The need for guidance in antidepressant drug development: Revisiting the role of the forced swim test and tail suspension test

Regulatory Toxicology and Pharmacology, Journal Year: 2024, Volume and Issue: 151, P. 105666 - 105666

Published: June 27, 2024

Depressive disorders are one of the most common mental globally and progress in treating these has been hampered, part, by a lack suitable nonclinical efficacy tests. Two tests used studies antidepressants-the forced swim test (FST) tail suspension (TST)-have come under criticism recent years for their inconsistency validity, yet they continue to be pharmaceutical industry. In this review, we provide rationale why international regulatory guidance agencies should begin issuing direction on methods non-clinical testing that traditionally use FST TST, particularly considering some regulators, such as those U.S. E.U., allow authorization clinical trials proceed without requiring animals. The area antidepressant drug discovery represents an important opportunity reducing attrition psychiatric drugs, harmonizing requirements, animal use. Specific recommendations International Council Harmonisation Technical Requirements Pharmaceuticals Human Use (ICH) have provided.

Language: Английский

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Examining animal testing for risk assessment: A WC-12 workshop report

Regulatory Toxicology and Pharmacology, Journal Year: 2024, Volume and Issue: 147, P. 105564 - 105564

Published: Jan. 4, 2024

In toxicology and regulatory testing, the use of animal methods has been both a cornerstone subject intense debate. To continue this discourse panel audience representing scientists from various sectors countries convened at workshop held during 12th World Congress on Alternatives Animal Use in Life Sciences (WC-12). The ensuing discussion focused scientific ethical considerations surrounding necessity responsibility defending creation new data testing. primary aim was to foster an open dialogue between members while encouraging diverse perspectives responsibilities obligations stakeholders (including industry, bodies, technology developers, research scientists, welfare NGOs) development subsequent utilization data. This summary report captures key elements critical collective introspection. It describes intersection progress as all seek accelerate pace 21st century predictive approach methodologies (NAMs) for protection human health environment.

Language: Английский

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Relevance and feasibility of principles for health and environmental risk decision-making

Journal of Toxicology and Environmental Health Part B, Journal Year: 2024, Volume and Issue: 27(5-6), P. 189 - 211

Published: May 14, 2024

Globally, national regulatory authorities are both responsible and accountable for health environmental decisions related to diverse products risk decision contexts. These provided oversight expedited market authorizations of vaccines other therapeutic during the COVID-19 pandemic. Regulatory regarding such situations depend upon well-established assessment management steps. The underlying processes supporting were outlined in frameworks describing complex interactions between factors including steps as well principles which help guide decision-making. In 2022, experts science proposed a set 10 guiding principles, further examining intersection utility these using contexts, inviting broader discourse on application To add this information, Canadian practitioners evaluating risks establishing policies convened at Health Canada workshop Principles Risk Decision-Making. This review reports results derived from interactive engagement provides first pragmatic analysis relevance, importance, feasibility decision-making within context.

Language: Английский

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Ethical principles for regulatory risk decision-making

Regulatory Toxicology and Pharmacology, Journal Year: 2025, Volume and Issue: unknown, P. 105813 - 105813

Published: March 1, 2025

Risk assessors, managers, and decision-makers are responsible for evaluating diverse human, environmental, animal health risks. Although the critical elements of risk assessment management well-described in national international documents, ethical issues involved decision-making have received comparatively little attention to date. To address this aspect, article elaborates fundamental principles designed support fair, balanced, equitable risk-based practices. Experts global thinkers risk, health, regulatory, sciences were convened share their lived experiences relation intersection between science analysis, regulatory science, public health. Through a participatory knowledge translation approach, an integrated model, with considerations, was developed applied using diverse, contemporary contexts. The ten - autonomy, minimize harm, maintain respect trust, adaptability, reduce disparities, holistic, fair just, open transparent, stakeholder engagement, One Health lens demonstrate how sector values moral norms (i.e., ethics) relevant decision-making. We also hope these considerations stimulate further discussion, debate, increased awareness application ethics identifying, assessing, managing

Language: Английский

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Key attributes of health and environmental risk decision‐making: A scoping review

