Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Blog Post
In this case study, the sponsor’s closing of a manufacturing site required that one of its top-selling products be made at a different facility, triggering FDA to request they demonstrate...
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Blog Post
Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare B-cell malignancies to market. The company leveraged FDA’s accelerated approval program; it was one of...
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Accelerate the creation of regulatory documents with AI-generated content, freeing up writers for key analysis, messaging, and refinement.
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking Blog Post
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…
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…
Raj’s Corner: Blog Roundup Page
Raj’s Corner: Blog Roundup Raj’s corner: Expert strategies for streamlined drug development Explore expert blog posts from Dr. Rajesh Krishna, Certara’s Senior Distinguished Scientist, on best practices for optimizing clinical...
Strategic Planning and technology to support a rolling BLA submission under tight timelines Blog Post
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...
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate Blog Post
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…
