Articles with "regulatory requirements" as a keyword



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Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach methodologies

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Published in 2021 at "Archives of Toxicology"

DOI: 10.1007/s00204-021-03034-y

Abstract: The EU Directive 2010/63/EU on the protection of animals used for scientific purposes and other EU regulations, such as REACH and the Cosmetic Products Regulation advocate for a change in the way toxicity testing is… read more here.

Keywords: assessment chemicals; toxicity; regulatory requirements; current regulatory ... See more keywords
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Optimal capital, regulatory requirements and bank performance in times of crisis: Evidence from France

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Published in 2018 at "Journal of Financial Stability"

DOI: 10.1016/j.jfs.2017.03.002

Abstract: The recent implementation of the Basel III framework has re-ignited the debate around the link between capital, performance and capital requirements in the banking sector. There is a dominant view in the earlier empirical literature… read more here.

Keywords: capital; evidence; regulatory requirements; performance ... See more keywords
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Challenges of regulatory requirements for patient registries in different countries

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Published in 2019 at "Molecular Genetics and Metabolism"

DOI: 10.1016/j.ymgme.2018.12.188

Abstract: The International Niemann-Pick Disease Registry (INPDR) is a single, rare disease-specific registry collating global Niemann-Pick Disease data. Created by professionals and patients for worldwide use, it collects clinical and patient reported data with separate datasets… read more here.

Keywords: regulatory requirements; registry; challenges regulatory; human research ... See more keywords
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An updated review on food-derived bioactive peptides: Focus on the regulatory requirements, safety, and bioavailability.

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Published in 2022 at "Comprehensive reviews in food science and food safety"

DOI: 10.1111/1541-4337.12911

Abstract: Food-derived bioactive peptides (BAPs) are recently utilized as functional food raw materials owing to their potential health benefits. Although there is a huge amount of scientific research about BAPs' identification, purification, characterization, and physiological functions,… read more here.

Keywords: safety; regulatory requirements; food; derived bioactive ... See more keywords

Regulatory requirements and labeling of commercially available prescription (oral) medicines in Sri Lanka: there is room for improvement

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Published in 2022 at "Journal of Pharmaceutical Policy and Practice"

DOI: 10.1186/s40545-022-00409-z

Abstract: Background The consistency and the quality of medicine labels are sought through the regulatory frameworks. This study aims at investigating the secondary labels of medicines based on the labeling regulations and guidelines issued by the… read more here.

Keywords: sri lanka; prescription oral; medicine; regulatory requirements ... See more keywords
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Method of determining the regulatory requirements for the technological stages` accuracy in topographic aerial photography

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Published in 2023 at "Geodesy and Cartography"

DOI: 10.22389/0016-7126-2023-992-2-29-43

Abstract: Introduction of BIM-modeling methodology and geoinformation technologies in the construction industry causes the need of taking into account the specific customer requirements for the accuracy of building 3D-models in engineering-geodetic surveys. The author analyzes the… read more here.

Keywords: technological stages; regulatory requirements; method determining; requirements technological ... See more keywords
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Regulatory Requirements for Exporting Cosmetic Products to Extra-EU Countries

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Published in 2023 at "Cosmetics"

DOI: 10.3390/cosmetics10020062

Abstract: In this study, an overview of the regulations in force in some extra-EU states belonging to different geoeconomic areas is provided, starting from the current EU legislation on cosmetic products. We focused on their legislative… read more here.

Keywords: regulatory requirements; extra countries; exporting cosmetic; cosmetic products ... See more keywords
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Robotics and Aseptic Processing in View of Regulatory Requirements

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Published in 2023 at "Pharmaceutics"

DOI: 10.3390/pharmaceutics15061581

Abstract: Several nanomedicine based medicinal products recently reached the market thanks to the drive of the COVID-19 pandemic. These products are characterized by criticality in scalability and reproducibility of the batches, and the manufacturing processes are… read more here.

Keywords: aseptic processing; regulatory requirements; robotics; robotics aseptic ... See more keywords
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Regulatory requirements for clinical trials in India: What academicians need to know

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Published in 2017 at "Indian Journal of Anaesthesia"

DOI: 10.4103/ija.ija_143_17

Abstract: The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians… read more here.

Keywords: research; requirements clinical; regulatory requirements; india academicians ... See more keywords