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•
• 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

  • 1.
  • 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