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Items: 1 to 50 of 58

1.

EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma.

Tzogani K, Hennik PV, Walsh I, De Graeff P, Folin A, Sjöberg J, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti F.

Oncologist. 2018 Jul;23(7):870. doi: 10.1634/theoncologist.2017-0301erratum. No abstract available.

2.

EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma.

Tzogani K, Penninga E, Schougaard Christiansen ML, Hovgaard D, Sarac SB, Camarero Jimenez J, Garcia I, Lafuente M, Sancho-López A, Salmonson T, Gisselbrecht C, Pignatti F.

Oncologist. 2018 May;23(5):594-602. doi: 10.1634/theoncologist.2017-0328. Epub 2018 Jan 25.

3.

Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

Sullivan JO, Blake K, Berntgen M, Salmonson T, Welink J; Pharmacokinetics Working Party.

Clin Pharmacol Ther. 2018 Sep;104(3):539-545. doi: 10.1002/cpt.957. Epub 2018 Jan 9.

PMID:
29319156
4.

EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma.

Tzogani K, van Hennik P, Walsh I, De Graeff P, Folin A, Sjöberg J, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti F.

Oncologist. 2018 May;23(5):631-636. doi: 10.1634/theoncologist.2017-0301. Epub 2017 Nov 30. Erratum in: Oncologist. 2018 Jul;23(7):870.

5.

Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Cilia M, Ruiz S, Richardson P, Salmonson T, Serracino-Inglott A, Wirth F, Borg JJ.

AAPS PharmSciTech. 2018 Feb;19(2):489-511. doi: 10.1208/s12249-017-0892-0. Epub 2017 Oct 12.

PMID:
29027130
6.

The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy.

Tzogani K, Camarero Jiménez J, Garcia I, Sancho-López A, Martin M, Moreau A, Demolis P, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti F.

Oncologist. 2017 Nov;22(11):1339-1346. doi: 10.1634/theoncologist.2017-0184. Epub 2017 Sep 21.

7.

European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer.

Stanel SC, Sjöberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F.

ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017. Review.

8.

Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases.

Stefanska AM, Distlerová D, Musaus J, Olski TM, Dunder K, Salmonson T, Mentzer D, Müller-Berghaus J, Hemmings R, Veselý R.

Arch Dis Child. 2017 Oct;102(10):952-957. doi: 10.1136/archdischild-2016-312259. Epub 2017 May 29. Review.

PMID:
28554892
9.

The European Medicines Agency review of pitolisant for treatment of narcolepsy: summary of the scientific assessment by the Committee for Medicinal Products for Human Use.

Kollb-Sielecka M, Demolis P, Emmerich J, Markey G, Salmonson T, Haas M.

Sleep Med. 2017 May;33:125-129. doi: 10.1016/j.sleep.2017.01.002. Epub 2017 Feb 11.

PMID:
28449891
10.

Non-vitamin-K oral anticoagulants and laboratory testing: now and in the future: Views from a workshop at the European Medicines Agency (EMA).

Salmonson T, Dogné JM, Janssen H, Garcia Burgos J, Blake P.

Eur Heart J Cardiovasc Pharmacother. 2017 Jan;3(1):42-47. doi: 10.1093/ehjcvp/pvw032. Epub 2016 Dec 25.

11.

Regulatory watch: Challenges in drug development for central nervous system disorders: a European Medicines Agency perspective.

Butlen-Ducuing F, Pétavy F, Guizzaro L, Zienowicz M, Haas M, Alteri E, Salmonson T, Corruble E.

Nat Rev Drug Discov. 2016 Nov 29;15(12):813-814. doi: 10.1038/nrd.2016.237. No abstract available.

PMID:
27895328
12.

The European Medicines Agency Review of Decitabine (Dacogen) for the Treatment of Adult Patients With Acute Myeloid Leukemia: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use.

Nieto M, Demolis P, Béhanzin E, Moreau A, Hudson I, Flores B, Stemplewski H, Salmonson T, Gisselbrecht C, Bowen D, Pignatti F.

Oncologist. 2016 Jun;21(6):692-700. doi: 10.1634/theoncologist.2015-0298. Epub 2016 Apr 18.

