successful, clinical trials. This chapter summarizes the basic theory and application of pharmacometric techniques. Examples of where such pharmacometric principles have been successfully employed in oncology drug development are presented.
The chapter was written while the corresponding author (Joga Gobburu) was at the FDA.
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Brar, S.S., Gobburu, J. (2014). Pharmacometrics. In: Rudek, M., Chau, C., Figg, W., McLeod, H. (eds) Handbook of Anticancer Pharmacokinetics and Pharmacodynamics. Cancer Drug Discovery and Development. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9135-4_11
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