Risk Analysis, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 2, 2025

Abstract Government agencies, international institutions, and independent experts have published approaches for the assessment management of health environmental risks. This includes evidence‐based strategies publications supporting risk decision‐making frameworks reflecting contemporary practices, overarching context, governance structures addressing known emerging issues. scoping review surveys literature, over last five decades, to identify key attributes how these inherent characteristics are related regulatory context. The findings provide insights on accounted circumstances triggers at that time. incorporating factors advances in science technology, a better understanding underlying values (e.g., societal), an expansion scope complexity required conducting different evaluations relevant Consequently, evolution from linear more expanded holistic incorporates foundational elements, such as well‐established steps assessing risks, while adding aspects transformative changes paradigm shifts use non‐animal testing evaluating human safety). Our analysis also resulted generation consolidated listing ten attributes: trigger/issue, factors, core values, principles, cross‐cutting attributes, design (scope steps), structure, pathway, evidence‐knowledge requirements decision‐making. A this will be used future work aimed developing considerations next

Language: Английский

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Report of the European Commission Workshop on “The Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments”, Brussels, 11-12 December 2023

Regulatory Toxicology and Pharmacology, Journal Year: 2025, Volume and Issue: unknown, P. 105818 - 105818

Published: April 1, 2025

Language: Английский

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New approach methods in chemicals safety decision-making – Are we on the brink of transformative policy-making and regulatory change?

Computational Toxicology, Journal Year: 2024, Volume and Issue: 30, P. 100310 - 100310

Published: April 4, 2024

Language: Английский

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Machine learning-based prediction of fish acute mortality: implementation, interpretation, and regulatory relevance

Environmental Science Advances, Journal Year: 2024, Volume and Issue: 3(8), P. 1124 - 1138

Published: Jan. 1, 2024

The study focuses on the implementation and interpretation of four state-of-the-art machine learning methods coupled with six molecular representations to predict fish acute mortality.

Language: Английский

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Progress and Remaining Opportunities to Increase the Use of Animal-free Antibodies in the USA

Alternatives to Laboratory Animals, Journal Year: 2024, Volume and Issue: 52(5), P. 285 - 289

Published: July 24, 2024

The scientific and ethical issues associated with the use of animal-derived antibodies in research can be overcome by animal-free, sequence-defined recombinant antibodies, whose benefits are well documented. Here, we describe progress made following a 2019 expert meeting focused on improving quality reproducibility biomedical accelerating production animal-free USA. In five intervening years since meeting, participants have established multifaceted initiatives to tackle next steps outlined during meeting. These include: prioritising replacement ascites-derived polyclonal antibodies; distributing educational materials describing fostering public-private partnerships increase access increasing availability funding for antibody development. Given widescale across disciplines, transition modern methods relies commitment from government agencies, universities, industry organisations, such as those here.

Language: Английский

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Evidence-Based Social Sciences and Practices: A Scoping Review

Journal of language and Education, Journal Year: 2024, Volume and Issue: 10(2), P. 5 - 31

Published: June 16, 2024

Introduction: The evidence-based medicine (EBM) was introduced in the 1990s, paving way for new approaches to science methodology and research evidence that changed medicine-related practices. Following EBM, social sciences ranging from education public governance policymaking entered a stage of knowledge production dissemination. Each field produces its own synthesis laying foundation efficient Pilot searches failed bring complex complete sciences. Purpose: This scoping review aims identify scope practices as an emerging field. Method: adhered PRISMA extension reviews, PPC framework. eligibility criteria include problem (population), concept, context, language, time period, types sources, geographical location, databases, areas research. relevant publications entail Scopus database. studies were identified selected by screening titles, abstracts full texts, totalling 35 documents. Results: results cover search selection outcomes; bibliometric analysis, breakdown among four thematic clusters; findings relating practice applicable sciences; analysis area practices; sectors. Much EBM directly borrowed Though, major controversy found hierarchy levels are subject human choices. Randomized controlled trials systematic reviews analysed context most elaborated fast developing contained policymaking, with systems governmental agencies institutions introducing these Сonclusion. attained objective gave answers questions. Only few published comprehensively address Fragmentated sub-fields covered unevenly, many mythological divergences disputed issues, including quality evidence, their weight hierarchy,

Language: Английский

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