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Reproductive toxicants may adversely affect sexual function, ovarian failure, fertility as well as causing developmental toxicity in the offspring. [2] [3] Lowered effective fertility related to reproductive toxicity relates to both male and female effects alike and is reflected in decreased sperm counts, semen quality and ovarian failure.
The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.
Developmental toxicity is any developmental malformation that is caused by the toxicity of a chemical or pathogen. It is the structural or functional alteration, reversible or irreversible, which interferes with homeostasis, normal growth, differentiation, development or behavior.
In pharmaceutical research, toxicogenomics is defined as the study of the structure and function of the genome as it responds to adverse xenobiotic exposure. It is the toxicological subdiscipline of pharmacogenomics, which is broadly defined as the study of inter-individual variations in whole-genome or candidate gene single-nucleotide polymorphism maps, haplotype markers, and alterations in ...
Reproductive Toxicology is a peer-reviewed journal published bimonthly by Elsevier which focuses on the effects of toxic substances on the reproductive system. The journal was established in 1987 and is affiliated with the European Teratology Society. According to the Journal Citation Reports, the journal has a 2023 impact factor of 3.3. [1]
In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
A box model explaining the processes of toxicokinetics and toxicodynamics. While toxicokinetics describes the changes in the concentrations of a toxicant over time due to the uptake, biotransformation, distribution and elimination of toxicants, toxicodynamics involves the interactions of a toxicant with a biological target and the functional or structural alterations in a cell that can ...
A well designed toxicokinetic study may involve several different strategies and depends on the scientific question to be answered. Controlled acute and repeated toxicokinetic animal studies are useful to identify a chemical's biological persistence, tissue and whole body half-life , and its potential to bioaccumulate.