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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…

モデルを活かした医薬品開発 (MIDD) が医薬品開発の危機的状況をどのように救ったか

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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