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March 12, 2023

CROs and Sponsor relationships - review of responsibilities for successful study conduct and reporting

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.

March 13, 2023

Optimizing Phase Ib with the right partner

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.

March 14, 2023

Synthesis of radiolabelled crop protection products from carbon-14 building blocks

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.

March 14, 2023

A global approach to determine hazardous physical properties

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.

March 15, 2023

Expediting a pediatric vaccine trial through site- and participant-centric practices

In collaboration with Labcorp Drug Development and academic investigators, a large pharmaceutical company launched a study to prevent respiratory syncytial virus (RSV), a common seasonal virus that often has mild symptoms but can cause hospitalization and death in newborns and infants.

March 19, 2023

Comparative analysis of historical control data in CD (SD) and WI (Han) rats from preclinical 2-year carcinogenicity studies

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.

March 19, 2023

Analysis of historical control locomotor activity data from vehicle control groups in adult rats

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.

March 19, 2023

Utilizing historical study data to reduce numbers of extra rodents ordered for nonclinical toxicology studies

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.

March 19, 2023

Neurobehavioral testing in mice: Positive control validation studies and historical control data

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.

March 20, 2023

Labcorp Drug Development enhanced vaccine delivery model

Labcorp Drug Development has been vested in helping pharmaceutical and biotechnology companies develop products to prevent and treat infectious diseases for more than 30 years, including providing support for well over 100 COVID-19-related projects.

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CROs and Sponsor relationships - review of responsibilities for successful study conduct and reporting

Optimizing Phase Ib with the right partner

Synthesis of radiolabelled crop protection products from carbon-14 building blocks

A global approach to determine hazardous physical properties

Expediting a pediatric vaccine trial through site- and participant-centric practices

Comparative analysis of historical control data in CD (SD) and WI (Han) rats from preclinical 2-year carcinogenicity studies

Analysis of historical control locomotor activity data from vehicle control groups in adult rats

Utilizing historical study data to reduce numbers of extra rodents ordered for nonclinical toxicology studies

Neurobehavioral testing in mice: Positive control validation studies and historical control data

Labcorp Drug Development enhanced vaccine delivery model