Works matching DE "EUROPEAN Medicines Agency"

Results: 1668

Expert opinion on the treatment of vulvovaginal atrophy with ospemifene based on new evidence.

Published in:

Climacteric, 2023, v. 26, n. 4, p. 388, doi. 10.1080/13697137.2023.2190881

By:

Palacios, S.;
Nappi, R. E.;
Cancelo, M. J.;
Sánchez, S.;
Simoncini, T.

Publication type:

Article

Recommendation for the collection and analysis of endometrial biopsies for hormone therapies.

Published in:

Climacteric, 2012, v. 15, n. 1, p. 52, doi. 10.3109/13697137.2011.587055

By:

Gerlinger, C.;
Gude, K.;
Alinčić-Kunz, S.;
Schäfers, M.

Publication type:

Article

Palovarotene approved as first treatment for fibrodysplasia ossificans progressiva (FOP).

Published in:

2024

By:

Talha, Muhammad;
Ali, Mohammad Haris

Publication type:

Letter

On the statistical model of the two-stage designs in bioequivalence assessment.

Published in:

Journal of Pharmacy & Pharmacology, 2014, v. 66, n. 1, p. 48, doi. 10.1111/jphp.12164

By:

Karalis, Vangelis;
Macheras, Panos

Publication type:

Article

Comparability Pathway for the Approval of Similar Biologics with Respect to Reference Biologics in Europe and Brazil.

Published in:

Indian Journal of Pharmaceutical Education & Research, 2020, v. 54, p. S19, doi. 10.5530/ijper.54.2s.58

By:

Nori, Lakshmi Prasanthi;
Ravi, Prasuna

Publication type:

Article

Arctium lappa and Arctium tomentosum , Sources of Arctii radix : Comparison of Anti-Lipoxygenase and Antioxidant Activity as well as the Chemical Composition of Extracts from Aerial Parts and from Roots.

Published in:

Plants (2223-7747), 2021, v. 10, n. 1, p. 78, doi. 10.3390/plants10010078

By:

Skowrońska, Weronika;
Granica, Sebastian;
Dziedzic, Magdalena;
Kurkowiak, Justyna;
Ziaja, Maria;
Bazylko, Agnieszka

Publication type:

Article

DNA-Based Authentication and Metabolomics Analysis of Medicinal Plants Samples by DNA Barcoding and Ultra-High-Performance Liquid Chromatography/Triple Quadrupole Mass Spectrometry (UHPLC-MS).

Published in:

Plants (2223-7747), 2020, v. 9, n. 11, p. 1601, doi. 10.3390/plants9111601

By:

Sánchez, Marta;
González-Burgos, Elena;
Divakar, Pradeep Kumar;
Gómez-Serranillos, M. Pilar

Publication type:

Article

Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review.

Published in:

Pharmacy, 2023, v. 11, n. 1, p. 15, doi. 10.3390/pharmacy11010015

By:

Bhutkar, Renu;
Collins, Jack C.;
O'Reilly, Claire L.;
El-Den, Sarira

Publication type:

Article

International guidance on the selection of patient-reported outcome measures in clinical trials: a review.

Published in:

Quality of Life Research, 2021, v. 30, n. 1, p. 21, doi. 10.1007/s11136-020-02625-z

By:

Crossnohere, Norah L.;
Brundage, Michael;
Calvert, Melanie J.;
King, Madeleine;
Reeve, Bryce B.;
Thorner, Elissa;
Wu, Albert W.;
Snyder, Claire

Publication type:

Article

International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies.

Published in:

2016

By:

Kyte, Derek;
Reeve, Bryce;
Efficace, Fabio;
Haywood, Kirstie;
Mercieca-Bebber, Rebecca;
King, Madeleine;
Norquist, Josephine;
Lenderking, William;
Snyder, Claire;
Ring, Lena;
Velikova, Galina;
Calvert, Melanie;
Reeve, Bryce B;
King, Madeleine T;
Norquist, Josephine M;
Lenderking, William R

Publication type:

journal article

Limited availability of methods for the detection of xenotransplantation‐relevant viruses in veterinary laboratories.

