Results 211 to 220 of about 86,068 (316)

Beyond the Outburst: Charting a New Frontier for Understanding and Treating Irritability in Autistic Adults

open access: yesAutism Research, EarlyView.
ABSTRACT Irritability is a prevalent and impairing feature associated with autism, yet remains poorly understood, particularly in adults. Drawing heavily on insights translated from pediatric and transdiagnostic literatures, we propose that irritability in autistic individuals often reflects a psychophysiological stress or threat response, rooted in a ...
Hsiang‐Yuan Lin   +3 more
wiley   +1 more source

Operationalizing BioSSbD: A safe‐and‐sustainable‐by‐design framework for biorefineries

open access: yesBiofuels, Bioproducts and Biorefining, EarlyView.
Abstract Biorefineries are central to the transition toward a circular bioeconomy; however, their increasing scale and technological heterogeneity, and the integration of biological, chemical, and thermochemical processes introduce complex challenges related to safety, sustainability, and operational reliability. Existing Safe‐and‐Sustainable‐by‐Design
Fernando Ramonet
wiley   +1 more source

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

Early clinical pharmacology evaluation of the novel anti‐inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims This work assessed the pharmacokinetics (PK), safety and tolerability of glasmacinal (EP395, an oral anti‐inflammatory macrolide with negligible antimicrobial activity in development for COPD treatment) in two healthy participant trials: ‘first‐in‐human’ (FIH) and ‘drug–drug‐interaction’ (DDI).
Dave Singh   +5 more
wiley   +1 more source

Quality indicators for safe and effective medication use in long‐term care facilities: A modified Delphi study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim This modified Delphi study aimed to achieve expert agreement on quality indicators (QIs) suitable for application at the population level, to evaluate quality use of medications and pharmacist services in long‐term care facilities (LTCFs). Methods We conducted a two‐round modified online Delphi study with a multidisciplinary panel of Australian ...
Daria S. Gutteridge   +10 more
wiley   +1 more source

Measurement invariance of the Personality Inventory for DSM-5 across sex. [PDF]

open access: yesFront Psychiatry
Rivard G   +3 more
europepmc   +1 more source

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