Related Experiment Video
Updated: May 7, 2026
07:45
Preclinical Positron Emission Tomography with Body Conforming Animal Molds for Cloud-Based Automated Image Analysis in Mice
Published on: October 25, 2024
Safety biomarkers in preclinical development: translational potential
V G Sasseville1, K G Mansfield, D J Brees
1Discovery and Investigative Safety, Preclinical Safety, Novartis Institutes for Biomedical Research, Cambridge, MA 02139, USA.
Veterinary Pathology
|October 5, 2013
Summary
Developing translational safety biomarkers is crucial for drug discovery. These minimally invasive biomarkers help assess human toxicity relevance during clinical trials, aiding risk-adverse drug development.
Area of Science:
- Biomarker Discovery
- Drug Development
- Toxicology
Background:
- Safety biomarkers are vital for drug discovery and development, especially for novel targets and indications.
- Minimally invasive translational safety biomarkers are needed to assess human relevance of drug-induced toxicities observed in preclinical studies.
- Biomarker qualification requires careful analysis of analytical methods, biological properties, pharmacokinetics, pharmacodynamics, and disease pathophysiology.
Purpose of the Study:
- To review technologies used in developing fluid- and tissue-based safety biomarkers.
- To highlight novel assay development in safety biomarker research.
Main Methods:
- Review of existing literature and technologies for safety biomarker development.
- Analysis of commonly employed methods in fluid- and tissue-based biomarker research.
Main Results:
- Commonly employed technologies in safety biomarker development are summarized.
- Areas of novel assay development are identified.
Conclusions:
- Effective safety biomarker development and qualification are essential for successful and risk-adverse drug discovery.
- Advancements in assay technologies are crucial for identifying reliable translational safety biomarkers.
Related Concept Videos
01:28Preclinical 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...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:23Toxicity Testing in Animals
Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
02:43Mouse Models of Cancer Study
Mice have long served as models for studying human biology and pathology because of their phylogenetic and physiological similarity with humans. They are also easy to maintain and breed in the laboratory, and hence, many inbred strains are now available for research. Studies on mice have contributed immeasurably to our understanding of cancer biology.
The development of transgenic, knockout, and knock-in mice has led to an exponential increase in their use as model organisms in research,...
The development of transgenic, knockout, and knock-in mice has led to an exponential increase in their use as model organisms in research,...