Improving the safety pharmacology standard: CNS behavioural investigations using anticholinergics as a comparator against the standard Irwin test

SPS 2024 -- The ICH S7A safety pharmacology guidelines require a novel test article to be assessed for central nervous system (CNS) effects as a part of the core battery. Although follow-up behavioral studies are advised, these are rarely seen as part of the GLP safety pharmacology package of work, with an Irwin screen alone conducted to address this requirement. Anticholinergics are a type of drug that block acetylcholine (Ach), a neurotransmitter at synapses in the central and peripheral nervous system.

Labcorp to Announce Third Quarter Financial Results on October 24, 2024

BURLINGTON, N.C. , Sept. 24, 2024 /PRNewswire/ -- Labcorp  (NYSE: LH), a global leader of innovative and comprehensive laboratory services, will release its financial results for the third quarter of 2024 before the market opens on Thursday, October 24, 2024 .

Labcorp Biopharaceutical CMC Services: Antibody drug-conjugates (ADCs) Analytical considerations for QC release, stability testing, characterization and comparability

The importance of the cynomolgus macaque’s origin in drug safety assessment

Cynomolgus macaques are the most commonly used non-human primate species for drug safety assessment. However, recent supply shortages  have brought increased attention to the genetic differences between cynomolgus macaques of varying geographic origins. It is important to examine the relevance of geographic origin for cynomolgus macaques used in regulatory toxicology studies.

Key learnings from ECHA's review of the EOGRTS (OECD Test Guideline 443)

The extended one-generation reproductive toxicity study (EOGRTS) per OECD Test Guideline 443 is a crucial test for evaluating potential reproductive and developmental effects of chemicals. Recently, the European Chemicals Agency (ECHA) conducted an extensive review of EOGRTS  studies to assess the effectiveness of this test guideline and provide recommendations for improvement. This blog post summarizes  key learnings from ECHA's review and the impacts on current and future EOGRTS study design.

The three lab stewardship utilization rights: Underutilization in focus

Laboratory testing is critically important to a person’s healthcare journey. In fact, lab test results inform 70% of medical decisions despite only accounting for less than 3% of healthcare spending.However, with the great power of the lab, comes great fiscal responsibility. In this article, Todd Berman, payor solutions director of stewardship strategies at Labcorp, outlines the three lab stewardship rights, with an in-depth look at underutilization.

Nonclinical study in juvenile cynomolgus monkeys for a postmarketing requirement from FDA for gadolinium-based contrast agents

ETS 2024 -- In December 2017, the U.S. Food and Drug Administration (FDA) requested the four gadolinium-based contrast agent (GBCA) NDA holders to further investigate the effects of gadolinium (Gd) retention on fetal and neonatal development in mice and juvenile nonhuman primates (NHP) to evaluate the potential effect of GBCAs on behavioral, neurological and histopathological changes. The studies performed in mice have been previously presented and the results of the NHP study are presented here.

Assessment of the correlation of the infant body weight with maternal body weight development in the cynomolgus monkey (Macaca fascicularis) in the context of DART evaluation

ETS 2024 -- Developmental and reproductive toxicity (DART) studies are required by regulatory agencies such as the U.S. Food and Drug Administration (FDA) for drugs to be used by women of childbearing age or men of reproductive potential. The enhanced pre- and postnatal developmental (ePPND) study design with pregnant nonhuman primates (NHPs) is the predominant default DART study type since the release of ICH S6(R1). Infant growth is a key parameter in developmental toxicity testing in addition to pregnancy outcome in ePPND studies. Growth development is usually evaluated via the assessment of several endpoints such as body weight and length. This work explores whether there is a correlation between infant and maternal body weight development.