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What is not a part of in vivo pre-clinical research?

-Determine whether the drug causes chromosomal damage in a cancer-prone mouse model
-Determine possible changes in the levels of liver enzymes
-Determine how the test article affects heart physiology in mice
-Evaluate changes in certain biomarkers that would indicate that the drug is active
-Developing a colorimetric bioassay to assess ability of a drug to inhibit a protein's activity

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Final answer:

Developing a colorimetric bioassay to assess the ability of a drug to inhibit a protein's activity is not part of in vivo pre-clinical research; it is an in vitro method used to study drug-protein interactions at a molecular level before advancing to animal models.

Step-by-step explanation:

In the context of in vivo pre-clinical research, the activities listed pertain to the evaluation of drug properties using animal models such as mice or rats. These include determining chromosomal damage in cancer-prone models, assessing changes in liver enzymes, affecting heart physiology, and evaluating biomarkers for drug activity. However, the development of a colorimetric bioassay to assess the inhibition of a protein's activity is typically an in vitro method. While both in vivo and in vitro methods are crucial in drug development, a colorimetric bioassay is an in vitro technique not part of the in vivo aspect of pre-clinical research.

In vivo studies provide crucial information on pharmacokinetics, including the drug's absorption, distribution, clearance, and exposure. In vivo pharmacokinetic studies greatly assist in the lead characterization and are complemented by in vitro techniques. However, the design and development of bioassays, such as a colorimetric assay for protein inhibition, are generally conducted in vitro to understand drug interactions at a molecular level before proceeding to in vivo studies.

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