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1

European regulatory experience with advanced therapy medicinal products

Barkholt, Lisbeth, Voltz-Girolt, Caroline, Raine, June, Salmonson, Tomas, Schüssler-Lenz, Martina

Journal:

Nature Reviews Drug Discovery

Year:

2019

Language:

english

File:

PDF, 150 KB

english, 2019

2

The risks of risk aversion in drug regulation

Eichler, Hans-Georg, Bloechl-Daum, Brigitte, Brasseur, Daniel, Breckenridge, Alasdair, Leufkens, Hubert, Raine, June, Salmonson, Tomas, Schneider, Christian K., Rasi, Guido

Journal:

Nature Reviews Drug Discovery

Year:

2013

Language:

english

File:

PDF, 317 KB

english, 2013

3

Exercise training-induced modification of the gut microbiota persists after microbiota colonization and attenuates the response to chemically-induced colitis in gnotobiotic mice

Allen, JM, Mailing, LJ, Cohrs, J, Salmonson, C, Fryer, J, Nehra, V, Hale, VL, Kashyap, P, White, BA, Woods, JA

Journal:

Year:

2017

Language:

english

File:

PDF, 1.44 MB

english, 2017

4

Gut microbes promote colonic serotonin production through an effect of short-chain fatty acids on enterochromaffin cells

Reigstad, C. S., Salmonson, C. E., Rainey, J. F., Szurszewski, J. H., Linden, D. R., Sonnenburg, J. L., Farrugia, G., Kashyap, P. C.

Journal:

The FASEB Journal

Year:

2015

Language:

english

File:

PDF, 860 KB

english, 2015

5

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

Butlen-Ducuing, Florence, Pétavy, Frank, Guizzaro, Lorenzo, Zienowicz, Malgorzata, Haas, Manuel, Alteri, Enrica, Salmonson, Tomas, Corruble, Emmanuelle

Journal:

Nature Reviews Drug Discovery

Year:

2016

Language:

english

File:

PDF, 136 KB

english, 2016

6

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, Marta, Demolis, Pierre, Emmerich, Joseph, Markey, Greg, Salmonson, Tomas, Haas, Manuel

Journal:

Year:

2017

Language:

english

File:

PDF, 1.13 MB

english, 2017

7

Brazed graphite/refractory metal composites for first-wall protection elements

I. Šmid, C.D. Croessmann, J.C. Salmonson, J.B. Whitley, E. Kny, N. Reheis, G. Kneringer, H. Nickel

Journal:

Journal of Nuclear Materials

Year:

1991

Language:

english

File:

PDF, 382 KB

english, 1991

8

Tuning the Implosion Symmetry of ICF Targets via Controlled Crossed-Beam Energy Transfer

Michel, P., Divol, L., Williams, E., Weber, S., Thomas, C., Callahan, D., Haan, S., Salmonson, J., Dixit, S., Hinkel, D.

Journal:

Physical Review Letters

Year:

2009

Language:

english

File:

PDF, 575 KB

english, 2009

9

A survey of pulse shape options for a revised plastic ablator ignition design

Clark, D. S., Milovich, J. L., Hinkel, D. E., Salmonson, J. D., Peterson, J. L., Berzak Hopkins, L. F., Eder, D. C., Haan, S. W., Jones, O. S., Marinak, M. M., Robey, H. F., Smalyuk, V. A., Weber, C.

Journal:

Physics of Plasmas

Year:

2014

Language:

english

File:

PDF, 9.79 MB

english, 2014

10

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.

Journal:

Year:

2015

Language:

english

File:

PDF, 791 KB

english, 2015

11

Global General Relativistic Magnetohydrodynamic Simulation of a Tilted Black Hole Accretion Disk

Fragile, P. Chris, Blaes, Omer M., Anninos, Peter, Salmonson, Jay D.

Journal:

The Astrophysical Journal

Year:

2007

Language:

english

File:

PDF, 1.17 MB

english, 2007

12

The application of a “6S Lean” initiative to improve workflow for emergency eye examination rooms

Nazarali, Samir, Rayat, Jaspreet, Salmonson, Hilary, Moss, Theodora, Mathura, Pamela, Damji, Karim F.

Journal:

Canadian Journal of Ophthalmology / Journal Canadien d'Ophtalmologie

Year:

2017

Language:

english

File:

PDF, 1.47 MB

english, 2017

13

APPLICATION OF THE CUBED-SPHERE GRID TO TILTED BLACK HOLE ACCRETION DISKS

Fragile, P. Chris, Lindner, Christopher C., Anninos, Peter, Salmonson, Jay D.

