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Preclinical Development: Overview

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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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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Clinical Trials

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Related Experiment Video

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Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics

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Published on: June 17, 2022

Euro-NOTES Status Paper: from the concept to clinical practice.

K H Fuchs¹, A Meining, D von Renteln

¹Department of Surgery, AGAPLESION-Markus-Krankenhaus, Wilhelm-Epstein-Str. 4, Frankfurt, Germany. Karl-Hermann.Fuchs@fdk.info

Surgical Endoscopy

|April 2, 2013

Summary

This summary is machine-generated.

Natural orifice transluminal endoscopic surgery (NOTES) reduces trauma and improves recovery. Hybrid approaches overcome limitations, with established transvaginal, transgastric, and transanal routes for various procedures.

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Area of Science:

Minimally invasive surgery
Gastroenterology
Surgical innovation

Background:

Natural Orifice Transluminal Endoscopic Surgery (NOTES) aims to reduce surgical trauma by accessing the abdominal cavity through natural orifices.
Potential benefits include reduced postoperative pain, faster recovery, and fewer complications compared to traditional surgery.
The Euro-NOTES Foundation has been instrumental in advancing NOTES research and clinical practice.

Framework:

Analysis of Euro-NOTES and D-NOTES working group reports from 2007-2011.
Focus on key topics: infection, peritoneal access, training, technology, and closure techniques.
Evolution of research priorities and insights over time.

Implementation:

Hybrid NOTES approaches have addressed technical and safety challenges of pure NOTES.
Established NOTES access routes include transvaginal (cholecystectomy, appendectomy, colon resection), transesophageal (myotomy), transgastric (tumor resection), and transanal/transcolonic (rectal/colon resection).

Implications:

NOTES and hybrid techniques are now in clinical practice with a favorable safety profile.
Specific natural orifices are suited for different indications, requiring optimized techniques.
These advancements offer safe and realistic surgical solutions tailored to patient needs.