Published in:

Xenotransplantation, 2024, v. 31, n. 3, p. 1, doi. 10.1111/xen.12851

By:

Denner, Joachim

Publication type:

Article

Solid organ xenotransplantation at the interface between research and clinical development: Regulatory aspects.

Published in:

Xenotransplantation, 2020, v. 27, n. 3, p. 1, doi. 10.1111/xen.12608

By:

Schuurman, Henk‐Jan;
Hoogendoorn, Karin

Publication type:

Article

The rationale and practical issues for the maintenance of clean herds for clinical islet xenotransplantation.

Published in:

Xenotransplantation, 2008, v. 15, n. 2, p. 91, doi. 10.1111/j.1399-3089.2008.00458.x

By:

O’Connell, Philip J.

Publication type:

Article

Procjena rizika od nastanka karcinoma povezanog s primjenom antihipertenziva.

Published in:

Cardiologia Croatica, 2019, v. 14, n. 5/6, p. 126, doi. 10.15836/ccar2019.126

By:

Levicki, Rea;
Benčić, Martina Lovrić;
Jelaković, Bojan

Publication type:

Article

Comparative physicochemical and structural characterisation studies establish high biosimilarity between BGL-ASP and reference insulin aspart.

Published in:

Scientific Reports, 2024, v. 14, n. 1, p. 1, doi. 10.1038/s41598-024-54819-x

By:

Ghade, Nikhil S.;
Thappa, Damodar K.;
Lona, Jeseena;
Krishnan, Archana R.;
Sonar, Sanjay M.

Publication type:

Article

Pharmaceutical Cocrystals a Patentable Composition - A Review.

Published in:

International Journal of Pharmaceutical Research & Allied Sciences, 2023, v. 12, n. 4, p. 1, doi. 10.51847/eGq6tbgNvd

By:

Ramadoss, Karthikeyan;
Ganapathi, Haema;
Venugopal, Vijayan;
Sundaram, Sakthiganapathi Meenatchi;
Seetharaman, Shanmuganathan;
Vadivel, Velmurugan

Publication type:

Article

Joint Statement of EFSA and EMA on the presence of residues of phenylbutazone in horse meat.

Published in:: EFSA Journal, 2013, v. 11, n. 4, p. n/a, doi. 10.2903/j.efsa.2013.3190
Publication type:: Article

Dry Powder Inhalers: A Review.

Published in:

Indo Global Journal of Pharmaceutical Sciences, 2013, v. 3, n. 2, p. 142, doi. 10.35652/igjps.2013.17

By:

Yadav, Niti;
Lohani, Alka

Publication type:

Article

Clinical aspects of reimbursement policies for orphan drugs in Central and Eastern European countries.

Published in:

Frontiers in Pharmacology, 2024, p. 1, doi. 10.3389/fphar.2024.1369178

By:

Jakubowski, Szczepan;
Kawalec, Pawel;
Holko, Przemyslaw;
Kowalska-Bobko, Iwona;
Kamusheva, Maria;
Petrova, Guenka;
Draganić, Pero;
Fuksa, Leos;
Männik, Agnes;
Ispán, Fanni;
Briedis, Vitalis;
Bianchi, Ioana;
Paveliu, Marian Sorin;
Tesar, Tomas

Publication type:

Article

The impact of level of documentation on the accessibility and affordability of new drugs in Norway.

Published in:

Frontiers in Pharmacology, 2024, p. 1, doi. 10.3389/fphar.2024.1338541

By:

Fagereng, Gro Live;
Morvik, Anne Marit;
Ulimoen, Sara Reinvik;
Ringerud, Anne Marthe;
Syversen, Iselin Dahlen;
Sagdahl, Erik

Publication type:

Article

Advancing the use of real world evidence in health technology assessment: insights from a multi-stakeholder workshop.

