모델기반 약물개발(MIDD)은 무엇이고, 왜 더 안전하고 효과적인 신약개발 정보를 제공하는데 중요할까요?
Upon watching this video, you will uncover ways to leverage model-informed drug development (MIDD) to maximize the value of your data. 또한, 탐색된 데이터를 넘어 성공적으로 예측할 수 있는 방법을 배울수 있습니다. 이는 귀사의 자산으로 치료적 가능성을 탐색할 수 있게 합니다.
Our experts present on how regulators leverage and apply MIDD and will explain how MIDD has accelerated drug development programs through the optimization of dosing regimens, trial designs, and other key development decisions. 때에 따라 모델기반 약물개발(MIDD)는 일부 임상연구의 필요성을 배재하는 근거가 되기도 합니다.
MIDD: Smoothing the Road to Approval and Beyond
The regulatory landscape is rapidly evolving regarding regulators’ acceptance, even advocacy, of modeling and simulations approaches. Recent examples of this progression include FDA’s Project Optimus and the FDA Modernization Act—both of which have significantly expanded the opportunities to apply MIDD strategies. In this segment, Dr. Krithika Shetty will provide an overview of recent regulatory trends, illustrating how MIDD can help you capitalize on them.
Clinical Pharmacometrics: Your Key to Maximizing the Value of Clinical Trial Data
Pharmacometrics (PMx) is a methodology whereby drug development data is described and interpreted quantitatively using mathematical models. Among the most common applications of PMx are population PK meta-analyses, which have become a de rigueur component of NDA submission packages. Yet, the value of PMx extends far beyond “tick-the-box” regulatory requirements. In this presentation, Dr. Mirjam Trame will explain why the full potential of pharmacometrics is only realized when applied to strategic decision-making regarding treatment and trial design optimization.