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Frog embryo teratogenesis assay on Xenopus (FETAX) has been routinely used in our laboratory for the last 12 years as a routine developmental toxicity screening test for pharmaceutical candidate compounds. To date, out of more than 400 candidates tested in FETAX, around 60 have also been evalu ...

As a model for teratogenicity research, zebrafish are gaining popularity and creditability. Zebrafish embryos have been proven to be a highly valuable tool in genetics and developmental biology research and have advanced our understanding of a number of known developmental toxican ...

The embryonic stem cell test is an animal-free alternative test method for developmental toxicity. Mouse embryonic stem cells are cultured in a hanging drop method to form embryoid bodies. These embryoid bodies, when plated on tissue culture dishes, differentiate to form contracting my ...

Understanding the potential health risks posed by environmental chemicals is a significant challenge elevated by the large number of diverse chemicals with generally uncharacterized exposures, mechanisms, and toxicities. The ToxCast computational toxicology research ...

Toxicological hazard assessment currently finds itself at a crossroads where the existing classical test paradigm is challenged by a host of innovative approaches. Animal study protocols are being enhanced for additional parameters and improved for more efficient effect asses ...

Although demonstration of some degree of maternal toxicity is required in regulatory developmental toxicology studies, marked maternal toxicity may be a confounding factor in data interpretation. Reduction in maternal body weight gain is the far most frequently used endpoint of to ...

The regulatory toxicology report is an unusual document that requires a particular skill to write. The report must be clear, accurate, concise, and focused. A clear and direct writing style is required. The end-users of the report will hope to find the information they seek with as little effort as pos ...

Reproductive and developmental toxicity studies in laboratory animals are conducted as part of the process of evaluating the risk of pharmaceuticals and chemicals to human reproduction and development. In these studies, comparison of data from groups dosed with the test article to a con ...

The use of magnetic resonance imaging of the fetal rat and rabbit head, as an alternative to the traditional methods of fixation and preparation of serial sections, is described. Labeled magnetic resonance images of normal head anatomy have been provided as a reference for use when evaluating t ...

This chapter describes methods for the examination of fetal abdominal and thoracic soft tissues by microdissection on either fresh (non-rodent) or fixed (rodent) specimens in order to detect structural abnormalities. With hundreds of fetuses examined for each species (rodent and no ...

Relying on previous regulatory guidelines from multiple countries, the ICH S5(R2) guideline outlines the preclinical safety studies needed for registration of new medicinal products in the member countries (European Union, Japan, and the United States). The primary purpose of the gu ...

This chapter describes the method used for serial sectioning and soft tissue examination of the Bouin’s fixed fetus (mainly whole rat and or mouse fetuses or rabbit fetal heads) for the assessment of developmental and structural abnormalities. Fetuses are examined externally, together ...

Micro-computed tomography imaging technology allows for the whole-mount investigation of skeletal structures in preclinical specimens at both fetal and postnatal time points. The imaging process is nondestructive to the specimen and can be performed at various resolutions to d ...

The assessment of developmental toxicology data is a critical aspect of hazard evaluation for pharmaceuticals and environmental chemicals. Skeletal examination is an essential part of prenatal developmental toxicity studies of chemicals as well as pesticides and comprises e ...

A skeletal examination of fetuses is required in regulatory embryo–fetal development studies. This chapter describes a method of skeletal examination using alizarin staining. All fetuses are removed from the mother by caesarean section before birth. The fetuses are first examined e ...

The enhanced pre- and postnatal (ePPND) study design has been developed in response to new scientific knowledge and subsequent guideline changes . The changes in study design were basically driven by the experiences obtained during preclinical development of biopharmaceuticals. ...

Embryo fetal development (EFD) studies in nonhuman primates are frequently conducted in macaques with Macaca fascicularis (cynomolgus monkey, long-tailed macaque, crab-eating macaque) being the most accepted model. EFD studies are also feasible in the marmoset. Due to recent guid ...

The minipig is a suitable species for regulatory teratology testing and may be regarded as an alternative to the rabbit, dog, and primate. The first successful regulatory teratology studies in the minipig were performed in the 1990s. It became clear that minipigs have several benefits over the o ...

The rabbit is generally the non-rodent species or second species after the rat recommended by the regulatory authorities and is part of the package of regulatory reproductive studies for the detection of potential embryotoxic and/or teratogenic effects of pharmaceuticals, chemic ...

Under normal circumstances, fertility and embryotoxicity studies are run separately according to the ICH S5(R2) guideline for the detection of toxicity to reproduction of medicinal products (1). However, the flexible approach of the S5(R2) guideline also allows the reproduction sta ...