The mission of the Department of Clinical Pharmacology and Therapeutics of Seoul National University Hospital (SNUCPT) is "As one of the world's leading centers 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, SNUCPT is performing a wide range of clinical research and education of 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 at 1996, it has been gradually expanding its role. Conducting not only pharmacotherapeutic consultations regarding therapeutic drug monitoring but also, early clinical trials, new drug clinical development, consultation of clinical drug research, pharmacokinetic/ pharmacodynamic analysis, clinical trial simulation, and clinical trials expert training. In addition, it was appointed 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 30 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 therapeutic drug monitoring (TDM) consultation and 700 cases of consultation of personalized pharmacotherapy are conducted each year. Clinical pharmacology is an area of translational research & practice which includes basic medicine such as clinical pharmacokinetics/pharmacodynamics, genetics, pharmacology, biochemistry, biostatistics and analytical chemistry, and clinical medicine such as omics methodologies; pharmacogenomics and metabolomics and so on. Research focused on pharmacokinetic, pharmacodynamic clinical assessments and the differences of drug response by genetic diversity are conducted. Moreover, it includes a wide range of the development process for the drug information and applies to patients through clinical trials and TDM consultation. Also clinical trial and personalized therapy research are being conducted through pharmacokinetic /pharmacodynamics modelling and simulation. 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.
By correlating with Seoul National University Hospital Clinical Trials Center, SNUCPT has played a pivotal role in new drug development by providing consultations and conducting clinical trials. SNUCPT is leading the field of early phase clinical trial by performing most of the clinical trials of domestic new drug. Moreover, SNUCPT performs early phase clinical trial and consults clinical development process of not only domestic pharmaceutical companies but also multinational pharmaceutical enterprises.
The Department of Clinical Pharmacology and Therapeutics conducts various personalized pharmacotherapy consults which includes therapeutic drug monitoring (TDM), population pharmacokinetic analysis, development of new drug TDM and pharmacokinetic analysis method, drug interactions, adverse drug reactions, dosage adjustments, pharmacogenetics, and drug Information.
Research and consultations has been conducted for the establishment of genetic polymorphism of CYP2C19 and voriconazole optimal therapeutic dosage, and determination of busulfan therapeutic range in chronic myeloid leukemia (CML) patients. Recently, additional therapeutic drug monitoring of tacrolimus for patients undergone renal transplantation has been made available. Also, SNUCPT provides information of drug efficacy and side effects by pharmacogenomics and metabolomics and develops algorithms of dosage which are applied in clinical practice and optimal pharmacotherapy.
TDM means a series of activities that provide feedback of appropriate drug therapy for individual patients by observing drug responses consistently. TDM is used to maximize the efficacy of personal pharmacotherapy. By monitoring the blood level of specific drugs at timed intervals, the effective concentration is maintained and at the same time the risk of toxicity is minimized. Currently, several antibiotics (vancomycin, amikacin, etc.), antiepileptic drugs (valproate, phenytoin, etc.) and cardiac stimulants which have well-known therapeutic range are in service and about 10,000 cases are consulted every year. Therapeutic drug monitoring for optimal pharmacotherapy adjust the dosage by the pharmacokinetic difference between individuals based on the drug concentration data when the medicine has a well-known therapeutic range of plasma concentration. Recently, TDM for individual patients has become more common clinically with development of Chemical Analysis that extracts drug concentration and its metabolites in biological fluid and introduction of Clinical pharmacokinetics. These new researches in medical-care field and the necessity of clinical application have become gradually increasing.
Adverse Drug Reaction (ADR) Consultation
SNUCPT is a member of the Drug Safety Monitoring Center of SNUH and provides consultation of adverse drug reactions. By performing causality evaluation and clinical pharmacologic interpretation of collected adverse drug reaction in cases when an adverse drug reaction has occurred after drug intake, it can contribute providing a safe drug therapy to patients, further more whole people in Korea.
The Department of Clinical Pharmacology and Therapeutics educates, through systematic training program, effective drug therapy and personalized pharmacotherapy by combining concepts of pharmacology and clinical medicine. By training the systematic and individual research of clinical pharmacology, the education opportunities are expanded and the efficacy of medical education is improved. All trainees are trained to lead the medicine and science of 21st century and become creative and visionary by understanding and utilize the advanced basic and applied science in the aspect of translational medicine.
The clinical pharmacologist training system for resident in Korea has been systematically developed recently. Seoul National University Hospital has recruited and trained clinical pharmacologist since 1988. In resident course, postgraduate medical trainees learn basic knowledge about clinical pharmacology and develop ability for applying personalized pharmacotherapy in patient treatment. In addition, SNUCPT aims to develop ability of medical research by learning clinical pharmacological methods of variability in drug reaction. Since 2007, 2 candidates and 3 from 2011 have been recruited as a part of resident course. The contents of education are described below;
- Clinical PK/PD, therapeutic drug monitoring (TDM) and optimal drug therapy
- Clinical trials in drug development
- Clinical drug research design, implementation, consulting, data analysis and clinical trial simulation
- Clinical research coordination and management
- Drug regimen in special patient populations
(Renal dysfunction, hepatic dysfunction, the elderly, children, etc)
- Adverse drug reactions (ADR), drug-drug Interactions and drug addiction
The Department of Clinical Pharmacology and Therapeutics opens 'pharmacology' course and 'clinical pharmacology' course for undergraduate students. It supports to acquire basic knowledge about clinical pharmacology and develop ability for applying personalized pharmacotherapy in patient treatment. Students are qualifying for translational view of drug research as one of the medical scientist. From 2013, not only the theoretical part, but also the selective practical training course has been preceded with the 4th year students. The contents of education are described below;
- Individual differences in drug response, pharmacogenetics
- New drug development and clinical trials
- Appropriate drug regimen and concepts of the pharmacokinetics and pharmacodynamics
- Therapeutic drug monitoring (TDM)
- Drug-drug interactions
- Adverse drug reactions
- Protocol, informed consent form, and IRB
- The optimal drug therapy in special patient populations
- Drug regulation
- Drug information and labeling
Graduate school education
The aim of the graduate school courses of the Department of Clinical Pharmacology and Therapeutics is to educate professionals to apply clinical pharmacology in clinical practice and research. Research skills of clinical pharmacology are improved by learning phamracogenomics, metabolomics, pharmacokinetic-pharmacodynamic modeling and simulation. The contents of education are described below.
- 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
- Department of Clinical Pharmacology and Therapeutics : http://cpt.snu.ac.kr
- Clinical Pharmacology Graduate school Course : http://www.clinpharmacol.org
- Department of Clinical Pharmacology and Therapeutics: +82-2-2072-4081