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.

STP 2024 -- Expression of proteins/mRNAs can be quantitated semi-quantitatively using a microscope or digitized images for biomarker studies.

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.

UKEMS 2024 -- Labcorp has been performing the Transgenic Rodent Somatic and Germ Cell Gene Mutation Assay (OECD TG 488) in the MutaMouse model for over 25 years and has significant experience in a wide variety of somatic tissues and germ cells. Labcorp employs different DNA extraction techniques according to tissue type.