How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline
Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the…
CertaraAugust 16, 2021
Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations
The era of gene therapy may have started a couple of decades ago, but approvals…
CertaraAugust 13, 2021
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
Succeeding in Value Communication: Introduction
Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding…
CertaraAugust 5, 2021
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
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
Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program
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
What is BaseCase?
Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams…
CertaraJuly 20, 2021
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
