The cost of developing new drugs is very high and also time consuming. Efforts aimed at reducing the cost and time to drug approval are of extreme importance. In addition to the traditional drug development methods, new approaches based on the latest scientific knowledge and tools can help reduce both the cost and time it takes to develop and evaluate new therapies.
The extensive use of computer based modeling and simulation is a valuable tool in this process. In its Critical Path Initiative, computational modeling and simulation has been identified as an area that FDA expects to help speed drug development. Modeling and simulation methods are now more commonly used in the drug development process and advances in this area aimed at better prediction of in vivo outcomes can significantly impact how drugs are developed.
There are numerous examples at all stages of drug development where modeling and simulation has enhanced decision making. Modeling and simulation can add value at various stages of the research and development process starting from the pre-clinical to the clinical stages, with continuous feedback at each stage to enhance and improve rationally guided decision making in drug discovery and development. Mechanistic biological models can separately explore the biological and compound specific parameters and integrate the information to predict absorption, distribution, metabolism and excretion (ADME), time-concentration profile of a potential drug candidate.
The need to integrate large amount of data during various stages of drug development, including physiochemical characterization, in vitro assay results, formulation, animal pharmacokinetic (PK) and pharmacodynamic (PD), toxicokinetics, coupled with commercial availability of software packages capable of handling such information has led to increased use of modeling and simulation. Such approaches can be used to address and simulate various clinical and non-clinical outcomes. This process can help in better, faster and informed decision making leading to optimal outcomes including reduced time and cost for drug development.
PKPD Bioscience is a group of experts of modeling and simulation techniques that can advance your drug developmnet process in cost efficent and time saving manner. To learn more, contact our team by clicking here.