Published in:

Frontiers in Pharmacology, 2024, p. 1, doi. 10.3389/fphar.2023.1289365

By:

Claire, Ravinder;
Elvidge, Jamie;
Hanif, Shahid;
Goovaerts, Hannah;
Rijnbeek, Peter R.;
Jónsson, Páll;
Facey, Karen;
Dawoud, Dalia

Publication type:

Article

Antisense oligonucleotides: a novel Frontier in pharmacological strategy.

Published in:

Frontiers in Pharmacology, 2023, p. 1, doi. 10.3389/fphar.2023.1304342

By:

Collotta, D.;
Bertocchi, I.;
Chiapello, E.;
Collino, M.

Publication type:

Article

A comprehensive overview on antibody-drug conjugates: from the conceptualization to cancer therapy.

Published in:

Frontiers in Pharmacology, 2023, p. 1, doi. 10.3389/fphar.2023.1274088

By:

Riccardi, Federico;
Dal Bo, Michele;
Macor, Paolo;
Toffoli, Giuseppe

Publication type:

Article

The challenges of access to innovative medicines with limited evidence in the European Union.

Published in:

Frontiers in Pharmacology, 2023, p. 1, doi. 10.3389/fphar.2023.1215431

By:

Vallano, Antonio;
Pontes, Caridad;
Agustí, Antònia

Publication type:

Article

The therapeutic value of treatment for multiple sclerosis: analysis of health technology assessments of three European countries.

Published in:

Frontiers in Pharmacology, 2023, p. 1, doi. 10.3389/fphar.2023.1169400

By:

Gozzo, Lucia;
Romano, Giovanni Luca;
Brancati, Serena;
Longo, Laura;
Vitale, Daniela Cristina;
Drago, Filippo

Publication type:

Article

Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.

Published in:

Frontiers in Pharmacology, 2017, p. 1, doi. 10.3389/fphar.2017.00497

By:

Bonanno, Patricia Vella;
Ermisch, Michael;
Godman, Brian;
Martin, Antony P.;
Van Den Bergh, Jesper;
Bezmelnitsyna, Liudmila;
Bucsics, Anna;
Arickx, Francis;
Bybau, Alexander;
Bochenek, Tomasz;
van de Casteele, Marc;
Diogene, Eduardo;
Eriksson, Irene;
Fürst, Jurij;
Gad, Mohamed;
Greičiūtė-Kuprijanov, Ieva;
van der Graaff, Martin;
Gulbinovic, Jolanta;
Jones, Jan;
Joppi, Roberta

Publication type:

Article

Threshold for defining PSMA-positivity prior to 177Lu-PSMA therapy: a comparison of [68Ga]Ga-PSMA-11 and [18F]F-DCFPyL in metastatic prostate cancer.

Published in:

EJNMMI Research, 2023, v. 13, n. 1, p. 1, doi. 10.1186/s13550-023-01033-x

By:

Heilinger, Jan;
Weindler, Jasmin;
Roth, Katrin Sabine;
Krapf, Philipp;
Schomäcker, Klaus;
Dietlein, Markus;
Drzezga, Alexander;
Kobe, Carsten

Publication type:

Article

The introduction of nitrosamine impurities in medicinal products.

Published in:

Journal of Chinese Pharmaceutical Sciences, 2023, v. 32, n. 3, p. 223, doi. 10.5246/jcps.2023.03.020

By:

Jianzhao Niu;
Dongsheng Yang;
Yufei Feng;
Baihao Sun;
Haoyue Guan;
Lingyun Ma

Publication type:

Article

Who are the PDCO?

Published in:

European Journal of Pediatrics, 2014, v. 173, n. 2, p. 233, doi. 10.1007/s00431-013-2096-2

By:

Dempsey, E.;
Connolly, K.

Publication type:

Article

Over-the-counter drug use--estimations within the Swedish paediatric population.

