Reproductive Toxicity Evaluation

Reproductive toxicity evaluation involves the assessment of potential adverse effects of chemical substances, pharmaceuticals, or environmental agents on reproductive health and the reproductive processes of both males and females. This type of evaluation is crucial in determining the safety of these substances for humans and other animals, particularly regarding their effects on fertility, pregnancy, and the development of offspring. All types of drugs, including oligonucleotide therapeutics, need to be evaluated for reproductive toxicity.

General Design of Reproductive Toxicity Studies

The International Conference on Harmonisation (ICH) guideline S5(R2) provides recommendations for the reproductive toxicity evaluation of drugs. Oligonucleotide therapeutics are also suitable for these recommendations. This guideline recommends that all aspects of the reproductive cycle be evaluated, from gamete development to offspring sexual maturation, and recommends the use of three separate study designs for evaluation. The three studies described in ICH S5(R2) include fertility and early embryonic development (FEED), embryo-fetal development (EFD), and pre‐/postnatal development (PPND) studies, also historically referred to as segment I, II, and III studies, respectively.

FEED studies are usually conducted in rodents and are designed to assess reproductive function and early development of embryos through implantation. These studies can evaluate the effects of oligonucleotide therapeutics on pregnancy rate, ovulation, fertilization, implantation of fertilized eggs into the uterus, and development of the embryo through the time of implantation.

EFD studies have traditionally been conducted in one rodent species and one nonrodent species, typically rabbits. The purpose of these studies is to assess fetal survival, growth and morphology by examining the external, visceral and skeletal characteristics of the fetus.

In PPND studies, rodents are generally used to evaluate the functional consequences of in utero and lactational exposures. These studies provide important data for understanding the reproductive and developmental toxicity of oligonucleotide therapeutics.

What We Offer?

With experienced experts and state-of-the-art equipment, Alfa Chemistry is able to provide customers with reproductive toxicity evaluation services and related technical advice for oligonucleotide therapeutics. We are committed to:

Our products and services are for research use only and cannot be used for any clinical purposes.

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