Results 191 to 200 of about 11,470,422 (277)

Special Populations in Pivotal Clinical Trials: Eligibility and Supporting Evidence for Exclusion in EMA‐Authorised Medicines

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Evidence on the efficacy and safety of medicines supporting marketing authorization is largely derived from randomized controlled trials, yet these trials often exclude populations likely to use the medications in clinical practice. This study assessed eligibility of special populations, defined as pregnant and breast‐feeding individuals, elderly ...
Maja J. Jørgensen   +2 more
wiley   +1 more source

Overview of Regulatory Guidelines Related to Methods and Models for Small Populations

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
This paper provides an overview of approaches and related guidelines from the EMA, FDA, and ICH that are relevant for obtaining clinical evidence for small populations to support regulatory decision making. The approaches are grouped into three categories: (1) maximizing the attainable sample size, (2) adapting the trial design to deal with a small ...
Laurens Sluijterman   +6 more
wiley   +1 more source

Beyond the Human Negotiator: Generative AI and the Threshold of Autonomous Decision‐Making

open access: yesConflict Resolution Quarterly, EarlyView.
ABSTRACT This article provides a comprehensive framework for understanding the role of artificial intelligence (AI) in negotiation, evaluating contemporary systems through the specific case study of Large Language Models (LLMs). To address the lack of established terminology, it first proposes a new typology distinguishing Negotiation Supported by AI ...
Martin Svatos
wiley   +1 more source

CEO Overconfidence and Corporate Social Responsibility: A Micro‐CSR Perspective

open access: yesCorporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT Although research on micro‐level CSR has increasingly emphasized individual‐level antecedents, the role of CEO overconfidence has not been systematically integrated into the literature. To address this gap, a systematic literature review was undertaken of 62 studies on CEO overconfidence and CSR, revealing a mixed picture of positive, negative,
Jannis Kreinhop
wiley   +1 more source

The psychosocial impact of climate change: an umbrella review and meta-analysis. [PDF]

open access: yesFront Public Health
Leiva-Bianchi M   +4 more
europepmc   +1 more source

Harmonizing Social Impact Assessment in the Bioeconomy: A Cross‐Regional Fuzzy‐Delphi Approach

open access: yesCorporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT The bioeconomy transition risks underrepresenting social sustainability, while existing Social Life Cycle Assessment (S‐LCA) applications remain insufficient for comparison and decision support due to heterogeneous and non‐standardized selection of social impact categories. This study proposes a cross‐regional baseline set of impact categories
Julia Lessa Feitosa Virgolino   +2 more
wiley   +1 more source

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