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重塑医药未来：Biohaven 公司 Nurtec™ 药物的研发之旅

In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Nurtec™ (Rimegepant) for the acute treatment of migraines in…

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通过 PBPK 模型推动儿童癫痫个性化治疗

GRIN Therapeutics, Inc., an affiliate of Neurvati Neurosciences, focuses on the research…

Delivering DSUR Excellence for Multinational Biopharma

A global leader in immuno-oncology approached us for support with over 50…

Certara MIDD 专家如何克服客户的监管挑战

Certara’s Model-Informed Drug Development (MIDD) approach leverages an integrated, quantitative systems methodology…

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罕见病真实世界数据标准化：ATHN 之旅

利用 Phoenix Hosted 实现成功：真实世界的客户案例

QSP 建模优化多发性骨髓瘤疗法的首次人体试验剂量选择

Quantitative systems pharmacology model of mRNA lipid nanoparticle for two programs at the preclinical to clinical transition

帮助申办方满足 EMA Policy 0070 要求

简化 1 年期和 2 年期 PSUR 的准备工作

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Quantitative systems pharmacology model of mRNA lipid nanoparticle for two programs at the preclinical to clinical transition

Modeling and Simulation - QSP, Case Study

帮助申办方满足 EMA Policy 0070 要求

Clinical Transparency & Disclosure, Regulatory, Case Study

简化 1 年期和 2 年期 PSUR 的准备工作

Regulatory, Case Study

及时对 EMA 安全性问题做出高质量回应

Certara Services, Regulatory, Case Study

CMC 写作支持帮助客户解除临床搁置状态

Regulatory, Case Study

优化 Charles River 实验室的药代动力学工作流程

Case Study Resources - Featured, Certara Products, Certara Products - Phoenix, Certara Services, Modeling and Simulation, Modeling and Simulation - PK/PD, NCA, Pharmacokinetics, Pharmacometrics, PK/PD, pre-update, Case Study

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案例研究

Featured case study

重塑医药未来：Biohaven 公司 Nurtec™ 药物的研发之旅