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重要な医薬品：Biohaven社の Nurtec™ 医薬品開発のジャーニー

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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Accelerating Oncology Drug FDA Submission with Project Management Services

Discover how Certara’s dedicated project management and pharmacometric support helped an emerging…

How Model-informed drug development rescue projects from a risky situation

Discover how Certara’s integrated approach to model-informed drug development helps clients navigate…

Enabling Personalized Therapy with PBPK Modeling for Pediatric Epilepsy

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

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Delivering DSUR Excellence for Multinational Biopharma

MIDD 専門チームのプロジェクト例：薬事規制関連の課題を克服

希少疾患におけるリアルワールドデータの標準化：ATHNの道のり

Phoenix Hostedを用いて成功を達成：リアルワールドのお客様のストーリー

QSPモデリングにより、多発性骨髄腫治療におけるFIH用量選択を最適化

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

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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

Helping Sponsor Meet EMA Policy 0070 Requirements

Clinical Transparency & Disclosure, Regulatory, Case Study

Streamlining the Preparation of 1-Year and 2-Year PSURs

Regulatory, Case Study

Delivering High-Quality, Timely Responses to EMA Safety Queries

Certara Services, Regulatory, Case Study

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