Incorporating the patient voice into clinical trial summaries Page
Certara offers Plain Language Documents to meet EMA/UK regulations with customizable templates, infographics, and accessible designs for clinical trial communication.
Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success Blog Post
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an underutilized immunotherapeutics option in oncology, whether as monotherapy or in combinations. The first FDA approval of an ADC was in 2011, with the introduction of...
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies Case Study
In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older. Voxelotor is an oral therapy taken once daily, it...
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta Case Study
Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and the disease. In 2012, FDA approved Ivacaftor (Kalydeco®) for treatment of the underlying cause of CF in a small subset of the patient population. In...
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate On-Demand Webinar
The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing the Flame of a Healthy Debate” published in ASCPT’s CPT Pharmacometrics & Systems Pharmacology exposes the different perspectives around origin, use and ongoing advancement of...
Strategic Planning and technology to support a rolling BLA submission under tight timelines Case Study
A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second submission we supported for this Sponsor in the overall partnership. The agile nature of the submission meant the Certara team would need to be strategic,...
What is BaseCase? Video
Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams is a time-consuming, expensive, and often decentralized process. BaseCase is “no-code” platform that enables you to visualize large complex datasets and economic models, which demonstrates...
Raj’s Corner: Blog Roundup Page
In Raj’s Corner, we’ve assembled a series of expert blog posts that will explain drug development best practices that support the most streamlined and informative clinical development program, to maximize the returns of investment of your program.
Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program Blog Post
In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help facilitate review of New Drug Applications (NDAs)/Biologics License Applications (BLAs) (including supplements) submitted to the Center for Drug Evaluation and Research’s (CDER’s) Office of Oncology...
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking On-Demand Webinar
This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics, Long Island University, NY, USA. Here is a summary of his presentation: • Tizanidine is an alpha2-adrenergic agonist, used to treat spasticity associated with multiple...
