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De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development

November 22, 2024 In drug development, early strategic planning is crucial to minimizing risks, optimizing…

CertaraNovember 22, 2024

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A Medical Writer’s Guide to Collaborative Authoring

Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…

CertaraNovember 22, 2024

Blog

Top Three Insights from Certainty Europe

The first European Certainty Conference for the Certara Client Community in Mainz Germany was full…

CertaraNovember 21, 2024

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Mastering Value Storytelling with Data-Driven Stories

Unlocking the Power of Storytelling in Healthcare Communication In the realm of healthcare communication, persuasion…

CertaraNovember 14, 2024

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PBPK Modeling to Support Bioequivalence & Generic Product Approvals

Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally…

CertaraNovember 12, 2024

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Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting

On October 30, 2024, we hosted our Pinnacle 21 Enterprise (P21E) User Group Meeting (UGM)…

CertaraNovember 12, 2024

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4 Ways to Optimize Agency Partnerships Using a Platform-Oriented Approach

In the pharmaceutical and medical devices industries, the journey from product development to market introduction…

CertaraNovember 8, 2024

Blog

Why Clinical Pharmacology & Pharmacometrics Should Collaborate

A symbiosis between a modeler and a trialist is often required to develop a model-informed…

CertaraNovember 8, 2024

Blog

FAQs on Developing EMA Policy 0070 Submissions

In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…

CertaraNovember 1, 2024

Blog

Mathematical Models can Assist in Broadening use of Immuno-oncology Drugs to Treat Autoimmunity

Connecting Cancer and Autoimmunity "The dosing regimens in oncology may not directly inform the optimal…

CertaraOctober 31, 2024

Blog

De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development

A Medical Writer’s Guide to Collaborative Authoring

Top Three Insights from Certainty Europe

Mastering Value Storytelling with Data-Driven Stories

PBPK Modeling to Support Bioequivalence & Generic Product Approvals

Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting

4 Ways to Optimize Agency Partnerships Using a Platform-Oriented Approach

Why Clinical Pharmacology & Pharmacometrics Should Collaborate

FAQs on Developing EMA Policy 0070 Submissions

Mathematical Models can Assist in Broadening use of Immuno-oncology Drugs to Treat Autoimmunity

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