• Question: How do you test your new drug to ensure that it is safe?

    Asked by ring42air to Sudhin, Sergio, Katie, Frances, Diarmuid, Aoife on 20 Nov 2019.
    • Photo: Diarmuid Kenny

      Diarmuid Kenny answered on 20 Nov 2019:

      There are known tests you can use to see if a certain drug hits known proteins that would cause toxicity. Some companies can screen for those using, for example, cells grown on plates or other methods. However, it is also likely that you will need to test in some animals to check that your drug doesn’t go into certain organs, cross the blood brain barrier etc. Eventually we will test the drugs in healthy males (why not woman you ask? Generally to avoid any issues around reproduction. It is safer to test in men where infertility is less common). Once the healthy males are ok, we can then put a drug into patient

    • Photo: Katie Fala

      Katie Fala answered on 21 Nov 2019:

      First I’ll probably be characterising the effects on ‘bad’ bacteria – so applying different forms/doses and monitoring the behaviour of the bacteria (such as growth rate, biofilm formation) to see if they react in any unexpected way. Then when considering interactions with the human body, I suppose we’ll need to consider how the drug could affect the microbiota (so the community of bacteria, fungi and viruses that live in different parts of your body, such as the gut) as well as the cells, tissues and organs of the body using lab-based tests.Or if the application were to be in removing biofilms of pathogenic bacteria from food processing plants, we’d need to check and see if any of the compound ended up in the food. Overall, new drugs have to pass clinical trials before being given approval – these generally involve several phases with thousands of people in order to show that it is safe, effective and to document possible side effects. This process takes about 10 years, but is necessary to ensure that it is safe and that people won’t be harmed.