Download the New Smithers Avanza Whitepaper

We are Smithers Avanza Toxicology Services, a division of Smithers Avanza, a well-financed CRO built around quality operations and scientific expertise. We’ve expanded our scientific team, invested in our technical staff through training with recognized industry expert consultants, and purchased state-of-the-art laboratory equipment. These investments and scientific expertise have advanced Smithers Avanza’s toxicology capabilities. Here’s more about what we’ve done:

Internationally recognized toxicologist, Michael A. Dorato, PhD, DABT, Fellow ATS, now leads our Gaithersburg, Maryland Toxicology Services group. Industry veteran, Steven Godin, PhD, DABT, brings over 30 years of CRO experience in toxicology and vaccine safety studies. Dr. Caitlin J. Murphy, an experienced researcher in developmental and reproductive physiology and toxicology, has joined our scientific team. We now offer kinetically-derived maximum dose (KMD) consultation, through Dr. Shakil Saghir, a recognized industry expert.

We retained globally recognized toxicology consultants, Dr. Stephen B. Harris and Dr. Mary Jeanne Kallman to review our operations, provide refresher training, and enhance our scientific expertise. We hired industry veteran, Mr. Jim Hall, to lead our formulations group; quality toxicology studies start with successful dose preparations.

We’ve purchased state-of-the-art laboratory equipment to streamline our operations. We’ve established a leading animal welfare program in the nonclinical CRO industry, and we have a strong track record of regulatory compliance and a well-documented history of on-time reporting.

Download the new whitepaper from Smithers Avanza Toxicology Services:
Reproductive and Developmental Toxicity Testing: Examination of the Extended One-Generation Reproductive Toxicity Study Guideline
Authors:Shakil A Saghir, Ph.D. and Michael A Dorato, Ph.D.

Upon submitting, you will receive an email with a link to download the whitepaper. (* required fields)

Whitepaper summary:

Prior to registration of chemicals, a series of guideline-required toxicological studies are conducted in a number of mammalian species to demonstrate their safety to humans. A number of guidelines have outlined studies to assess toxicity of chemicals to reproductive and developmental stages, from fertilization through adulthood, and in some cases to second generation. Traditionally, a series of animal studies are conducted to assess the developmental and reproductive risk of test chemicals to adults and developing progeny on specific life stage. For example, ICH guideline S5(R2) requires three separate studies to determine effects of test chemicals on fertility and early embryonic development, peri- and postnatal development including maternal function, and embryo fetal development. A similar approach is taken by other regulatory guidelines with the exception of OECD 443 (Extended One-Generation Reproductive Toxicity Study, EOGRTS). This whitepaper discusses ways to make the EOGRTS guideline easier to follow; suggesting procedures to select relevant doses, and monitor the systemic exposure at different life stages for better interpretation of the data.