Results 151 to 160 of about 3,929 (267)

International Accouting - Accounting Regulation and Diversity

open access: yes, 2004
Accounting harmonisation is a very actual topic on the financial reporting agenda, both in practice and in academics due to the new EU requirements for public companies financial reporting, as from 2005.
Lundh, Simon,, Fagerström, Arne,
core  

Global Pharmaceutical Regulation: Comparative Frameworks and Operations. [PDF]

open access: yesPharmacy (Basel)
Umaru OT   +6 more
europepmc   +1 more source

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

The <sup>68</sup>Ge/<sup>68</sup>Ga generator for enhancing productivity and reducing costs in nuclear medicine: experience from a university hospital. [PDF]

open access: yesEJNMMI Radiopharm Chem
Guercio A   +7 more
europepmc   +1 more source

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden   +3 more
wiley   +1 more source

A dose‐finding population pharmacokinetic/pharmacodynamic model of ginisortamab, an anti‐gremlin‐1 monoclonal antibody, in patients with solid tumours

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Ginisortamab, a first‐in‐class human monoclonal antibody for the treatment of advanced solid tumours, binds to gremlin‐1 and restores bone morphogenetic protein signalling. We used pharmacokinetic/pharmacodynamic (PK/PD) modelling to characterize the relationship between ginisortamab dose and serum gremlin‐1 binding, using model‐based simulations ...
Yin Cheong Wong   +6 more
wiley   +1 more source

Clinical Pharmacokinetics, Mass Balance and Metabolism of Fezolinetant in Postmenopausal Women. [PDF]

open access: yesEur J Drug Metab Pharmacokinet
Iwai M   +8 more
europepmc   +1 more source

Optimal dosing for vascular anomalies paediatric patients with population pharmacokinetic model of sirolimus

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Sirolimus is currently used off‐label for paediatric patients with vascular anomalies. However, the optimal dosage regimen for paediatric patients remains controversial. This study aimed to determine the optimal dosing regimen of sirolimus in these patients using a population pharmacokinetic (PK) model.
Seongmee Jeong   +13 more
wiley   +1 more source

Building trust in the integration of artificial intelligence into chemical risk assessment: findings from the 2024 ECETOC workshop. [PDF]

open access: yesArch Toxicol
Gant TW   +22 more
europepmc   +1 more source

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