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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: Jul 29, 2025

Preclinical Model of Prenatal Delta-9-Tetrahydrocannabinol Exposure to Assess Its Impact on Neurodevelopmental Outcomes

Preclinical Model of Prenatal Delta-9-Tetrahydrocannabinol Exposure to Assess Its Impact on Neurodevelopmental Outcomes

Published on: February 28, 2025

Guidelines to Analyze Preclinical Studies Using Perinatal Derivatives.

Ana Salomé Pires^1,2,3, Sveva Bollini⁴, Maria Filomena Botelho^1,2,3

¹Coimbra Institute for Clinical and Biomedical Research (iCBR) Area of Environment, Genetics and Oncobiology (CIMAGO), Institute of Biophysics, Faculty of Medicine, University of Coimbra, 3000-548 Coimbra, Portugal.

Methods and Protocols

|May 23, 2023

Summary

This summary is machine-generated.

Perinatal derivatives (PnD) show therapeutic promise. This study outlines methods to systematically review preclinical data, standardizing PnD nomenclature for efficacy assessment and promoting ethical animal research.

Keywords:

animal models consensus database search perinatal derivatives preclinical studies protocol

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Area of Science:

Regenerative Medicine
Translational Research
Biomedical Science

Background:

Growing interest in perinatal derivatives (PnD) for therapeutic applications over the past 18 years.
Preclinical studies assessing PnD therapy utilize diverse study designs.
The COST SPRINT Action (CA17116) focuses on PnD's therapeutic potential and mechanisms.

Purpose of the Study:

To systematically review preclinical studies on PnD therapy efficacy and mechanisms.
To establish data collection and synthesis strategies for meta-analyses and reviews.
To harmonize PnD nomenclature for standardized treatment assessment.

Main Methods:

Publication search, data mining, extraction, and synthesis strategies were employed.
Data preparation focused on treatment efficacy, administration parameters, and dosage.
Harmonization of PnD nomenclature according to proposed guidelines.

Main Results:

Strategies were developed to prepare data for meta-analyses and reviews on PnD efficacy.
The data preparation enables statements on treatment efficacy across various PnD types, routes, and dosages.
Standardized data will support assessment of PnD treatments in different disease models.

Conclusions:

Systematic data preparation is crucial for understanding PnD therapeutic potential.
Harmonized nomenclature and data standards will advance PnD research and clinical translation.
The initiative aims to establish standards for PnD safety and efficacy, aligning with the 3Rs principles for animal research.