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Case Study

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…

CertaraAugust 12, 2021

On-Demand Webinar

What does the Clinical Pharmacology Plan for a Biologic Look Like?

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and…

CertaraAugust 6, 2021

Press Release

Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data

Transaction expected to be accretive to Certara’s revenue, revenue growth and adjusted EBITDA margin Princeton,…

CertaraAugust 5, 2021

Blog

Succeeding in Value Communication: Introduction

Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding…

CertaraAugust 5, 2021

Case Study

Takeover of lifecycle maintenance of investigational new drug applications

A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy with their current vendor’s support. The Sponsor selected Certara as its new vendor for…

CertaraAugust 2, 2021

Publication

Application of Quantitative Systems Pharmacology to guide the optimal dosing of COVID-19 vaccines

Optimal use and distribution of coronavirus disease 2019 (COVID-19) vaccines involves adjustments of dosing. Due…

CertaraJuly 31, 2021

Case Study

Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study

In this case study, the sponsor’s closing of a manufacturing site required that one of…

CertaraJuly 29, 2021

Case Study

DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…

CertaraJuly 29, 2021

On-Demand Webinar

PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking

This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics,…

CertaraJuly 26, 2021

Video

What is BaseCase?

Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams…

CertaraJuly 20, 2021

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

What does the Clinical Pharmacology Plan for a Biologic Look Like?

Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data

Succeeding in Value Communication: Introduction

Takeover of lifecycle maintenance of investigational new drug applications

Application of Quantitative Systems Pharmacology to guide the optimal dosing of COVID-19 vaccines

Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study

DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking

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