Introducing Labcorp Global Trial Connect. Complementary digital, data and operational solutions to enable sites to spend more time with their patients, get studies started faster, maintain study momentum and increase study throughput.
Minimize delays by tightly controlling this pre-submission timeline. Talk to your chosen eCA early on to arrange a pre-submission meeting; some eCAs are open to receiving final long-term stability data after submission if this is agreed before submission, significantly shortening the timeline.
STP 2024 -- Historically, the use of two-year rodent (CD-1� mouse and Sprague Dawley� or Wistar Han� rat) studies has been the standard practice to assess the carcinogenic potential of pharmaceuticals.
STP 2024 -- Carcinogenicity studies are important in identifying tumorigenic potential in animals as part of the risk assessment for new drugs. Historical control incidences are important considerations when interpreting data and useful when selecting and assessing the suitability of an animal model.
STP 2024 -- Compounded formulations of buprenorphine HCl extended-release polymer injection solution (BUP-ER) offer convenient, long-acting pain control for laboratory animals. Several long-acting buprenorphine formulations have recently been reported to cause significant injection site reactions in nonhuman primates and rodents.
While designing a qPCR/ddPCR assay for supporting cell and gene therapies can be straight forward, there are also key challenges and complexities molecular bioanalytical scientists currently face in the process.
LIVe 2024 -- This study was initiated to investigate a continuous flow gaseous exposure system to three gaseous compounds. There is a current push to investigate products in a more physiologically relevant environment (continuous flow versus static). 3D airway tissue models are a relevant method for analysis of toxicity for these gaseous products.
UKEMS 2024 -- The in vitro micronucleus (IVMN) test was endorsed for regulatory genotoxicity testing with the adoption of OECD test guideline (TG) 487 in 2010, updated in 2016 and corrected on 04 July 2023. This guideline includes recommendations for treatment of p53 competent human lymphocytes.
UKEMS 2024 -- Enhanced testing conditions for the Bacterial Reverse Mutation (Ames) assay, using 30% rat or hamster liver S-9 mix, are recommended due to the reported reduced assay sensitivity under standard assay conditions for some N-nitrosamines.