13.

Regulatory Reply to the ATMOSPHERE Data Monitoring Committee.

Salmonson T, Janssen H, Sudhop T, Stahl E.

N Engl J Med. 2016 Apr 21;374(16):1585-6. doi: 10.1056/NEJMc1603514. Epub 2016 Apr 4. No abstract available.

14.

A viewpoint on European Medicines Agency experience with investigational medicinal products for Ebola.

Cavaleri M, Thomson A, Salmonson T, Hemmings RJ.

Clin Trials. 2016 Feb;13(1):101-4. doi: 10.1177/1740774515619860. Epub 2016 Jan 14. No abstract available.

PMID:
26768561
15.

Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators.

Postmus D, Mavris M, Hillege HL, Salmonson T, Ryll B, Plate A, Moulon I, Eichler HG, Bere N, Pignatti F.

Clin Pharmacol Ther. 2016 May;99(5):548-54. doi: 10.1002/cpt.332. Epub 2016 Feb 17.

PMID:
26715217
16.

The European Medicines Agency Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult Patients With Relapsed or Refractory CD30+ Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use.

Gravanis I, Tzogani K, van Hennik P, de Graeff P, Schmitt P, Mueller-Berghaus J, Salmonson T, Gisselbrecht C, Laane E, Bergmann L, Pignatti F.

Oncologist. 2016 Jan;21(1):102-9. doi: 10.1634/theoncologist.2015-0276. Epub 2015 Nov 30.

17.

Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future Directions.

Pignatti F, Ashby D, Brass EP, Eichler HG, Frey P, Hillege HL, Hori A, Levitan B, Liberti L, Löfstedt RE, McAuslane N, Micaleff A, Noel RA, Postmus D, Renn O, Sabourin BJ, Salmonson T, Walker S.

Clin Pharmacol Ther. 2015 Nov;98(5):522-33. doi: 10.1002/cpt.203. Epub 2015 Sep 11. Review.

18.

A coordinated cross-disciplinary research initiative to address an increased incidence of narcolepsy following the 2009-2010 Pandemrix vaccination programme in Sweden.

Feltelius N, Persson I, Ahlqvist-Rastad J, Andersson M, Arnheim-Dahlström L, Bergman P, Granath F, Adori C, Hökfelt T, Kühlmann-Berenzon S, Liljeström P, Maeurer M, Olsson T, Örtqvist Å, Partinen M, Salmonson T, Zethelius B.

J Intern Med. 2015 Oct;278(4):335-53. doi: 10.1111/joim.12391. Epub 2015 Jun 30. Review.

19.

The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use.

Hanaizi Z, Flores B, Hemmings R, Camarero J, Sancho-Lopez A, Salmonson T, Gisselbrecht C, Laane E, Pignatti F.

Oncologist. 2015 Mar;20(3):329-34. doi: 10.1634/theoncologist.2014-0073. Epub 2015 Feb 11. Review.

20.

From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.

Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G.

Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4.

PMID:
25669457
21.

The European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for human use.

Tzogani K, Skibeli V, Westgaard I, Dalhus M, Thoresen H, Slot KB, Damkier P, Hofland K, Borregaard J, Ersbøll J, Salmonson T, Pieters R, Sylvester R, Mickisch G, Bergh J, Pignatti F.

Oncologist. 2015 Feb;20(2):196-201. doi: 10.1634/theoncologist.2014-0177. Epub 2015 Jan 23. Review.

22.

European regulatory experience with drugs for central nervous system disorders.

Butlen-Ducuing F, Zienowicz M, Pétavy F, Haas M, Salmonson T, Eichler HG, Rasi G.

Nat Rev Drug Discov. 2015 Feb;14(2):89-90. doi: 10.1038/nrd4511. Epub 2014 Dec 19. No abstract available.

PMID:
25524018
23.

European Medicines Agency review of ataluren for the treatment of ambulant patients aged 5 years and older with Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene.

Haas M, Vlcek V, Balabanov P, Salmonson T, Bakchine S, Markey G, Weise M, Schlosser-Weber G, Brohmann H, Yerro CP, Mendizabal MR, Stoyanova-Beninska V, Hillege HL.

