Results 21 to 30 of about 7,238,985 (145)
Advanced Therapy Medicinal Products in Vitiligo; Current Status, Future Prospect, and Approved Treatments [PDF]
Cell Journal, 2023 Vitiligo is an auto-immune disease, causing depigmentation of skin in 0.2-1.8% of global population. Topicalcorticosteroids and calcineurin inhibitors are the only treatments with firm evidence of optimal effectiveness withconsiderable side effects ...
Shahriar Ghashghaei +5 more
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Advanced Therapy Medicinal Products
, 2023 125In recent years advances in biology, biotechnology, and medical research have led to a new category of biologicals – the advanced therapy medicinal products (ATMPs).
Dehmel, Susann +2 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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Molecular Therapy: Methods & Clinical Development, 2019 Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency’s Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission.
Giulia Detela, Anthony Lodge
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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 Pharmacology, 2012 The market authorisation procedure for medicinal products for human use is relying on their demonstrated efficacy, safety and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the
Philippe eVan Wilder
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, 2022 International audienceThe question of comparability for Advanced Therapy Medicinal Products (ATMPs) is very often asked during Scientific Advice Meetings at the European Medicines Agency.
Morrison, Michael +5 more
core +5 more sources
Pharmaceutics, 2022 Advanced therapy medicinal products (ATMPs) are medicines for human use based on genes, cells or tissue engineering. After clear successes in adults, the nascent technology now sees increasing pediatric application.
Carsten W. Lederer +8 more
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Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States
Frontiers in Pharmacology, 2019 Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development.
Carolina Iglesias-Lopez +5 more
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Towards novel reimbursement models for expensive advanced therapy medicinal products (ATMPs)
Swiss Medical Weekly, 2020 Currently, a major focus of biomedical research and clinical application are the so-called advanced therapy medicinal products (ATMPs), which are highly complex medicines that enable the targeted and personalised treatment of patients. The potential of
Dario Picecchi +3 more
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