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药代动力学/药效学（PK / PD）建模
Metabolism, Modeling
定量和/或系统药理学（QSP / SP）建模
录制类型：建模（计算机）
QSP / SP型号可用于第一载（FIH）给药，概念证明（POC®）研究设计和患者分层的理由。QSP/SP models are frequently used to support the development of large and small molecules with novel/multiple mechanisms.
定量和/或系统药理学（QSP / SP）是一种建模方法，它集成了临床前机械证据和生理系统模型来调查和预测药物反应。yaboapp体育官网
A subdiscipline of pharmacokinetics (PK), systems pharmacology is conducted using ordinary differential equations (ODEs) that interact with existing PK models to better predict clinical trials.
QSP/SP modeling is not specifically required in regulatory guidance, but e.g., the FDA has strongly suggested including modeling in your data package upon submission.
About our nonclinical animal research models: We provide the utmost care for our research animals and actively pursue advances in animal welfare. As well as ensuring the highest scientific, ethical and regulatory standards, selection of appropriate animal research models for development research is critical to developing safe and effective treatments, devices and products that protect and save lives. Just as we have ethical committee oversight for human trials, we have ethical committees overseeing all aspects of our global animal care and use programs. All of our core, nonclinical facilities are accredited by AAALAC.了解有关我们对更换，重新塑造和炼制非临床研究模式的承诺。