Results 21 to 30 of about 1,892 (131)
Potency assays and biomarkers for cell-based advanced therapy medicinal products
Frontiers in Immunology, 2023 Advanced Therapy Medicinal Products (ATMPs) based on somatic cells expanded in vitro, with or without genetic modification, is a rapidly growing area of drug development, even more so following the marketing approval of several such products.
Chiara Capelli +22 more
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Advanced therapy medicinal products in China: Regulation and development
MedComm, 2023 Advanced therapy medicinal products (ATMPs) have shown dramatic efficacy in addressing serious diseases over the past decade. With the acceleration and deepening of China's drug regulatory reforms, the country sees a continuous introduction of policies ...
Jiaqi Lu, Longchang Xu, Wei Wei, Wu He
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Frontiers in Pharmacology, 2021 Even for centrally approved products, each European country is responsible for the effective national market access. This step can result in inequalities in terms of access, due to different opinions about the therapeutic value assessed by health ...
Lucia Gozzo +9 more
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Frontiers in Medicine, 2021 This paper presents the results of a qualitative study based on semi-structured interviews of 10 expert patient advocates on several different issues around Advanced Therapy Medicinal Products (ATMPs).
Stefano Benvenuti +3 more
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Defining core competencies for advanced therapy medicinal products translation. [PDF]
Front Digit HealthBackgroundTranslating Advanced Therapy Medicinal Products (ATMPs) from research to clinical application requires a specialized set of priority topic areas that is not yet systematically defined.MethodsWe employed a multi-phase approach combining a ...
Guillen E, Hidalgo-Simon A.
europepmc +2 more sources
2023, A Landmark Year in Biomedical Research; A Turning Point in Medical History [PDF]
Cell JournalThe rapid development of knowledge on healthy nutrition, and hygiene practices, as well as the advent of antibioticsand vaccines, has led to increased life expectancy in the recent century.
Bahareh Sadri, Massoud Vosough
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Is the Conjunctiva a Potential Target for Advanced Therapy Medicinal Products?
Pharmaceutics, 2021 The conjunctiva is a complex ocular tissue that provides mechanical, sensory, and immune protection for the ocular surface. It is affected by many diseases through different pathological mechanisms.
Yolanda Diebold, Laura García-Posadas
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Advanced Therapy Medicinal Products (ATMPs): fundamental concepts, classification, and translational challenges [PDF]
Exploration of Drug ScienceAdvanced Therapy Medicinal Products (ATMPs) represent a transformative class of innovative therapies based on genes, cells, or engineered tissues that aim to modify, repair, or replace biological functions at a fundamental level.
Alfi Sophian +3 more
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Frontiers in Medicine, 2017 In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs).
Andreas M. Farkas +8 more
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Cell-based medicinal products approved in the European Union: current evidence and perspectives
Frontiers in Pharmacology, 2023 Advanced Therapy Medicinal Products (ATMPs) are innovative clinical treatments exploiting the pharmacological, immunological, or metabolic properties of cells and/or gene(s) with the aim to restore, correct, or modify a biological function in the ...
Stefania Bellino +3 more
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