| Labcorp

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.

April 1, 2023

Now Offering Droplet Digital PCR (ddPCR) and NanoString nCounter

Labcorp now offers ddPCR services to allow nucleic acid quantification with ultrasensitivity and high precision using Bio-Rad's QX200 System, as well as NanoString nCounter services providing off-the-shelf and custom panels to inform how a drug modulates gene expression and signaling pathways.

April 3, 2023

Second generation mRNA vaccines: Formulation development of mRNA-lipid nanoparticles with TLR9 agonist CpG oligonucleotide adjuvant

WVC 2023 -- Messenger RNA (mRNA) vaccines have attracted increasing attention as a promising and adaptable alternative to conventional vaccine modalities. mRNA vaccine efficacy relies on the vaccine's ability to the reach the cytoplasm of the target cells in high quantities where it can be translated into the antigen of interest.

<span>Environmental Risk Assessment for Pharmaceutical Drugs: Understanding the Evaluation and Implications of Findings to the Regulatory Review of Human Medicines in the Environment</span>

April 6, 2023

Environmental Risk Assessment for Pharmaceutical Drugs: Understanding the Evaluation and Implications of Findings to the Regulatory Review of Human Medicines in the Environment

Pharmaceutical drugs are intended for the treatment of human disease, therefore the risk of their environmental exposure in clinical use needs to be evaluated. Environmental risk assessment (ERA) is part of the requirements when applying for marketing approval in many geographic regions throughout the world.

April 7, 2023

20 critical questions: Helping you optimize reference standards for your biopharmaceutical across its development life cycle

This white paper explores challenges in understanding, identifying and managing reference standards for biopharmaceuticals. Their characterization is more nuanced than is the case for standards for small molecules.

April 7, 2023

mRNA-lipid nanoparticles: Quality control releasing testing and characterization

The regulatory authorizations and approvals of the Pfizer and Moderna COVID-19 vaccines proved to be a trailblazer for the mRNA-LNP modality and opened the pathway for regulatory approvals of a whole raft of similar mRNA-based products.

April 13, 2023

United partnerships deliver for the client in a complex NASH study

An internal operations pilot at Labcorp Drug Development is serving as an "Innovation Incubator" to launch new ways of working across its clinical and laboratory service teams to solve important issues that can impact the client and patients during a clinical trial.

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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

Now Offering Droplet Digital PCR (ddPCR) and NanoString nCounter

Second generation mRNA vaccines: Formulation development of mRNA-lipid nanoparticles with TLR9 agonist CpG oligonucleotide adjuvant

Environmental Risk Assessment for Pharmaceutical Drugs: Understanding the Evaluation and Implications of Findings to the Regulatory Review of Human Medicines in the Environment

20 critical questions: Helping you optimize reference standards for your biopharmaceutical across its development life cycle

mRNA-lipid nanoparticles: Quality control releasing testing and characterization

United partnerships deliver for the client in a complex NASH study