Results 231 to 240 of about 1,719,001 (314)

Driving continuous improvement of sustainability certification for industrial biobased systems through comprehensive sustainability requirements

open access: yesBiofuels, Bioproducts and Biorefining, EarlyView.
Abstract Existing monitoring frameworks for sustainability certification schemes and labels (CSLs) have largely prioritised environmental aspects, while the social and economic pillars of sustainability remain comparatively underdeveloped. Also, dedicated circularity requirements tailored to biobased systems are still largely lacking, despite being ...
Iris Vural Gursel   +5 more
wiley   +1 more source

Metabolic fate of drugs of abuse and new psychoactive substances: A pilot study on a novel workflow using a zebrafish embryo model combined with human microdosing

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The aim of this study was to develop a novel workflow to identify human urine biomarkers for drugs of abuse and new psychoactive substances. Metabolites of amphetamine, cocaine, LSD, MDMA, methamphetamine, THC, MDMB‐CHMICA, and MDPPP were first identified in a zebrafish embryo (ZE) metabolism study followed by comparison to most abundant human ...
Simon K. Wellenberg   +7 more
wiley   +1 more source

Trends in 25 years of antihypertensive agent utilization in Croatia – an alert for scientific community and healthcare providers

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Hypertension is a leading modifiable risk factor for cardiovascular mortality worldwide. This study aimed to evaluate 25‐year trends in antihypertensive agent (AHA) utilization in Croatia between 2000 and 2024. Methods We conducted a national, population‐based analysis using IMS and IQVIA pharmaceutical databases.
Andrej Belančić   +4 more
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

Zuranolone: A case study in (regulatory) rush to judgement?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove   +4 more
wiley   +1 more source

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