Toxicokinetic protocols

Protocols for these studies are similar to those for studies of shorter duration, except that a minimum of 15 to 20 rodents per group and 4 nonrodents per sex per group are required. All of the previously described in-life and postmortem studies are required. Toxicokinetic measurements are required at time points up to and including the termination of the study. 

An appendix is included that provides examples of four current toxicokinetic study protocols for chemicals scheduled for toxicological evaluation using oral (gavage and feed), topical, and inhalation routes. 

TOXICOKINETICS STUDY PROTOCOL FOR METHYLENE BLUE (AN ORAL STUDY USING INTRAGASTRIC DOSING)... 

TOXICOKINETICS STUDIES PROTOCOL FOR DECALIN/FETRALIN (AN INHALATION EXPOSURE)... 

When a macromolecule moves into development, early toxicokinetic (TK) protocols (e.g., dose range finding) and ADME studies will require bioanalytical assay support. At this time, better characterized reference standard should be available, along with more mature critical reagents. The assay developer continues to gain knowledge of the assay performance by continuing characterization studies and... 

As we will see later in this chapter, not only is one able to alter a nanostructure by the types of atoms and their stoichiometries, but also their 3-D arrangement. With such profound nanostmctural variety, it is no wonder that standardized toxicokinetics studies i.e., absorption, distribution, metabolism, and excretion characteristics) are still greatly lacking. For this to occur, there is a need for reference nanomaterials that would allow a systematic structure V5. toxicity assessment for various classes of nanostructures. To date, the only commercially-available reference materials are spherical nanoparticles that are used to calibrate particle-size analyzers. Such reference materials will only be possible once we have standardized protocols for the synthesis and characterization of various types of nanomaterials, an active area of investigati(Mi at the National Institute of Standards and Technology (NIST). 

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