Results 81 to 90 of about 7,093,593 (187)

Global regulatory frameworks and case studies of Advanced Therapy Medicinal Products (ATMPS)

Journal of Rare Diseases
Abstract Purpose Advanced Therapy Medicinal Products (ATMPs), which include tissue-engineered products, gene therapies, and somatic cell therapies, are at the pioneering of healthcare discovery and have the potential to cure ailments for which there were previously few or no therapy choices ...
Sravanthi Siliveri, Kavya Sri Ausali
openaire   +1 more source

ATMP: The road to clinical application

, 2023
479484ATMP („advanced therapy medicinal products“) sind eine neue Klasse von Arzneimitteln, die somatische Zelltherapeutika, Gentherapeutika und biotechnologisch bearbeitete Gewebeprodukte umfassen.
Fricke, Stephan, Dehmel, Susann, Braun, Armin, Neuhaus, Vanessa, Blaudszun, André-René, Augustin, Jens, Köhl, Ulrike, Vucinic, Vladan, Ueberham, Elke   +8 more
core   +1 more source

Advanced Therapy Medicinal Products (ATMPs): fundamental concepts, classification, and translational challenges

Exploration of Drug Science
Advanced 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. This review provides a foundational overview of ATMPs, addressing their scientific basis, regulatory classification ...
Alfi Sophian, Dewi Sulanjari, null Normasari, Andhika Harumanto   +3 more
openaire   +1 more source

The application of the advanced therapeutic medicinal product – hospital exemption and the therapeutic experiment

The article presents considerations based on the regulations of EU and Polish law regarding the manufacture and use of advanced therapy medicinal products – hospital exemptions.
Pecyna, Marlena
core   +1 more source

Advanced Therapy Medicinal Products

15211545In recent years advances in biology, biotechnology, and medical research have led to a new category of biologicals - the advanced therapy medicinal products (ATMPs).
Neuhaus, Vanessa, Schaudien, Dirk, Dehm, Susann   +2 more
core   +1 more source

Development and usability testing of an electronic patient-reported outcome (ePRO) solution for patients with inflammatory diseases in an Advanced Therapy Medicinal Product (ATMP) basket trial. [PDF]

J Patient Rep Outcomes, 2023
McMullan C, Retzer A, Hughes SE, Aiyegbusi OL, Bathurst C, Boyd A, Coleman J, Davies EH, Denniston AK, Dunster H, Frost C, Harding R, Hunn A, Kyte D, Malpass R, McNamara G, Mitchell S, Mittal S, Newsome PN, Price G, Rowe A, van Reil W, Walker A, Wilson R, Calvert M.   +24 more
europepmc   +1 more source

Temporomandibular Joint Osteoarthritis: Regenerative Treatment by a Stem Cell Containing Advanced Therapy Medicinal Product (ATMP)-An In Vivo Animal Trial. [PDF]

Int J Mol Sci, 2021
Köhnke R, Ahlers MO, Birkelbach MA, Ewald F, Krueger M, Fiedler I, Busse B, Heiland M, Vollkommer T, Gosau M, Smeets R, Rutkowski R.   +11 more
europepmc   +1 more source

OP73 Navigating The Advanced Therapy Medicinal Products (ATMPs) Conundrum: Insights From ATMPs Withdrawn In The European Market

International Journal of Technology Assessment in Health Care
IntroductionAdvanced therapy medicinal product (ATMP) is a classification used by the European Medicines Agency (EMA) for cell-, gene-, and tissue-engineered therapies. Since the first ATMP received market authorization in 2009, a substantial proportion of these highly innovative therapies have been withdrawn from the European market.
Leong, Katherine, Macaulay, Richard
openaire   +1 more source

Access to Advanced Therapy Medicinal Products in the EU: Where Do We Stand?

, 2011
The European Union has a public health strategy and will generally ensure in all its policies and activities a “high level of human health protection”.
Mahalatchimy, A, A. Mahalatchimy
core   +1 more source

Market Access for Advanced Therapy Medicinal Products (ATMPS) Begins at the Bench [PDF]

Value in Health, 2018
CA Jones, G Narayanan
openaire   +1 more source