Industry representatives on the ICH S1B(R1) Expert Working Group (EWG) worked closely with colleagues from the Drug Regulatory Authorities to develop an addendum to the ICH S1B guideline on carcinogenicity studies that allows for a weight-of-evidence (WoE) carcinogenicity assessment in some cases, rather than conducting a 2-year rat carcinogenicity study. A subgroup of the EWG composed of regulators have published in this issue a detailed analysis of the Prospective Evaluation Study (PES) conducted under the auspices of the ICH S1B(R1) EWG. Based on the experience gained through the Prospective Evaluation Study (PES) process, industry members of the EWG have prepared the following commentary to aid sponsors in assessing the standard WoE factors, considering how novel investigative approaches may be used to support a WoE assessment, and preparing appropriate documentation of the WoE assessment for presentation to regulatory authorities. The commentary also reviews some of the implementation challenges sponsors must consider in developing a carcinogenicity assessment strategy. Finally, case examples drawn from previously marketed products are provided as a supplement to this commentary to provide additional examples of how WoE criteria may be applied. The information and opinions expressed in this commentary are aimed at increasing the quality of WoE assessments to ensure the successful implementation of this approach.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11153695 | PMC |
http://dx.doi.org/10.3389/ftox.2024.1377990 | DOI Listing |
JAMA Neurol
January 2025
Center for Health Decision Science, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
Invest Ophthalmol Vis Sci
January 2025
Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin, Italy.
Purpose: This study aimed to comprehensively assess visual performance in eyes with idiopathic epiretinal membrane (iERM). Additionally, it sought to explore the associations between optical coherence tomography (OCT) imaging biomarkers and visual performance in patients with iERM.
Methods: In this prospective, non-interventional study, 57 participants with treatment-naïve iERM from the University of Turin, between September 2023 and March 2024 were enrolled.
Anesth Analg
February 2025
SC Terapia Intensiva Neurochirurgica, Ospedale San Carlo Borromeo, ASST Santi Paolo e Carlo, Milano, Italy.
Background: Computed tomography (CT)-derived low muscle mass is associated with adverse outcomes in critically ill patients. Muscle ultrasound is a promising strategy for quantitating muscle mass. We evaluated the association between baseline ultrasound rectus femoris cross-sectional area (RF-CSA) and intensive care unit (ICU) mortality.
View Article and Find Full Text PDFJ Cardiovasc Transl Res
January 2025
Duke University Medical Center, Durham, NC, 27710, USA.
Background: Non-invasive, continuous blood pressure monitoring technologies require additional validation beyond standard cuff-based methods. This study evaluates a non-invasive, multiparametric wearable cuffless blood pressure (BP) diagnostic monitor across all hypertension classes with diverse subjects.
Methods: A prospective, multicenter study assessed Nanowear's SimpleSense-BP performance, including induced and natural BP changes, significant BP variations (Systolic BP (SBP) ≥ ± 15 mm Hg and Diastolic BP (DBP) ≥ ± 10 mm Hg), and reference input value validity over 4 weeks.
Eur Spine J
January 2025
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
Background: Intervertebral disc (IVD) degeneration is the main cause of neck pain. Although conventional magnetic resonance imaging can detect morphological changes in intervertebral disc degeneration, it cannot provide accurate and objective evaluations. Magnetic resonance diffusion tensor imaging (DTI) reflects the microstructural changes in tissues by describing the diffusion of water molecules.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!