Clinical pharmacology accounts for about 50% of a drug label. Its scope ranges from facilitating the discovery of new target molecules to determining the effects of drugs in different populations. From both industry-wide and regulatory perspectives, the levers of clinical pharmacology can address the huge challenges of late-stage attrition and increase the efficiency of drug development in the quest to bring the “ball” into the end zone.
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 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.
Certara scientists helped Roche apply an integrated clinical pharmacology program to support the development and global approval of Tamiflu for infants.