Designing an In Vivo Efficacy Study of Nanomedicines for Preclinical Tumor Growth Inhibition
Novel nanoformulated chemotherapeutics and diagnostics require demonstration of efficacy and safety in appropriate animal models prior to conducting early-phase clinical trials. In vivo efficacy experiments are tailored to the tumor model type and route of administration as well as several parameters related to the nanoformulation, like drug loading to determine dosing volume. When designing in vivo efficacy studies for nanomedicines, understanding the relationship between tumor biology and the nanoformulation characteristics is critical to achieving meaningful results, along with applying appropriate drug and nanoformulation controls. In particular, nanoparticles can have multifunctional roles such as targeting and imaging capabilities that require additional considerations when designing in vivo efficacy studies and choosing tumor models. In this chapter, we outline a general study design for a subcutaneously implanted tumor model along with an example of tumor growth inhibition and survival analysis.
Key wordsNanoformulation Tumor model Subcutaneous Statistical analysis Biology
Frederick National Laboratory is accredited by AAALAC International and follows the Public Health Service Policy for the Care and Use of Laboratory Animals (Health Research Extension Act of 1985, Public Law 99-158, 1986). Animal care is provided in accordance with the procedures outlined in the “Guide for Care and Use of Laboratory Animals” (National Research Council, 1996; National Academy Press, Washington, D.C.). All animal protocols are approved by the FNL Institutional Animal Care and Use Committee (IACUC). Any experiments performed are scientifically justified and are not an unnecessary duplication of previous work by others.
This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
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