Neuromuscul Disord. 2015 Jan;25(1):5-13. doi: 10.1016/j.nmd.2014.11.011. Epub 2014 Nov 24. No abstract available.

PMID:
25497400
24.
25.

Accelerated access to innovative medicines for patients in need.

Baird LG, Banken R, Eichler HG, Kristensen FB, Lee DK, Lim JC, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G.

Clin Pharmacol Ther. 2014 Nov;96(5):559-71. doi: 10.1038/clpt.2014.145. Epub 2014 Jul 9.

PMID:
25006877
26.

The European Medicines Agency Review of Pertuzumab for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer: summary of the scientific assessment of the committee for medicinal products for human use.

Boix-Perales H, Borregaard J, Jensen KB, Ersbøll J, Galluzzo S, Giuliani R, Ciceroni C, Melchiorri D, Salmonson T, Bergh J, Schellens JH, Pignatti F.

Oncologist. 2014 Jul;19(7):766-73. doi: 10.1634/theoncologist.2013-0348. Epub 2014 Jun 13. Review.

27.

The European medicines agency review of bosutinib for the treatment of adult patients with chronic myelogenous leukemia: summary of the scientific assessment of the committee for medicinal products for human use.

Hanaizi Z, Unkrig C, Enzmann H, Camarero J, Sancho-Lopez A, Salmonson T, Gisselbrecht C, Laane E, Pignatti F.

Oncologist. 2014 Apr;19(4):421-5. doi: 10.1634/theoncologist.2013-0294. Epub 2014 Mar 25.

28.

The risks of risk aversion in drug regulation.

Eichler HG, Bloechl-Daum B, Brasseur D, Breckenridge A, Leufkens H, Raine J, Salmonson T, Schneider CK, Rasi G.

Nat Rev Drug Discov. 2013 Dec;12(12):907-16. doi: 10.1038/nrd4129. Epub 2013 Nov 15. Review.

PMID:
24232377
29.

The European medicines agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the committee for medicinal products for human use.

Gravanis I, Lopez AS, Hemmings RJ, Jiménez JC, Garcia-Carbonero R, Gallego IG, Giménez EV, O'Connor D, Giuliani R, Salmonson T, Pignatti F.

Oncologist. 2013;18(9):1032-42. doi: 10.1634/theoncologist.2013-0092. Epub 2013 Aug 21.

30.

Regulatory evaluation of Glybera in Europe - two committees, one mission.

Melchiorri D, Pani L, Gasparini P, Cossu G, Ancans J, Borg JJ, Drai C, Fiedor P, Flory E, Hudson I, Leufkens HG, Müller-Berghaus J, Narayanan G, Neugebauer B, Pokrotnieks J, Robert JL, Salmonson T, Schneider CK.

Nat Rev Drug Discov. 2013 Sep;12(9):719. doi: 10.1038/nrd3835-c1. Epub 2013 Aug 19. No abstract available.

PMID:
23954897
31.

The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop.

Manolis E, Rohou S, Hemmings R, Salmonson T, Karlsson M, Milligan PA.

CPT Pharmacometrics Syst Pharmacol. 2013 Feb 27;2:e31. doi: 10.1038/psp.2013.7.

32.

Linaclotide for treatment of irritable bowel syndrome--the view of European regulators.

Berntgen M, Enzmann H, Schabel E, Prieto Yerro C, Gómez-Outes A, Salmonson T, Musaus J.

Dig Liver Dis. 2013 Sep;45(9):724-6. doi: 10.1016/j.dld.2013.03.017. Epub 2013 May 21. No abstract available.

PMID:
23701993
33.

The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the committee for medicinal products for human use.

Péan E, Flores B, Hudson I, Sjöberg J, Dunder K, Salmonson T, Gisselbrecht C, Laane E, Pignatti F.

Oncologist. 2013;18(5):625-33. doi: 10.1634/theoncologist.2013-0020. Epub 2013 Apr 24.

34.

The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

Tzogani K, Straube M, Hoppe U, Kiely P, O'Dea G, Enzmann H, Salmon P, Salmonson T, Pignatti F.

