How are medicines created?

The process of drug development is long and laborious - a drug market entry may be preceded by more than a decade of research and development. The development of new drugs involves large, interdisciplinary teams of scientists.

How are medicines created?

According to the average data of Roche, the research and development program of a single drug includes 700,874 hours of work, requires conducting 6,587 experiments and the employment of 423 researchers.

The process of creating a drug starts by trying to understand the mechanism of development of a given disease. The researchers then are looking for a way in which they could inhibit this process. After identifying the optimum site of action of the future drug, scientists are increasingly trying to develop a model for future therapies. From thousands of model particles only a few - those with the greatest therapeutic potential - undergo laboratory tests in vitro followed by toxicological tests on animals (so-called preclinical studies). This phase of the study lasts approx. 5-8 years. Not all of the tested particles proceed to the next stage: that of clinical trials on humans.

For a drug to be sent to standard medical practice, after the therapeutic efficacy is proven in clinical trials, it must still undergo a long and complicated registration process which requires the manufacturer to submit detailed analyses and reports.

It is estimated that the total cost of introducing a drug on the market already exceeds $ 4 billion (the average for 2007-2011 amounted to 4.2 billion dollars) and these costs are constantly growing due to stricter requirements regarding research and diagnostic procedures or methods of conducting clinical trials.

More about the process of creating new drugs - watch these movies:

 

The drug discovery process (PhRMA):

 

How a drug becomes a drug (NIH/NIAID):


 

Drug discovery and development process at Novartis:


 

From idea to medicine - drug development at Roche:

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