SNUCPT

Department of Clinical Pharmacology and Therapeutics of Seoul National University Hospital (SNUCPT) designs, performs and assesses clinical researches of early phase and bridging study exploring inter-ethnic susceptibility. These clinical researches are conducted scientifically and ethically at the Seoul National University Hospital Clinical Trial Center in accordance with international guidelines including Korea Good Clinical Practice (KGCP), International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) guidelines. Our center provides the most optimal research environment.

Definition of clinical research

• Clinical research refers to studies or trials that are conducted on a person to confirm the pharmacokinetics, pharmacodynamics, pharmacological and clinical effects of the drug and to investigate the adverse events for the purpose of demonstrating the safety and efficacy of the investigational product (new drug).
• - Classification based on the objective of clinical research: Human pharmacology research, Therapeutic exploratory research, Therapeutic confirmatory research, Therapeutic use research
• - Classification based on stages of clinical research: Phase 1, Phase 2, Phase 3, Phase 4

Classification of clinical research

• Classification based on the objective of clinical research

Classification of clinical research	Objective of study	Study examples
Human pharmacology	- Assess tolerability - Define/describe PK and PD - Explore drug metabolism and drug interactions - Estimate activity	- Dose-tolerability studies - Single and multiple dose PK and/or PD studies - Drug interaction studies
Therapeutic exploratory	- Explore use of the targeted indication - Estimate dosage for subsequent studies - Provide basis for confirmatory study design, endpoints, methodologies	- Earliest trials of relatively short duration in well-defined narrow patient populations, using surrogate of pharmacological endpoints or clinical measures - Dose-response exploration studies
Therapeutic confirmatory	- Demonstrate/confirm efficacy - Establish safety profile - Provide an adequate basis for assessing the benefit/risk relationship to support licensing - Establish dose-response relationship	- Adequate, and well controlled studies to establish efficacy - Randomized parallel dose response studies - Clinical safety studies - Studies of mortality/morbidity outcomes - Large simple trials - Comparative studies
Therapeutic use	- Refine understanding of benefit/risk relationship in general or special populations and/or environments - Identify less common adverse reactions - Refine dosing recommendation	- Comparative effectiveness studies - Studies of mortality/morbidity outcomes - Studies of additional endpoints - Large simple trials - Pharmacoeconomic studies

• Classification based on the stage of clinical research

• To discover potential candidates for new drug development
• Preclinical study
• Phase 1 clinical trial
• Phase 2 clinical trial
• Phase 3 clinical trial
• New drug approvals
• Phase 4 clinical trial (post marketing surveillance study)

Examples of clinical pharmacology research

• First-in human (FIH) study

- Clinical researches that first apply new drug candidates to the human body

- As exploratory clinical researches, FIH study evaluates safety, tolerability, pharmacokinetics and pharmacodynamics properties of new drug candidates.

• Drug-drug interaction study

- Evaluate the possibility of interaction between drugs and other intrinsic/extrinsic factors (comedication, food, genome, etc.)

- Drug-drug interaction, Drug-food interaction, Drug-gene interaction study, etc.

• Comparative pharmacokinetic/pharmacodynamic study

- Bioavailability study: Compare the bioavailability of the formulation to be absorbed by the systemic circulation when the formulation is completely absorbed (such as intravenous injection) orally.

- Comparative study of pharmacokinetic and pharmacodynamic studies on incrementally modified drugs and approved drugs

• Bioequivalence study

- To evaluate whether two agents containing the same active ingredient in the same route of administration are statistically equivalent in bioavailability

• Special population study

- To explore appropriate drug dose and regimen in the special population

- Clinical researches for renal impairment patients, hepatic impairment patients, pediatrics, geriatrics, etc.

• Multi-ethnic study

- Evaluate differences in genetic variants frequency for drug metabolism enzyme/transporters expression between different ethnic groups

- Evaluate pharmacokinetic/pharmacodynamic similarities and differences of certain drugs between different ethnic groups

- Bridging study: Explore whether clinical research data from other ethnicity are applicable in Koreans

• Pharmacokinetic/Pharmacodynamic study

- Explore the relationship between serum drug concentration and pharmacodynamic indicators (EEG, gastric pH, bio-imaging(PET/MRI), etc.)

• Others

- Microdose study: A preliminary study to obtain initial information about the application of the drug candidate to a small number of subjects at a low dose (less than 1/100 of the usual therapeutic dose)

- QT/QTc study: Evaluate the effect of the new drug candidate on QT/QTc (Corrected QT) interval to assess the risk of arrhythmia