The identification of different responsibilities, under the clear leadership of the medical writer, is necessary to improve the quality of clinical study protocols – to prevent problems and mistakes that can result later, during conduct of the clinical trial, or afterwards, when reporting on trial results.
A look at how to leverage modeling and simulation technology to enhance all phases of the drug development process.
The Critical Path to TB Drug Regimens Initiative partnered with Certara to develop a population-based lung model that mimics drug disposition at different stages of tuberculosis infection.
The formulation team at Impax Laboratories leveraged Certara’s IVIVC Toolkit for Phoenix WinNonlin to optimize generic formulations.
Certara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support developing a fixed-dose combination of ezetimibe and atorvastatin.
Certara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support dose optimization and product positioning of a psoriasis drug.
Scientists from d3 Medicine—part of Certara’s Strategic Consulting division—helped Roche apply an integrated clinical pharmacology program to support the development and global approval of Tamiflu for infants.
During the past few years, model-informed drug development (MIDD) has evolved from a research nicety to a regulatory necessity. Certara is committed to changing the game in drug development by fully leveraging MIDD across the development cycle.
One size does not fit all, reports Certara’s CEO, Edmundo Muniz, and in situations when pharmacokinetic data may be difficult or impossible to obtain, modeling and simulation will stand alone.