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Clinical Pharmacology and Therapeutics

The mission of the Department of Clinical Pharmacology and Therapeutics of Seoul National University Hospital (SNUCPT) is "As one of the world's leading groups for innovative research, education/training, and clinical pharmacology practice, will maximize the effectiveness of medicines by creating, applying and promoting integrated information and knowledge for personalized optimal pharmacotherapy. These efforts will contribute to a healthier and happier life for people around the world.". Based on the mission, the department conducts various research, education, treatment, and treatment support activities on clinical pharmacology, clinical trials, and optimal pharmacotherapy.

In June 1988, SNUCPT started as a Clinical Pharmacology Task Force under the Board of Pharmacy Affairs and organized as an official institution of the Supporting Services which is 'Clinical Pharmacology Unit' in June 1994. As a major member of the Clinical Trials Center, established in 1996, it has been gradually expanding its role. Conducting not only pharmacotherapeutic consultations regarding therapeutic drug monitoring (TDM) but also, early phase clinical trials, consultation of new drug clinical development and clinical drug research, pharmacokinetic /pharmacodynamic analysis, clinical trial simulation, and clinical trials expert training. In addition, it was designated as a Regional Clinical Trial Center by Ministry of Health and Welfare. In December 2007, the unit grew to 'Department of Clinical Pharmacology and Therapeutics' since the role of a clinical pharmacologist, the expert of clinical trials and personalized optimal pharmacotherapy, has been increased in the hospital. Moreover, the College of Medicine established 'Department of Clinical Pharmacology and Therapeutics' in March 2012.

Currently, more than 40 clinical projects related to personalized optimal pharmacotherapy are carried out each year independently or in collaboration with other departments, and approximately 10,000 cases of TDM consultation and 700 cases of consultation of personalized optimal pharmacotherapy are conducted each year. The SNUCPT’s clinical activities are focused on translational research and practice and encompasses the fields of basic medical science (clinical pharmacokinetics, pharmacodynamics, genetics, pharmacology and biochemistry, biostatistics, analytical chemistry, pharmacogenomics, metabolomics, etc.) and clinical medical science (clinical application of personalized optimal pharmacotherapy). Specifically, the members of SNUCPT performs consultation on personalized optimal pharmacotherapy based on various patient characteristics such as pharmacokinetics, pharmacodynamics, disease status, drug interaction, genetic diversity. Also, the members of SNUCPT are generating evidences for those clinical activities by various research activities (e.g., clinical trials, pharmacokinetics/pharmacodynamics modeling and simulation). In addition, SNUCPT has built a foundation for new drug development and personalized pharmacotherapy by training and educating professional experts in drug clinical development and pharmacotherapy field through the clinical pharmacology specialist training program.

Clinical Trial
In cooperation with the Clinical Trial Center of Seoul National University Hospital, SNUCPT conducts various Academic Research Organization activities (e.g., study design, study conduct, statistical analysis, medical writing, clinical development consulting) for new drug development and for optimal pharmacotherapy. SNUCPT leads the field of the early-phase clinical trial in Korea by conducting numbers of early phase clinical trials on new drug development and by consulting general clinical development process of domestic and multinational pharmaceutical companies.

Pharmacotherapy Consultation
SNUCPT provides a various pharmacotherapeutic consultation for optimal pharmacotherapy, and the areas of consultation includes therapeutic drug monitoring, analysis of specific drug concentration, population pharmacokinetics/pharmacodynamics modeling and simulation, method development for therapeutic drug monitoring of new drugs, management of drug interaction, management of adverse events, adjustment of dosage and regimen, pharmacogenetics and providing recent drug information.

For example, SNUCPT has been performing TDM activities of voriconazole in invasive fungal infection patients and TDM activities of busulfan in chronic myeloid leukemia patients. In addition, SNUCPT provides integrated information about the safety and efficacy of drug based on pharmacogenomic and pharmacometabolomic studies and develops dosing algorithms for the application of optimal pharmacotherapy.

TDM refers to a series of clinical activities that provide feedback while continuously monitoring drug response for the optimal pharmacotherapy of each patient. In a narrow sense, it is mainly used as monitoring the plasma drug concentration to maintain effective plasma concentration ranges to maximize the personalized therapeutic effect of each patient while minimizing adverse drug reactions. The frequently monitored drugs include antibiotics, antiepileptic drugs, and cardiac stimulants with a well-known therapeutic window. TDM enables optimal pharmacotherapy with consideration of pharmacokinetic variability by adjusting the dose regimen based on the drug concentration data. The TDM for individual patients become generalized in many hospitals and its need for newly developed therapeutics are increasing, owing to the with recent advancement in analytical chemistry and clinical pharmacokinetics.

