Results 81 to 90 of about 37,828 (267)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola   +5 more
wiley   +1 more source

Mapping opioid exposure through prescription data and postmortem analysis of opioid drugs in multiple tissues

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Background and Purpose Although opioids are central to end of life (EoL) care, tissue‐level opioid exposure remains poorly understood. The objective of this study was to characterize the relationship between prescription‐derived morphine equivalent daily dose (MEDD) and measured morphine concentrations across multiple organs.
Niamh Higgins   +23 more
wiley   +1 more source

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan   +11 more
wiley   +1 more source

The role of agency costs and shareholder protection in family firms’ cash-holding decisions [PDF]

open access: yesJournal of Economics Finance and Administrative Science
PurposeThis study analyzes the effects of country-level shareholder protection and agency costs on the cash-holding policies of family firms.Design/methodology/approachData were collected for 2,159 European firms for the period 2010–2019.
Serhat Yaman, M. Belén Lozano
doaj   +1 more source

First‐in‐human, phase I, randomized, safety, pharmacokinetic, food‐effect and pharmacodynamic study of a tyrosine kinase 2/Janus kinase 1 inhibitor, SDC‐1801

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), food‐effect (FE) and pharmacodynamics (PD) of an oral tyrosine kinase‐2 (TYK2)/Janus kinase‐1 (JAK1) inhibitor, SDC‐1801, in healthy adult participants. Methods This first‐in‐human study randomized 95 male and female participants.
Chris Brearley   +3 more
wiley   +1 more source

Brain Health Deviation Index: A Comprehensive Brain Health Assessment Biomarker for Predicting Cognitive Decline and Polyvascular Stenosis

open access: yesBrain Health, EarlyView.
ABSTRACT Assessing and quantifying brain health remains a pressing challenge, despite its importance for overall well‐being. Traditional methods that focus on isolated brain measures often fail to capture the multifaceted nature of brain health and may miss early signs of dysfunction.
Ziyang Liu   +27 more
wiley   +1 more source

National Environmental Policies and Corporate Green Innovation: The Mirroring Versus Substitution Hypotheses

open access: yesBusiness Strategy and the Environment, EarlyView.
ABSTRACT Drawing on comparative institutional theory, we study the nature and magnitude of the effects of national environmental policies on corporate green innovation in developed versus emerging markets. Using a sample of 1831 listed firms in 34 countries from 2002 to 2020, we find that national environmental policies increase corporate green ...
Ivan Miroshnychenko   +2 more
wiley   +1 more source

Media Attention to Climate Change and Investor Flows in US Equity Mutual Funds

open access: yesBusiness Strategy and the Environment, EarlyView.
ABSTRACT This paper investigates how climate‐related news influences mutual fund investor behaviour in the United States. Although prior research has documented the financial relevance of climate risks, little is known about how media attention to climate change shapes capital allocation across mutual funds.
Laura Andreu   +3 more
wiley   +1 more source

Platform Business Model Innovation for Sustainability: A Framework for Industry 5.0 Integration

open access: yesBusiness Strategy and the Environment, EarlyView.
ABSTRACT A comprehensive framework is developed for adopting Platform Business Model Innovation (PBMI) to enhance sustainable performance in the Industry 5.0 (I5.0) era. While PBMI plays a growing role in corporate transformation, tensions persist between profit‐driven objectives and broader sustainability imperatives.
Mohamed Ashmel Mohamed Hashim   +3 more
wiley   +1 more source

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