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Pharmacometrics
Pharmacometrics
Pharmacometrics
Pharmacometrics
Model-Informed Drug Development: 모델 기반 신약개발과 의사결정
FDA 신약 심사의 New Normal: MIDD와 Quantitative Medicine
동물실험 대체와 NAMs: FDA Modernization Act 3.0
중개 연구의 중요성: PK/PD 상관관계
Quantitative Systems Pharmacology: 타겟 식별부터 개념 증명까지
가상 임상시험(In silico Trials) 및 Bayesian 방법론
최적의 First-in-human 용량설정: 임상 기간 단축 및 비용 절감
임상시험 면제(Waiver) 전략: Population PK/PD 모델링, PBPK 모델링
사후 분석(Post-hoc Analysis)의 한계와 MIDD 기반 임상 설계의 역할
AI-Enhanced Modeling & Simulation : 기술적 실증
MFDS의 MIDD 도입 방향 및 정책
Model Informed Drug Discovery and Development (MID3)
Model Informed Drug Discovery and Development (MID3)
We use MID3 as a holistic term to characterize a variety of quantitative approaches used to improve the quality, efficiency, and cost-effectiveness of decision-making through ‘‘fit-for-purpose’’ data analysis and prediction.
MID3 ‘‘Quantitative Framework’’
MID3 ‘‘Quantitative Framework’’
MID3: a quantitative framework for prediction and extrapolation centered on knowledge and inference generated from integrated models of compound, mechanism, and disease level data aimed at improving the quality, efficiency, and cost-effectiveness of decision-making.
The colored boxes represent essential components of the ‘‘Learn and Confirm Cycle’’.
The arrows represent processes that link these components.
Pharmacometrics in Drug Discovery and Development
Pharmacometrics in Drug Discovery and Development
The discipline of pharmacometrics has grown for more than two decades as a quantitative framework where knowledge is integrated to support decision-making in drug discovery and development.
Implementation of pharmacometric modeling and simulation tools in this field have emerged and established as a key component to optimize the drug development process, gaining increased support from the pharmaceutical industry, academia, and regulatory agencies.
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