Adverse Drug Reaction consultation
SNUCPT participates in monitoring and management of adverse drug reactions in cooperation with the Drug Safety Center. Particularly, SNUCPT performs active surveillance and management of adverse drug reaction observed during therapeutic drug monitoring and finds signals of adverse drug reaction from big data such as electronic medical records and claim data of National Health Insurance Corporation. Through the activities, SNUCPT contribute to providing information for safer use of drug for patients.

Education programs
SNUCPT provides education programs to perform effective pharmacotherapy, personalized optimal pharmacotherapy by combining pharmacological concepts into clinical medicine through systematic education programs. SNUCPT has been training creative and future-oriented professionals who will lead 21st-century medical science in terms of translational medicine who understands and utilizes advanced basic and applied sciences.

A. Clinical pharmacology specialist training
Clinical pharmacology specialist training systems have been established relatively recently in Korea. Seoul National University Hospital has been running a clinical pharmacology specialists training program for medical doctors since 1998. The trainees improve their abilities to apply personalized pharmacotherapy to patient care by acquiring knowledge of overall clinical pharmacology. Also, they develop abilities to conduct the medical research by understanding clinical pharmacological research methods on the causes of the variability of drug response. Since 2007, SNUCPT recruited 2 trainees each year, and from 2011, 3 trainees have been recruited. The main details of the training are listed as follows:

      - Clinical Pharmacokinetics/pharmacodynamics, Modeling & Simulation
- Clinical trials in drug development (Design, conduct, consulting and data analysis)
      - Therapeutic drug monitoring (TDM) and optimal pharmacotherapy
      - Pharmacogenomics, Pharmacometabolomics
      - Drug-drug interaction
      - Pharmacotherapy in special population (renal impairment, hepatic impairment, geriatrics, pediatrics, etc.)
      - Adverse drug reaction (ADR), Drug addiction

B. Education program for undergraduate students
SNUCPT provides lectures on 'basic pharmacology for the first-year students of the undergraduate course in the Seoul National University College of Medicine, and supports hands-on practices such as drug selection and prescription (P-drug workshop). SNUCPT also in charge of the 'clinical pharmacology' lecture for the fourth-year students of undergraduate courses and it has been provided clinical pharmacology training education as an elective clinical clerkship since 2013. SNUCPT also participates ‘Medical Research 2’ program and provides an opportunity for second-year undergraduate students to learn about the clinical and research works performed in the SNUCPT. During summer and winter vacations, we are running internship programs for the students studying medicine, pharmacy, and other majors to experience clinical pharmacology. Also, SNUCPT is actively involved in clinical pharmacology education for the staffs of Seoul National University Hospital.

      - Inter-individual variability of drug response, pharmacogenomics
      - New drug development and clinical trials
      - Optimal pharmacotherapy and concepts of PK/PD
      - Therapeutic drug monitoring
      - Drug-drug interaction
      - Adverse events 
      - Study protocol and Informed consent for clinical trial, IRB
      - Appropriate drug dose and regimen in the special population 
      - Drug regulation 
      - Drug information

C. Graduate course
SNUCPT aims to educate masters and doctors of philosophy who can apply clinical pharmacological methods to patient treatment and clinical research. Using the clinical pharmacology methodologies 

Through the graduate course, the students perform various researches using the clinical pharmacology methodologies and the research topics includes pharmacogenomics, pharmacometabolomics, pharmacokinetic-pharmacodynamics modeling, and simulation. The students develop ability to improve their medical knowledge and disseminate it to others from the graduate course.

The main educational topics are listed as follows:
      - Pharmaceutical Medicine
      - Adverse Drug Reactions and Hypersensitivity
      - Clinical Aspects of Drug Interaction
      - Regulatory Aspects related to New Drug Development
      - Clinical Pharmacodynamics and Evaluation Methods
      - Optimal Therapy in Special Patients
      - Clinical Pharmacogenetics
      - Advanced Methods in PK/PK modeling
      - Molecular Pharmacogenetics
      - Seminar in Clinical Trials

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