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Preclinical Development: Overview

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Related Experiment Video

Updated: Dec 6, 2025

Longitudinal In Vivo Imaging and Quantification of Human Pancreatic Islet Grafting and Contributing Host Cells in the Anterior Eye Chamber

Longitudinal In Vivo Imaging and Quantification of Human Pancreatic Islet Grafting and Contributing Host Cells in the Anterior Eye Chamber

Published on: June 11, 2020

Beta Cell Imaging-From Pre-Clinical Validation to First in Man Testing.

Stephane Demine¹, Michael L Schulte², Paul R Territo^2,3

¹Indiana Biosciences Research Institute, Indianapolis, IN 46202, USA.

International Journal of Molecular Sciences

|October 6, 2020

Summary

Quantifying human pancreatic beta cell mass (BCM) in vivo is crucial for diabetes research and treatment. New biomarkers like DPP6 and FXYD2ga show promise for BCM imaging and personalized therapies.

Keywords:

MRI PET SPECT beta cell imaging pancreas pre-clinical validation radiochemistry type 1 diabetes type 2 diabetes

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Last Updated: Dec 6, 2025

Longitudinal In Vivo Imaging and Quantification of Human Pancreatic Islet Grafting and Contributing Host Cells in the Anterior Eye Chamber

Longitudinal In Vivo Imaging and Quantification of Human Pancreatic Islet Grafting and Contributing Host Cells in the Anterior Eye Chamber

Published on: June 11, 2020

A High-content In Vitro Pancreatic Islet β-cell Replication Discovery Platform

A High-content In Vitro Pancreatic Islet β-cell Replication Discovery Platform

Published on: July 16, 2016

Author Spotlight: Investigating Islet Abnormalities and Function with a Pseudoislet Protocol

Author Spotlight: Investigating Islet Abnormalities and Function with a Pseudoislet Protocol

Published on: November 3, 2023

Area of Science:

Endocrinology
Medical Imaging
Molecular Biology

Background:

Accurate quantification of human pancreatic beta cell mass (BCM) in vivo is currently unavailable.
This limitation hinders understanding of diabetes progression and the efficacy of islet transplantation.
The absence of beta cell imaging impedes the assessment of novel diabetes drugs targeting BCM.

Purpose of the Study:

To highlight the significance of BCM determination for personalized diabetes therapies.
To review existing probes for human BCM evaluation.
To introduce a novel approach for discovering beta cell biomarkers using splice variants.

Main Methods:

Investigated specific splice variants in human beta cells to identify novel biomarkers.
Evaluated DPP6 and FXYD2ga as potential targets for human BCM imaging.
Discussed radiochemistry's role in advancing BCM imaging techniques.

Main Results:

Identified DPP6 and FXYD2ga as promising targets for human BCM imaging.
Explored the potential of splice variants for beta cell biomarker discovery.
Outlined the pathway from pre-clinical validation to human trials for new tracers.

Conclusions:

Developing reliable in vivo methods for BCM quantification is essential for diabetes management.
Novel biomarkers derived from splice variants offer new avenues for beta cell imaging.
Advancements in radiochemistry and biomarker discovery pave the way for improved BCM imaging and personalized diabetes treatments.