• Question: what are the two reasons most drugs do not make it through the development process?

    Asked by lozzc to Darren, Deuan, Duncan, Lori-An, Michelle on 15 Jun 2010 in Categories: . This question was also asked by ellenb123, izzie.
    • Photo: Lori-An Etherington

      Lori-An Etherington answered on 15 Jun 2010:

      This is a good question. There are a number of reasons why drugs don’t make it through the development process. There are two main parts to the drug development process, preclinical (tested on cells and animal models) and clinical (clinical is when the drug is tested on humans but is not yet approved by the goverment for use), the main reasons why drugs fail probably differs slightly between these two phases of development. Drugs mainly fail because they are not safe enough (one example might be that they might be damaging to organs in the body), they are not taken up by the body (poor absorbtion) or removed properly from the body (poor excretion), they do not work as well as predicted (poor efficacy) or the cost of production is too high. Many drugs fail in preclinical trials because they do not pass standard safety tests or they are have poor absorption or excretion. Whereas in clinical trials most drugs probably fail due to unacceptable side effects or poor efficacy.
      Hope this helps to answer your question.

    • Photo: Darren Nesbeth

      Darren Nesbeth answered on 15 Jun 2010:

      Two major reasons are:

      1) it is so difficult to manufacture the drug that it would be too expensive to make
      2) there are problems with manufacturing the drug to be pure enough, or of a good enough quality

      both those problems are answered by biochemical engineering

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