SQA 2023 -- Quality is at the core of the GLP compliance organization. But how does building in quality create a compliance culture? Culture is a set of beliefs, values and assumptions that are shared by the organization and compliance is the behavior and integrity that builds trust.

SQA 2023 -- Contract Research Organizations (CROs) and their Sponsors need to work together to have successful studies with the goal of the studies being accepted by a regulatory agency for submission. In order to achieve success, the CRO and the Sponsor have to understand their roles under the GLPs along with the responsibilities.

As clinical development evolves to enhance solutions for sponsors, the demand for hybrid designs in studies requiring early patient data continues to grow. While there are many benefits to running hybrid protocols, there are several challenges that must also be mitigated.

IUPAC 2023 -- Why is radioactivity required in regulatory studies of crop protection products? Imagine one individual in a crowd of 100,000 people - they would be difficult to locate. But give this individual a large flag to wave and there they are - easy to see.

IUPAC 2023 -- Globally recognised European Commission (EC) methods are used for hazardous testing. However, as part of the Classification, Labelling and Packaging (CLP) regulations for the transporting of materials, the required testing follows the UN testing regulations.

SOT 2023 -- Regulatory guidelines necessitate carcinogenicity studies to identify the tumorigenic potential in rodents and to assess the relevant risk in humans. The assessment of the intended chemical's ability to induce tumors in rodents helps with the prediction of the relevant risk in humans.

SOT 2023 -- Locomotor activity is used in general toxicology as well as developmental and reproductive toxicology studies to assess neurobehavioral and/or neuromuscular changes caused by test material administration.

SOT 2023 -- The use of rodents as a small animal in vivo model for nonclinical drug safety testing is essential as part of IND and NDA applications to the FDA. More animals are often required for small animal studies compared to large animal studies due to various factors, including blood volume limitations and sample size needed for significant analysis.

SOT 2023 -- Assessment of neurobehavioral effects is an important end point in the preclinical safety evaluation of new drugs and chemicals. Sprague Dawley rats are most often used for neurobehavioral phenotyping due to their widespread use in toxicology research.