Hwi-yeol Yun (1), Chung Hee Lee (1), Sung Yoon Yang (1), Thi Quyen Tran (1), Woo Jin Jung (1), Seon Jong Park (1), Thi Lien Ngo (1), Jung-Woo Chae (1), Minjee Kim (2), Min-Gul Kim (2),(3), Eben Jung(4), Ki soon Kim (4), Woo-Yong Oh (4), Yoonsook Lee (4)
(1) College of Pharmacy, Chungnam National University, Korea, (2) Center for Clinical Pharmacology, Chonbuk National University. Korea (3) School of Medicine, Chonbuk National University. Korea (4) Clinical Research Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Korea
Objectives: The importance of model based drug development (MBDD) and evidence based pharmacotherapy have been evolved during last two decades, pharmametrics (PM) accordingly has become a useful science because of its quantitative characteristics [1,2]. According to these trends, many of models were presented by pharmacometricians and its application also was increased on drug development and clinical settings. Nevertheless, scientists who have willingness to learn PM, still have suffered by its high barrier and issues about model quality control were emerged among pharmacometricians.
Methods: To overcome the limitation, especially in Korea, Korean College of Clinical Pharmacy(KCCP), Korean Society for Clinical Pharmacology and Thearpeutics (KSCPT) and Ministry of Food and Drug Safety(MFDS) have developed Korean Pharmacometric Model Repository (KPML) to share knowledge and understanding of model based drug research and development with Korean pharmacometricians at 2018. Consequently, nowadays we are trying to emphasize KPML functions to satisfy those unmet need from user groups and also expand to user groups through increment of accessibility.
Results: In KPML, total 50 models, running for population pharmacokinetic (PK), physiologically based PK (PBPK) and exposure-response (PK/PD) model with NONMEM, Phoenix and the others, were opened in website (http://repository.kpml.or.kr) and the users are able to download and use those without barriers. The model was listed by name of drugs, disease, dataset origin and data description and results text file were supported as well for easy comparison with own results. Pharmacometrics training course were also opened as introductory and advanced course to cover all levels of pharmacometricians. Since training course consisted of lecture, hands-on and solution file, pharmacometricians can be studied by himself with those kinds of materials. In addition, PK functions, demanded a lot from related researchers, were opened (Non-compartmental analysis (NCA), compartment modelling without software, allometric scaling for prediction of first-in-human dose) and in-vitro/in-vivo extrapolation (IVIVE) to predict organ clearance).
Conclusions: The importance of Pharmacometrics is increasing depending on trends of MBDD, however, there are still limitation to apply it fluently in Korea because of own characteristic. Therefore, we developed and opened KPML working through collaboration between academia and national institutes to spread out for pharmacometrics knowledge from beginner to expert in Korea.
Acknowledgement: This research was supported by a grant (18182MFDS405 and 19182MFDS427) from Ministry of Food and Drug Safety in 2018 and 2019, respectively.
References:
[1] Kimko H., Pinheiro J.,Model-based clinical drug development in the past, present and future: a commentary. British Journal of Clinical Pharmacology (2015) 79(1): 108-116.
[2]Kim TH., Shin S., Shin BS., Model-based drug development: application of modelling and simulation in drug development. Journal of Pharmaceutical Investigation (2018) 48: 431-441.
Reference: PAGE () Abstr 9412 [www.page-meeting.org/?abstract=9412]
Poster: Methodology - Other topics