Reproductive Toxicology for Pharmaceutical Products: Ensuring Safety and Compliance

Reproductive toxicology is a critical aspect of pharmaceutical product development. It involves the study of substances that affect the reproductive system and may cause disorders such as infertility, developmental issues, and birth defects. At Vivotecnia, we offer comprehensive reproductive toxicology services for pharmaceutical products, ensuring safety, efficacy, and regulatory compliance.

Understanding Reproductive Toxicology in Pharmaceutical Products

Reproductive toxicology studies are designed to identify, characterize, and quantify the potential risks of pharmaceuticals to the reproductive health of both males and females. These studies are crucial in assessing the potential effects of substances on fertility, embryonic development, and postnatal development.
Pharmaceuticals can sometimes have unanticipated and complex impacts on reproductive capacity and embryonic development. They can affect sexual function and fertility in adult males and females or lead to malformations, developmental retardations, or mortality of the fetus when pregnant women are exposed. Over the past 30 years, our understanding of embryogenesis and mechanisms of developmental toxicity has greatly advanced, as has the regulatory framework of developmental and reproductive toxicology (DART) studies.

Compliance Guidelines in Reproductive Toxicology for Pharmaceutical Products

Pharmaceutical product development is subject to a range of compliance guidelines that dictate the necessary reproductive toxicology studies. These guidelines are set forth by regulatory bodies such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The specific requirements depend on the stage of pharmaceutical development and the intended patient population:

  • ICH S5(R3) Guideline: This guideline provides a comprehensive framework for the conduct of reproductive toxicology studies for pharmaceuticals. It outlines the types of studies required, including fertility studies, embryofetal developmental toxicity studies, and pre- and postnatal developmental toxicity studies. The guideline also provides detailed recommendations on study design, data interpretation, and regulatory decision-making.
  • ICH M3(R2) Guideline: This guideline provides recommendations on the timing of reproductive toxicology studies in relation to clinical development. It outlines when these studies should be conducted to support the safe use of pharmaceuticals in humans.

Importance of GLP Compliance

Good Laboratory Practice (GLP) is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies. As a GLP-compliant Contract Research Organization (CRO), Vivotecnia ensures that all our reproductive toxicology studies for pharmaceutical products are conducted in accordance with these principles. This not only ensures the reliability and integrity of our studies but also facilitates regulatory approval of your pharmaceutical products.

Who Needs Reproductive Toxicology Services?

Reproductive toxicology services are essential for any company involved in the development and marketing of pharmaceutical products. This includes pharmaceutical companies, biotech companies, and academic institutions. These services are crucial in ensuring the safety of these products and their compliance with regulatory requirements.

Segment I: Fertility and early embryonic development in rat/mouse

  • Female fertility study
  • Male fertility study
  • Combined female and male fertility studies

Segment II: Embryofetal development in rat/mouse/rabbit

  • Preliminary dose-range-finding embryofetal developmental studies
  • Definitive embryofetal developmental studies

Segment III: Prenatal and postnatal development in rat/mouse

  • Preliminary dose-range-finding studies
  • Definitive prenatal and postnatal development studies
The ICH reproductive toxicity guidelines (S5(R2) 2005) are now applied worldwide for reproductive and developmental toxicity testing of new pharmaceuticals (Barrow, Reprod Toxicol. 2009 Sep;28(2):172-9). These ICH study designs, however, are not applicable for testing vaccines.

In 2006, the CBER division of the FDA issued a guidance document “Considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications”, which gives specific recommendations on study designs and experimental methods (FDA, 2006a). This document is practically the sole guideline used today for designing nonclinical developmental studies for vaccines.

Models other than the rat, rabbit and nonhuman primate can be used to evaluate the effects of biotherapeutics in reproductive, developmental and juvenile toxicology studies.
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Our team and experience

Vivotecnia offers the high level of scientific expertise needed to address special DART regulatory study requirements, including fertility, developmental toxicity (teratology), juvenile studies and multigenerational reproductive studies. Tests can be performed using a wide selection of administration routes, for example dermal or intravenous infusion. Our designs are customized to individual sponsor needs in line with regulatory guidances, encompassing FDA, EMEA, and OECD standards.

At Vivotecnia we are experienced and skilled in assessing all necessary endpoints:

Maternal evaluation

  • Necropsy
  • C-sections
  • Uterine examinations

Post-mortem fetal evaluations in multiple species and strains

  • External morphology
  • Visceral
  • Skeletal

Neurobehavioral assessments

  • Motor activity
  • Learning
  • Memory
  • Acoustic startle response

Sperm evaluation

  • Concentration
  • Count
  • Motility
  • Morphology

Developmental and Reproductive Toxicity Testing for Pharmaceuticals

  • Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, ICH M3(R2), June 2009
  • Detection of toxicity to reproduction for medicinal products & toxicity to male fertility, ICH S5(R2), November 2005
    • Segment I: Fertility and early embryonic development in rat/mouse
    • Segment II: Embryofetal development in rat/mouse/rabbit
    • Segment III: Prenatal and postnatal development in rat/mouse
  • FDA Guidance for industry on considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications, February 2006

Contact Us Today

At Vivotecnia, we are dedicated to helping our clients ensure the safety and efficacy of their pharmaceutical products through comprehensive and reliable reproductive toxicology testing services. If you need assistance with reproductive toxicology testing for your pharmaceutical products, contact us today. Our team of experts is ready to assist you with your testing needs.
Ready to ensure the safety and efficacy of your pharmaceutical products with comprehensive reproductive toxicology testing? Contact us today to learn more about our services and how we can assist you. Fill out our contact form, and one of our representatives will get back to you as soonas possible.
Remember, at Vivotecnia, your product’s safety is our priority. Let us help you make the world a safer place.

Help, question Icon     Frequently Asked Questions about Reproductive Toxicology Services


General Reprotox

You can trust Vivotecnia to carry out preclinical reproductive toxicology studies which ensure that your product development objectives are met, thereby facilitating product registration.

Reprotox for Chemical

At Vivotecnia, we offer comprehensive reproductive toxicology services for chemical products, ensuring safety, efficacy, and regulatory compliance.



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