Recently there is great support for including female animals in the preclinical research. As far as I understood, the main idea behind this is the idea that using male animals in preclinical research cannot easily reflect the effects of tested drugs in women patients.
I am curious is there any scientific evidence showing the experiments done in female animals better translate the clinical situation in women patients?
Dear Hakan,
normally and with very few exceptions, female animals always have to be included into regulatory acceptable preclinical studies. Exceptions are some in vivo genotox studies where male rats/mice have a proven higher susceptibility. If you refer to the respective ICH guideline documents, that is stated clearly. Some experimental work, especially in reproductive toxicology, ONLY can be conducted in females ;-).
Hope that answers your question.
All the best, Geertje
Dear Hakan,
As Geertje indicated regulatory toxicology needs to be evaluated in both male and female animals, except where studies are specific to one sex.
This is different in pharmacological studies in which often models are standardized with one sex only. Not necessarily because the disease is relevant to only one. However, many models use only females, not always only males.
PK studies are more often done in males. Mainly because they are not as useful as females for breeding.
There are meaningful differences between sexes for some compounds. These are not always directly translatable to human. So it always need to be looked at carefully. In particular when differences are observed in toxicology studies (where both sexes are tested), efforts should be spent to understand how this will be relevant to human. This can include differences in toxicokinetics as well as actual safety endpoints.
More importantly it is essential to include women in clinical trials to have a representative population. Traditionally women were under-represented, in good part to avoid any risk with embryo-fetal development. This extends to the inclusion of a representative population also in terms of geographic origins, age, co-morbidities
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