Biologics Archives

Publication

Population Pharmacokinetics for Belantamab Mafodotin Monotherapy and Combination Therapies in Patients with Relapsed/Refractory Multiple Myeloma

Explore comprehensive population pharmacokinetic analyses of belantamab mafodotin, evaluating both monotherapy and combination regimens in…

CertaraAugust 13, 2025

Publication

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Explore updated results from the Phase 3 TROPiCS-02 trial of Sacituzumab Govitecan in advanced HR+/HER2–…

CertaraAugust 13, 2025

Announcement

Certara Announces D360 25.5 Release, Featuring Dynamic Data Subsets and Enhanced Analytics

D360 v25.5 allows scientists to divide up a dataset into series of compounds & perform…

CertaraAugust 7, 2025

Press Coverage

Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics

Explore insights from Certara experts on how PK/PD modeling streamlines biologic drug development.

CertaraAugust 5, 2025

Webinar

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

CertaraAugust 1, 2025

Press Coverage

FDA plans to phase out animal testing requirements

Discover how the FDA plans to replace animal testing with AI and organ-on-chip technologies for…

CertaraApril 10, 2025

Publication

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…

CertaraMarch 4, 2025

Press Coverage

2025 cell and gene challenges: Scalability, supply chain and manufacturing

Explore insights on 2025 challenges in cell and gene therapy, including commercial viability, with expert…

CertaraFebruary 3, 2025

Press Coverage

AI in Life Sciences Finds an Early Success and Will Continue in 2025

Fran Brown highlights how AI in life sciences drives more precise drug development and reduces…

CertaraDecember 24, 2024

Blog

CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of

December 13, 2024 The Centers for Medicare & Medicaid Services (CMS) is piloting a program…

CertaraDecember 13, 2024

Biologics

Population Pharmacokinetics for Belantamab Mafodotin Monotherapy and Combination Therapies in Patients with Relapsed/Refractory Multiple Myeloma

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Certara Announces D360 25.5 Release, Featuring Dynamic Data Subsets and Enhanced Analytics

Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

FDA plans to phase out animal testing requirements

Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach

2025 cell and gene challenges: Scalability, supply chain and manufacturing

AI in Life Sciences Finds an Early Success and Will Continue in 2025

CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of

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