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丁香实验推荐阅读
Historical Control Data in Reproductive and Developmental Toxicity Studies

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 ...

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Soft Tissue Examination of the Fetal Rat and Rabbit Head by Magnetic Resonance Imaging

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 ...

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Fetal Soft Tissue Examinations by Microdissection

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 ...

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The ICH S5(R2) Guideline for the Testing of Medicinal Agents

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 ...

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Fetal Soft Tissue Examination by Serial Sectioning

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 ...

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Small Animal Imaging and Examination by Micro-CT

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 ...

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Skeletal Examination by Double Staining for Ossified Bone and Cartilaginous Tissue

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 ...

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Skeletal Examination by Alizarin Staining

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 ...

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The Enhanced Pre- and Postnatal Development Study for Monoclonal Antibodies

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. ...

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Embryo fetal Development Studies in Nonhuman Primates

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 ...

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Teratology Studies in the Minipig

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 ...

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Teratology Studies in the Rabbit

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 ...

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Combined Fertility and Embryotoxicity Study

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 ...

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Teratology Studies in the Mouse

The rat is the routine species of choice as the rodent model for regulatory safety testing of xenobiotics such as medicinal products, food additives, and other chemicals. However, the rat is not always suitable for pharmacological, toxicological, immunogenic, pharmacokinetic, or even p ...

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Enzyme-Linked Immunosorbent Assay of IL-8 Production in Response to Silver Nanoparticles

Enzyme-linked immunosorbent assay (ELISA) for monitoring the effects of nanoparticles on immune cells is a conventional method of assessing the levels of cytokine that are released into the culture supernatant after the addition of nanoparticles to a macrophage culture. However, it h ...

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Deriving TC50 Values of Nanoparticles from Electrochemical Monitoring of Lactate Dehydrogenase Activity Indirectly

Nanotoxicity assessment methods for nanoparticles (NPs) such as carbon nanotubes (CNTs), nano-Al2O3, and tridecameric aluminum polycation or nanopolynuclear (nano-Al13), particularly lactate dehydrogenase (LDH) assays are reviewed. Our researches on electrochemic ...

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Application of Reverse Transcription-PCR and Real-Time PCR in Nanotoxicity Research

Reverse transcription-polymerase chain reaction (RT-PCR) is a relatively simple and inexpensive technique to determine the expression level of target genes and is widely used in biomedical science research including nanotoxicology studies for semiquantitative analysis. ...

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Single-Cell Nanotoxicity Assays of Superparamagnetic Iron Oxide Nanoparticles

Properly evaluating the nanotoxicity of nanoparticles involves much more than bulk-cell assays of cell death by necrosis. Cells exposed to nanoparticles may undergo repairable oxidative stress and DNA damage or be induced into apoptosis. Exposure to nanoparticles may cause the cel ...

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Single-Cell Gel Electrophoresis (Comet) Assay in Nano-genotoxicology

The Comet assay, or single-cell gel electrophoresis assay, is an easy and simple yet reliable method to evaluate DNA damage in cells. Under the alkaline conditions of this method, DNA strand breaks and alkaline-labile sites are detected. Here we describe the alkaline version of the Comet assay wi ...

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Methods for Understanding the Interaction Between Nanoparticles and Cells

A critical view of the current toxicological methods used in nanotechnology and their related techniques. Hereby, toxicological effects derived from the intracellular accumulation and uptake will be examined. Then advantages/disadvantages of these methods will be discusse ...

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