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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

Blog

Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program

In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help…

CertaraJuly 21, 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

Case Study

Strategic Planning and technology to support a rolling BLA submission under tight timelines

A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second…

CertaraJuly 19, 2021

On-Demand Webinar

Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate

The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…

CertaraJuly 15, 2021

Case Study

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…

CertaraJuly 14, 2021

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

Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program

What is BaseCase?

Strategic Planning and technology to support a rolling BLA submission under tight timelines

Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

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