Published in:

2011

By:

Nydert, Per;
Kimland, Elin;
Kull, Inger;
Lindemalm, Synnöve;
Lindemalm, Synnöve

Publication type:

journal article

Outcomes of Thyrotropin Alfa Versus Levothyroxine Withdrawal-Aided Radioiodine Therapy for Distant Metastasis of Papillary Thyroid Cancer.

Published in:

Thyroid, 2021, v. 31, n. 10, p. 1514, doi. 10.1089/thy.2021.0013

By:

Simões-Pereira, Joana;
Ferreira, Teresa C.;
Limbert, Edward;
Cavaco, Branca Maria;
Leite, Valeriano

Publication type:

Article

Osilodrostat for Cushing Disease and Its Role in Pediatrics.

Published in:

Hormone Research in Paediatrics, 2023, v. 96, n. 6, p. 573, doi. 10.1159/000522054

By:

Groselj, Urh;
Sikonja, Jaka;
Battelino, Tadej

Publication type:

Article

Safety and Effectiveness of Recombinant Human Growth Hormone in Children with Turner Syndrome: Data from the PATRO Children Study.

Published in:

Hormone Research in Paediatrics, 2021, v. 94, n. 3/4, p. 133, doi. 10.1159/000515875

By:

Backeljauw, Philippe;
Kanumakala, Shankar;
Loche, Sandro;
Schwab, Karl Otfried;
Pfäffle, Roland Werner;
Höybye, Charlotte;
Lundberg, Elena;
Battelino, Tadej;
Kriström, Berit;
Giemza, Tomasz;
Zouater, Hichem

Publication type:

Article

Mechanisms of Resistance and Therapeutic Perspectives in Immunotherapy for Advanced Head and Neck Cancers.

Published in:

Cancers, 2024, v. 16, n. 4, p. 703, doi. 10.3390/cancers16040703

By:

Meci, Andrew;
Goyal, Neerav;
Slonimsky, Guy

Publication type:

Article

Molecular Biology and Therapeutic Perspectives for K-Ras Mutant Non-Small Cell Lung Cancers.

Published in:

Cancers, 2022, v. 14, n. 17, p. 4103, doi. 10.3390/cancers14174103

By:

Cekani, Elona;
Epistolio, Samantha;
Dazio, Giulia;
Cefalì, Marco;
Wannesson, Luciano;
Frattini, Milo;
Froesch, Patrizia

Publication type:

Article

Monoclonal Antibodies in the Treatment of Diffuse Large B-Cell Lymphoma: Moving beyond Rituximab.

Published in:

Cancers, 2022, v. 14, n. 8, p. 1917, doi. 10.3390/cancers14081917

By:

Papageorgiou, Sotirios G.;
Thomopoulos, Thomas P.;
Liaskas, Athanasios;
Vassilakopoulos, Theodoros P.

Publication type:

Article

FDA-Approved Drugs for Hematological Malignancies—The Last Decade Review.

Published in:

Cancers, 2022, v. 14, n. 1, p. 87, doi. 10.3390/cancers14010087

By:

Sochacka-Ćwikła, Aleksandra;
Mączyński, Marcin;
Regiec, Andrzej

Publication type:

Article

Breast Cancer Drug Approvals Issued by EMA: A Review of Clinical Trials.

Published in:

Cancers, 2021, v. 13, n. 20, p. 5198, doi. 10.3390/cancers13205198

By:

Duranti, Simona;
Fabi, Alessandra;
Filetti, Marco;
Falcone, Rosa;
Lombardi, Pasquale;
Daniele, Gennaro;
Franceschini, Gianluca;
Carbognin, Luisa;
Palazzo, Antonella;
Garganese, Giorgia;
Paris, Ida;
Scambia, Giovanni;
Pietragalla, Antonella

Publication type:

Article

AN ECONOMIC PRICE ANALYSIS OF CONVENTIONAL REMISSION THERAPY VS BIOLOGICAL THERAPY FOR RHEUMATOID ARTHRITIS TREATMENT.

