Mathematical models are not widely used in the drug development process.

In my utmost post I gave a couple of examples of other industries, in what place use of mathematical models and simulations are integrated mind of the development of new products. Although I single mentioned aero, space, and auto efforts as examples, such models are in certainty used in many other industries. Computer models restore develop new products faster and cheaper anywhere they are used.

High-tech firms are not the and nothing else companies using such models. Management, marketing, and planning teams of dissimilar types of companies are well friendly with the utility of models in workmanship rational decisions. When a manager applies a smallest-square regression method to correlate the whole overhead cost to the number of units sold, s/he is in fact developing a model that can be used to simulate various scenarios and help make daily decisions. Such models are of regularity much simpler than those used ~ means of theoretical physicists but are quite obligatory in helping make crucial decisions.

Most, whether or not not all, pharma and biotech companies are managed through people with scientific or business backgrounds. Mathematical models are commonly used in both science and business decision making. Nevertheless, few companies application these models in their drug exhibition process. In fact, a large enumerate of pharma managers are not equal aware of the existence of similar models and what value they connect to the process. I have given talks to pharma and biotech perseverance people and it always surprises me to observe the reaction of higher management race when I present a case published ~ means of FDA [1]: A company had presented to the FDA results from sum of ~ units phase 3 studies, one meeting the study endpoints and the other deficiency to do so. Based on a pharmacokinetic/pharmacodynamics (PK/PD) shape developed in-house by the FDA scientists, the force approved the new drug. FDA could be favored with easily dismissed the application and asked because of yet another successful phase 3 study. However, by approving the drug based on the image, they provided patients with much-needed handling, while the sponsor company enjoyed savings of millions of dollars and various years of delays.

Developing models require to be paid a fraction of what is worn out on studies with inappropriate designs and takes significantly inferior time. These models have the in posse to save millions of dollars and divide years off the development process. So the inquiry is, why aren’t such models widely used in the assiduousness?

In my coming blogs I desire present some of my ideas in c~tinuance the issue. However, I would like to lead the readers to write their thoughts steady the issue and contribute to the ventilation.

[1]. Bhattaram et al. Impact of Pharmacometric Reviews without interrupti~ New Drug Approval and Labeling Decisions—a Survey of 31 New Drug Applications Submitted Between 2005 and 2006. Clinical Pharmacology and Therapeutics, 2007; 81(2): 213-21

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