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TR stages

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Demet G. Sag
Demet G. Sag

This document discusses translational research terminology and clarifies common misconceptions. It defines the 5 stages of translational research from preclinical animal studies to post-marketing regulatory studies. Additionally, it explains the objectives of clinical trials and distinguishes between pharmacokinetics, which describes what the body does to a drug, and pharmacodynamics, which describes what a drug does to the body.

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TR stages
• • There is a misconception about "Translational Research" terminology. I realized that terms used interchangeably but incorrectly as I was sharing my experience with people about my next opportunity.
Translational Research (TR) from bench to bedside • Translational Research 0 (TR0): Wet lab-bench work, drug discovery and Animal Studies (PRECLINICAL STUDY- Early Development) • TR1: First in Human Studies (Phase 1) and Proof of concept Study (Phase2), Even though they are in human but not proven to be use to in human • TR2: Phase 3, example Drug Efficacy during development of a drug • TR3: Regulatory Studies required by regulatory bodies like FDA. The results from the Phase 3 studies used. • TR4: Phase 4, Surveillance-Post-marketing Studies
Technology Transfer to Improve Human Health Novel technologies potential to improve human health integrating scientific development technologies and conducting clinical studies. * Development phases classified in 5 technologies: 1- Drug 2- Medical Device 3- Biologics 4- Biomarker Analysis Assays 5- Imaging Procedures
What is PK and PD: How do they relate to each other? Pharmakokinetics (PK): • What the human body does to the body Pharmacodynamics (PD): • What a drug does to the human body
Objectives of a Clinical Trial We may have 3 Types of Clinical Trial Objectives: 1. Ideal Health/ Primordial Intervention/Healthy 2. Primary Prevention/ Risk Factors/Acute 3. Secondary Prevention/ Disease to treat disease/Chronic

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TR stages

  • 2. • • There is a misconception about "Translational Research" terminology. I realized that terms used interchangeably but incorrectly as I was sharing my experience with people about my next opportunity.
  • 3. Translational Research (TR) from bench to bedside • Translational Research 0 (TR0): Wet lab-bench work, drug discovery and Animal Studies (PRECLINICAL STUDY- Early Development) • TR1: First in Human Studies (Phase 1) and Proof of concept Study (Phase2), Even though they are in human but not proven to be use to in human • TR2: Phase 3, example Drug Efficacy during development of a drug • TR3: Regulatory Studies required by regulatory bodies like FDA. The results from the Phase 3 studies used. • TR4: Phase 4, Surveillance-Post-marketing Studies
  • 4. Technology Transfer to Improve Human Health Novel technologies potential to improve human health integrating scientific development technologies and conducting clinical studies. * Development phases classified in 5 technologies: 1- Drug 2- Medical Device 3- Biologics 4- Biomarker Analysis Assays 5- Imaging Procedures
  • 5. What is PK and PD: How do they relate to each other? Pharmakokinetics (PK): • What the human body does to the body Pharmacodynamics (PD): • What a drug does to the human body
  • 6. Objectives of a Clinical Trial We may have 3 Types of Clinical Trial Objectives: 1. Ideal Health/ Primordial Intervention/Healthy 2. Primary Prevention/ Risk Factors/Acute 3. Secondary Prevention/ Disease to treat disease/Chronic