Testing for Pharmaceuticals Products
In accordance with the requirements of ICH M3 guideline on Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, evaluation of developmental and reproductive toxicology (DART) endpoints is a fundamental part of the non clinical safety assessment program for compounds with potential use for women of childbearing age or who might be exposed to them during pregnancy.
Our testing solutions ensure the practical implementation of ICH S5 (R2) guideline on Developmental and Reproductive Toxicity Testing for Pharmaceuticals and adequate study designs needed for registration of 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 meeting your product development goals and facilitating your product registration.
- STANDARD ICHS5 STUDY DESINGS
- DEVELOPMENTAL AND REPRODUCTIVE TOXICITY TESTING OF VACCINES
- ALTERNATIVE ANIMAL MODELS: GUINEA PIGS AND HAMSTERS
Segment I: Fertility and Early Embryonic Development in Rat/Mouse
- Fertility study in Female
- Fertility study in Male
- Combined fertility study in female and male
Segment II: Embryo Fetal Development in Rat/Mouse/rabbit
- Preliminary dose-range embryo-fetal developmental studies
- Definitive embryo-fetal development studies
Segment III: Prenatal and Postnatal Development in Rat/Mouse
- Preliminary dose-range finding studies
- Definitive Prenatal and Postnatal development studies
The ICH S5 guidelines (ICH, 2005) are now applied worldwide for the reproductive toxicity testing of new pharmaceuticals for reproductive and developmental toxicity (Barrow, 2009). These ICH study designs, however, are not applicable for the testing of vaccines.
In 2006, the CBER division of the FDA issued a guidance document on “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 generally used today as the sole guideline for the design of non-clinical 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
Testing for Chemicals Products
Our testing solutions ensure the practical implementation of REACH requirements on developmental and reproductive toxicity testing requirements according tonnage marketed per year.
- INFORMATION REQUIREMENTS AT 10 TPA:
Where there are no concerns over reproduction or development REACH calls to start with the screening study (OECD421/422) at this tonnage.
Where there are serious concerns about the potential for adverse effects on fertility or development, either a pre-natal developmental toxicity study or a two- or extended one generation reproductive toxicity study may be proposed instead of the screening study.
- INFORMATION REQUIREMENTS AT 100 TPA
REACH requires a pre-natal developmental toxicity study in one species (usually rat) If the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues conduct a two-generation or extended one-generation reproductive toxicity study in one species.
- INFORMATION REQUIREMENTS AT 1000 TPA
REACH requires a pre-natal developmental toxicity study in one species (usually rat). Need for a second species judged on a case-by-case basis Two-generation or extended one-generation reproductive toxicity study in one species. Need for a second species judged on a case-by-case basis
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