Final stages of preclinical work in screening of drugs for reproductive
effects to provide data in support of Clinical Trials applications and for marketing.
The studies are best conducted as an integrated sequence, appropriate for the
population that is to be exposed and designed to mimic the intended in-use situation.
For women in particular, age group and contraceptive status are taken into account
in determining the timing of studies.
Studies to International Conference on Harmonisation (ICH) Guidelines
(Topic S5A: Detection of Toxicity to Reproduction for Medicinal Products) are
accepted in all three principle marketing regions of the world (European Union,
Japan and USA).
The main objectives are to assess possible impairment of fetal
development and postnatal functional development arising from direct treatment
of the mother during gestation and lactation. It may also be appropriate to
institute juvenile toxicity studies for materials which may be administered
to children and to bridge the gap between animals treated via the mother and
the older animals used in standard toxicology testing.
- Study for effects on pre- and post-natal development, including maternal
function - monitoring survival, growth and physical development, behavioural
evaluation, sexual maturation and reproductive function. Study required by
all regulatory authorities for marketing approval or earlier if there is cause
of concern.
- Juvenile toxicity studies - monitoring growth and post-natal functional
development in young animals, commonly with a requirement to assess behavioural
performance, recovery from treatment and reproductive performance. Studies
increasingly seen as an integral part of pre-clinical safety evaluation for
drugs which are intended for (or may be used in) the pediatric population.
Studies designed on a case-by-case basis intended to bridge data-gaps between
the pre- and post-natal study and repeat-dose toxicity studies.
Together with our extensive support departments, we provide
the full comprehensive package of tests required for registration and market
authorisation, which ultimately helps speed your product to market.
|
