Reprotox Studies
Our testing solutions ensure the practical implementation of ICH guideline S5(R2) and appropriate study designs necessary for registering new medicinal products in member countries (European Union, Japan, and the United States). You can rely on Vivotecnia to deliver timely nonclinical reproductive toxicology programs to meet your product development goals and facilitate your product registration.
- STANDARD ICH S5(R2) STUDY DESIGNS
- DEVELOPMENTAL AND REPRODUCTIVE TOXICITY TESTING OF VACCINES
- ALTERNATIVE ANIMAL MODELS: GUINEA PIGS AND HAMSTERS
- 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
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.
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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
Methodology
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
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