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Expert Opinion on Pharmacotherapy Volume 16, 2015 - Issue 6
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Review

Changes and determination of dosing recommendations for medicinal products recently authorised in the European Union

Falk EhmannEuropean Medicines Agency, Clinical Pharmacology - Science and Innovation, 30 Churchill Place, Canary Wharf, London E14 5EU, [email protected]
,
Marisa PapalucaEuropean Medicines Agency, Clinical Pharmacology - Science and Innovation, 30 Churchill Place, Canary Wharf, London E14 5EU, [email protected]
,
Francesca Di GiuseppeEuropean Medicines Agency, Clinical Pharmacology - Science and Innovation, 30 Churchill Place, Canary Wharf, London E14 5EU, [email protected]
,
Luca PaniItalian Medicines Agency (AIFA), Via del Tritone, 181, 00187 Rome, Italy
,
Andrea EskovaEuropean Medicines Agency, Clinical Pharmacology - Science and Innovation, 30 Churchill Place, Canary Wharf, London E14 5EU, [email protected]
,
Efthymios ManolisEuropean Medicines Agency, Clinical Pharmacology - Science and Innovation, 30 Churchill Place, Canary Wharf, London E14 5EU, [email protected]
&
Ralf HeroldEuropean Medicines Agency, Clinical Pharmacology - Science and Innovation, 30 Churchill Place, Canary Wharf, London E14 5EU, [email protected]
 show all
Pages 903-911 | Published online: 14 Mar 2015

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Lourens T. Bloem, Mariana Karomi, Jarno Hoekman, Menno E. van der Elst, Hubert G.M. Leufkens, Olaf H. Klungel & Aukje K. Mantel-Teeuwisse. (2021) Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks. Expert Opinion on Drug Safety 20:11, pages 1433-1442.
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Articles from other publishers (5)

Reka Varnai, Istvan Szabo, Greta Tarlos, Laszlo Jozsef Szentpeteri, Attila Sik, Sandor Balogh & Csilla Sipeky. (2019) Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view. The Pharmacogenomics Journal 20:3, pages 380-387.
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Lotte A. Minnema, Thijs J. Giezen, Helga Gardarsdottir, Toine C. G. Egberts, Hubert G. M. Leufkens & Aukje K. Mantel‐Teeuwisse. (2019) Post‐marketing dosing changes in the label of biologicals. British Journal of Clinical Pharmacology 85:4, pages 715-721.
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Yvonne Schuller, Christine Gispen-de Wied, Carla E. M. Hollak, Hubertus G. M. Leufkens & Violeta Stoyanova-Beninska. (2019) Dose-Finding Studies Among Orphan Drugs Approved in the EU: A Retrospective Analysis. The Journal of Clinical Pharmacology 59:2, pages 229-244.
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Daniel Röshammar, Joakim Nyberg, Tomas Andersson, Donald Stanski, Robert F. Storey & Bengt Hamrén. (2016) Exposure‐Response Analyses Supporting Ticagrelor Dosing Recommendation in Patients With Prior Myocardial Infarction. The Journal of Clinical Pharmacology 57:5, pages 573-583.
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Manjunath P Pai. (2015) Treatment of bacterial infections in obese adult patients: how to appropriately manage antimicrobial dosage. Current Opinion in Pharmacology 24, pages 12-17.
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