Published in:

Management & Marketing Journal, 2019, v. 17, n. 1, p. 39

By:

SUBTIRELU, Mihaela-Simona;
TURCU-STIOLICA, Adina;
VREJU, Florentin-Ananu;
NEAMTU, Johny

Publication type:

Article

Hypoglycemia: a review of definitions used in clinical trials evaluating antihyperglycemic drugs for diabetes.

Published in:

Clinical Epidemiology, 2017, v. 9, p. 291, doi. 10.2147/CLEP.S129268

By:

Balijepalli, Chakrapani;
Druyts, Eric;
Siliman, Gaye;
Joffres, Michel;
Thorlund, Kristian;
Mills, Edward J.

Publication type:

Article

Presence of emerging contaminants in baby food.

Published in:

Food Additives & Contaminants. Part A: Chemistry, Analysis, Control, Exposure & Risk Assessment, 2020, v. 37, n. 1, p. 131, doi. 10.1080/19440049.2019.1682686

By:

Nobile, Maria;
Arioli, Francesco;
Pavlovic, Radmila;
Ceriani, Federica;
Lin, Shih-Kuo;
Panseri, Sara;
Villa, Roberto;
Chiesa, Luca Maria

Publication type:

Article

Brexit: Severe Risks to Britain's National Health Service.

Published in:

American Journal of Public Health, 2017, v. 107, n. 10, p. 1594, doi. 10.2105/AJPH.2017.304010

By:

Park, John J.;
McKee, Martin;
Atun, Rifat

Publication type:

Article

The efficacy of immune checkpoint inhibitors in thoracic malignancies.

Published in:

European Respiratory Review, 2021, v. 30, n. 162, p. 1, doi. 10.1183/16000617.0387-2020

By:

Remon, Jordi;
Facchinetti, Francesco;
Besse, Benjamin

Publication type:

Article

Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis.

Published in:

BMC Research Notes, 2019, v. 12, n. 1, p. N.PAG, doi. 10.1186/s13104-019-4507-6

By:

Holmøy, Trygve;
Fevang, Børre;
Olsen, David Benee;
Spigset, Olav;
Bø, Lars

Publication type:

Article

European authorities recommend granting Lumigan 0.01% marketing approval in Europe.

Published in:: Ocular Surgery News, 2009, v. 27, n. 22, p. 49
Publication type:: Article

Praziquantel-related visual disorders among recipients in mass drug administration campaigns in schistosomiasis endemic settings: Systematic review and meta-analysis protocol.

Published in:

PLoS ONE, 2024, v. 19, n. 5, p. 1, doi. 10.1371/journal.pone.0300384

By:

Danso-Appiah, Anthony;
Owiredu, David;
Akuffo, Kwadwo Owusu

Publication type:

Article

A full-document analysis of the semantic relation between European Public Assessment Reports and EMA guidelines using a BERT language model.

Published in:

PLoS ONE, 2023, v. 18, n. 12, p. 1, doi. 10.1371/journal.pone.0294560

By:

Bergman, Erik;
Pasmooij, Anna Maria Gerdina;
Mol, Peter G. M.;
Westman, Gabriel

Publication type:

Article

Modeling the public health impact of voxelotor in the management of sickle cell disease in France.

Published in:

PLoS ONE, 2023, v. 18, n. 9, p. 1, doi. 10.1371/journal.pone.0291211

By:

Galacteros, Frédéric;
Ethgen, Olivier;
Beillat, Maud

Publication type:

Article

Denosumab-Breakthrough Biological.

Published in:

2012

By:

Sudhaa Sharma;
Shagun Mahajan;
Vishal R. Tandon;
Annil Mahajan

Publication type:

Editorial

Efficacy and Safety Outcomes Up to ~4 Years of Treatment With Filgotinib 200 mg Among Patients With Ulcerative Colitis: Results From the SELECTIONLTE Study.

Published in:: Gastroenterology & Hepatology, 2023, v. 19, p. 10
Publication type:: Article