J Dermatolog Treat. 2014 Oct;25(5):371-4. doi: 10.3109/09546634.2013.789474. Epub 2013 May 21.

PMID:
23550714
35.

Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude.

Ehmann F, Papaluca Amati M, Salmonson T, Posch M, Vamvakas S, Hemmings R, Eichler HG, Schneider CK.

Clin Pharmacol Ther. 2013 May;93(5):425-32. doi: 10.1038/clpt.2013.14. Epub 2013 Jan 24.

PMID:
23549149
36.

The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

da Rocha Dias S, Salmonson T, van Zwieten-Boot B, Jonsson B, Marchetti S, Schellens JH, Giuliani R, Pignatti F.

Eur J Cancer. 2013 May;49(7):1654-61. doi: 10.1016/j.ejca.2013.01.015. Epub 2013 Mar 5.

PMID:
23481513
37.

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use.

Pean E, Klaar S, Berglund EG, Salmonson T, Borregaard J, Hofland KF, Ersbøll J, Abadie E, Giuliani R, Pignatti F.

Clin Cancer Res. 2012 Sep 1;18(17):4491-7. doi: 10.1158/1078-0432.CCR-11-3075. Epub 2012 Jul 24.

38.

Role of modelling and simulation: a European regulatory perspective.

Jönsson S, Henningsson A, Edholm M, Salmonson T.

Clin Pharmacokinet. 2012 Feb 1;51(2):69-76. doi: 10.2165/11596650-000000000-00000. Review.

PMID:
22257148
39.

New drug approval success rate in Europe in 2009.

Eichler HG, Aronsson B, Abadie E, Salmonson T.

Nat Rev Drug Discov. 2010 May;9(5):355-6. doi: 10.1038/nrd3169. No abstract available.

PMID:
20431561
41.

Safe drugs and the cost of good intentions.

Eichler HG, Abadie E, Raine JM, Salmonson T.

N Engl J Med. 2009 Apr 2;360(14):1378-80. doi: 10.1056/NEJMp0900092. No abstract available.

42.

[Generic preparations are equivalent].

Salmonson T, Edholm M.

Lakartidningen. 2008 Nov 5-11;105(45):3178. Swedish. No abstract available.

PMID:
19062608
43.

Regulatory aspects of pharmacokinetic profiling in special populations: a European perspective.

Edholm M, Gil Berglund E, Salmonson T.

Clin Pharmacokinet. 2008;47(11):693-701. Review.

PMID:
18840025
44.

A regulatory Apologia--a review of placebo-controlled studies in regulatory submissions of new-generation antidepressants.

Melander H, Salmonson T, Abadie E, van Zwieten-Boot B.

Eur Neuropsychopharmacol. 2008 Sep;18(9):623-7. doi: 10.1016/j.euroneuro.2008.06.003. Epub 2008 Jul 14.

PMID:
18621509
45.
46.

[The Medical Product Agency's work and economics--a comment].

Ahlqvist Rastad J, Salmonson T.

Lakartidningen. 2003 Jan 30;100(5):345. Swedish. No abstract available.

PMID:
12607382
47.

The effect of amiloride on the in vivo effective permeability of amoxicillin in human jejunum: experience from a regional perfusion technique.

Lennernäs H, Knutson L, Knutson T, Hussain A, Lesko L, Salmonson T, Amidon GL.

Eur J Pharm Sci. 2002 Apr;15(3):271-7.

PMID:
11923059
48.

Dosing recommendations in liver disease.

Bergquist C, Lindegård J, Salmonson T.

Clin Pharmacol Ther. 1999 Aug;66(2):201-4. No abstract available.

PMID:
10460074
49.

Pharmacokinetics of iron(III)-hydroxide sucrose complex after a single intravenous dose in healthy volunteers.

Danielson BG, Salmonson T, Derendorf H, Geisser P.

Arzneimittelforschung. 1996 Jun;46(6):615-21.

PMID:
8767353
50.

Enantioselective assay of beta-receptor antagonists present in microdialysis and plasma samples of rats.

Johansson M, Sjöberg P, Hesselgren AM, Salmonson T.

Chirality. 1995;7(4):290-6.

PMID:
7640173

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