Meeting the escalating global demand for new medications requires expediting regulatory submission development. Documenting drug safety issues occurring in clinical research is a major aspect of regulatory and medical writing….
In the ever-evolving pharmaceutical landscape, advancing drug development requires innovative tools that seamlessly integrate science and regulatory standards. The release of Simcyp™ PBPK Simulator Version 23 provides an even more…
Learn about biosimilars, their benefits for patients who take biologic drugs, and how pharmaceutical companies demonstrate their bioequivalence to approved biosimilars.
In this video, Dr. Mark Sullivan, Managing Director of Medicines Development for Global Health, explains how Certara’s model-informed drug development expertise was used to support developing moxidectin as a treatment…
This blog reviews the role of the endogenous biomarker, CP-1, for assessing OATP1B transporter-mediated drug-drug interactions and their clinical implications.
Since the FDA passed regulations requiring submitted datasets to be compliant with the CDISC Study Data Tabulation Model (SDTM), clinical trial sponsors have faced a dilemma. Should they design electronic…
Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how these factors could delay regulatory submissions and strategic initiatives.
In this episode of Certara Talks, Jeff Abolafia, Kristin Kelly, and Julie Ann Hood recap their fantastic presentations from PHUSE US Connect earlier this month. The team covered inspirational and…
Transcript:In pharmaceutical research and development, R&D, companies utilize biosimulation and PBPK modeling technologies to identify and develop new therapeutic agents. Biosimulation technology holds immense potential for expediting FDA approvals while…
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