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The clinical toxicity of advanced therapy medicinal products

British Journal of Clinical Pharmacology
AimsAdvanced Therapy Medicinal Products (ATMPs) use genes, tissues or cells to offer transformative treatments for a range of diseases. They are associated with different safety challenges when compared to established therapeutics, such as small chemical entities or monoclonal antibodies, due to immunogenicity, off‐target effects and organ‐specific ...
Fraser J. H. Henderson, Simon L. Hill
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Advanced Therapy Medicinal Products

Advanced therapy medicinal products are a rapidly expanding drug class based on genes, cells, and tissues, transforming the treatment of diseases, including haematologic cancers and genetic disorders, such as sickle cell disease and haemophilia.
Fausch Inesa, Mahalatchimy Aurélie
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Regulatory Frameworks for Advanced Therapy Medicinal Products in Thailand

2023
Advanced Therapy Medicinal Products (ATMPs) are a new class of medicinal products that fall under the Drug Act. B.E.2510. The Medicines Regulation Division, a regulatory unit under the Thai Food and Drug Administration, takes responsibility for the regulation of ATMPs.
Piyanan, Boonprasirt, Sarun, Nimvorapun, Chonticha, Sawangjang, Sitanun, Poonpolsub, Worasuda, Yoongthong, Paisarn, Dunkum   +5 more
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Advanced Therapy Medicinal Products (ATMPs)

2022
Over the last few decades a new group of medicinal products have emerged and have been named advanced therapy medicinal products (ATMPs). These are categorised separately from conventional treatments such as pharmaceuticals and medical devices due to their biological origin.
M. L. D. Rayner, J. B. Phillips
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Participation of patients in the development of advanced therapy medicinal products

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, 2011
An increasing number of advanced therapy medicinal products (ATMPs) are under development and in clinical trials. Patients are central to this progress. In research, patients have funded, catalysed, coordinated and led projects. In regulation, patient groups have contributed to the creation of the political momentum for regulation of ATMPs, contributed
F, Bignami, A J, Kent, M, Lipucci di Paola, N, Meade   +3 more
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Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU

2023
In the European Union (EU), advanced therapy medicinal products (ATMPs) undergo evaluation by the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) to obtain marketing authorization under the centralized procedure. Because of the diversity and complexity of ATMPs, a tailored approach to the regulatory process is required that ...
Shayesteh, Fürst-Ladani, Anja, Bührer, Walter, Fürst, Nathalie, Schober-Ladani   +3 more
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Advanced therapy medicinal products (ATMPs)

Abstract The EU and UK regulatory framework for ATMPs is described alongside the concepts of ATMP classification and hospital exceptions. An example of the role of a not-for-profit organization in the development of ATMPs in the UK is included.
Phil Ambery, Adrian Kilcoyne, Daniel O’Connor   +2 more
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Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany

2015
In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products.
Matthias, Renner, Brigitte, Anliker, Ralf, Sanzenbacher, Silke, Schuele   +3 more
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Pharmacotherapeutic management of advanced therapy medicinal products

2022
Advanced therapy medicinal products have emerged in recent years as new pharmacotherapeutic strategies. In this context, hospital pharmacy services have had to adapt to the new challenges posed by the inclusion of advanced therapies in their roster of services against the background of the complex pharmacotherapeutic process patients typically go ...
Luis Poveda-Andres, Jose, Jose Ruiz-Caldes, Maria, Jose Carreras-Soler, Maria, Clopes-Estela, Ana, Flores-Moreno, Sandra, Garcia-Pellicer, Javier, Giraldez-Quiroga, Miriam, Lopez-Briz, Eduardo, Lozano-Blazquez, Ana, Eduardo Megias-Vericat, Juan, Tordera-Baviera, Maria, Valero-Garcia, Silvia   +11 more
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