Can in silico models predict drug-induced cardiac risk in vulnerable populations?
By Paula Dominguez-Gomez et al.
This study evaluates virtual cardiac populations for preclinical assessment of drug-induced QT interval prolongation and arrhythmic risk. A virtual cohort of subjects across healthy and diseased hearts was generated using computational models of realistic heart anatomies and electrophysiology. They then assessed QT prolongation and arrhythmic events following drug administration.
Retrospective evaluation of the use of non-human primates for fertility assessment of pharmaceuticals submitted for marketing approval in the EU.
By Puck Roos et al.
The authors evaluated fertility assessment in non-human primates for human pharmaceuticals. They found that non-human primate data were not vital for fertility risk assessment : For small molecules, rodent data provided sufficient information; for biologicals, effects were related to their mechanism of action. no clear scientific value of fertility assessment in sexually mature NHP was determined.
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
By the FDA
This guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. Specifically, this guidance provides a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU).
ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials
By the MEA
The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding individuals in clinical trials and facilitate the generation of robust clinical data that allow for evidence-based decision making on the safe and effective use of medicinal products by these individuals and their healthcare providers (HCPs).
Incorporating new approach methodologies in the development of new medicines
By the NC3Rs and the MHRA
To explore how New Approach Methodologies (NAMs) can be more effectively integrated into medicines development, the NC3Rs, MHRA and ABPI convened a cross-sector workshop with experts from regulatory agencies, industry and academia. Discussions focused on identifying where NAMs are currently being used, the scientific and regulatory challenges to broader adoption, and practical steps that could support progress.
FDA Moves to Limit Certain Long-Term Non-Human Primate Studies
By Soumya Shashikumar
The FDA has released draft guidance outlining when six-month toxicity studies in non-human primates may be reduced or eliminated for certain monoclonal antibody programs. The update shifts how the agency evaluates nonclinical safety packages for biologics, placing greater emphasis on human-relevant data rather than default long-duration primate studies.
Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
By the FDA
The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. It also provides interpretations of terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors.
Cleaning the scientific house: Rebuilding trust in science requires confronting the harms of ghostwriting
By Naomi Oreskes
In this article, the author explains how ghost-writing in science threatens the integrity of scientific research. She takes the example of a paper about the safety of the pesticide glyphosate that happened to be written by Monsanto employees, and that is cited as a “reliable and credible source” proving that glyphosate is non-carcinogenic in many academic papers and government documents.
Study of Sex Differences in the Clinical Evaluation of Medical Products
By the FDA
This guidance provides recommendations for increasing enrollment of female participants in clinical trials and non-interventional studies to help ensure the generalizability of results, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. The general principles outlined in this guidance also apply to increasing enrollment of male participants in clinical trials if underrepresented.