Journal:

The Astrophysical Journal

Year:

2009

File:

PDF, 1.18 MB

2009

14

Beryllium implosions at smaller case-to-capsule ratio on NIF

Zylstra, A.B., Ralph, J.E., MacLaren, S., Yi, S.A., Kyrala, G., Bachmann, B., Salmonson, J., Khan, S., MacPhee, A., Park, J., Lemos, N., Strozzi, D., Bae, J., Xu, H., Huang, H., Rice, N., Kline, J., C

Journal:

High Energy Density Physics

Year:

2020

File:

PDF, 1.29 MB

2020

15

Toxicity and serum levels of methotrexate in children with juvenile rheumatoid arthritis

Carol A. Wallace, W. Archie Bleyer, David D. Sherry, Kathy L. Salmonson, Ralph J. Wedgwood

Journal:

Arthritis & Rheumatism

Year:

1989

Language:

english

File:

PDF, 509 KB

english, 1989

16

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

Dr. Monika Johansson, Per Sjöberg, Ann-Mari Hesselgren, Thomas Salmonson

Journal:

Year:

1995

Language:

english

File:

PDF, 553 KB

english, 1995

17

Focal periportal liver steatosis

E. C. Salmonson, C. Lundstedt, T. Holmin, I. Hägerstrand

Journal:

Abdominal Imaging

Year:

1993

Language:

english

File:

PDF, 1.02 MB

english, 1993

18

Beziehungen zwischen Bewegungsfrequenz und Größe des Ausbreitungsgebietes der Erregungen

A. Bethe, A. Salmonson

Journal:

Pflügers Archiv European Journal of Physiology

Year:

1931

Language:

german

File:

PDF, 1.09 MB

german, 1931

19

High-mode Rayleigh-Taylor growth in NIF ignition capsules

B.A. Hammel, S.W. Haan, D.S. Clark, M.J. Edwards, S.H. Langer, M.M. Marinak, M.V. Patel, J.D. Salmonson, H.A. Scott

Journal:

High Energy Density Physics

Year:

2010

Language:

english

File:

PDF, 968 KB

english, 2010

20

The polarization of afterglow emission reveals γ-ray bursts jet structure

Elena M. Rossi, Davide Lazzati, Jay D. Salmonson, Gabriele Ghisellini

Journal:

Monthly Notices of the Royal Astronomical Society

Year:

2004

Language:

english

File:

PDF, 484 KB

english, 2004

21

New drug approval success rate in Europe in 2009

Eichler, Hans-Georg, Aronsson, Bo, Abadie, Eric, Salmonson, Tomas

Journal:

Nature Reviews Drug Discovery

Year:

2010

Language:

english

File:

PDF, 224 KB

english, 2010

22

Update on design simulations for NIF ignition targets, and the rollup of all specifications into an error budget

S. W. Haan, M. C. Herrmann, J. D. Salmonson, P. A. Amendt, D. A. Callahan, T. R. Dittrich, M. J. Edwards, O. S. Jones, M. M. Marinak, D. H. Munro, S. M. Pollaine, B. K. Spears, L. J. Suter

Journal:

The European Physical Journal D / Atomic, Molecular, Optical and Plasma Physics

Year:

2007

Language:

english

File:

PDF, 700 KB

english, 2007

23

Performance metrics for inertial confinement fusion implosions: Aspects of the technical framework for measuring progress in the National Ignition Campaign

Spears, Brian K., Glenzer, S., Edwards, M. J., Brandon, S., Clark, D., Town, R., Cerjan, C., Dylla-Spears, R., Mapoles, E., Munro, D., Salmonson, J., Sepke, S., Weber, S., Hatchett, S., Haan, S., Spri

Journal:

Physics of Plasmas

Year:

2012

Language:

english

File:

PDF, 1.89 MB

english, 2012

24

Design of an interactive debugger for FORTRAN: MANTIS

Gordon Ashby, Loren Salmonson, Robert Heilman

Journal:

Software: Practice and Experience

Year:

1973

Language:

english

File:

PDF, 565 KB

english, 1973

25

Pharmacokinetics and pharmacodynamics of nitroglycerin and its dinitrate metabolites in conscious dogs: Intravenous infusion studies

Frank W. Lee, Tomas Salmonson, Leslie Z. Benet

Journal:

Journal of Pharmacokinetics and Pharmacodynamics

Year:

1993

Language:

english

File:

PDF, 939 KB

english, 1993

26

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

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

Journal:

European Journal of Pharmaceutical Sciences

Year:

2002

Language:

english

File:

PDF, 164 KB

english, 2002

27

Nitrogen dioxide pneumonitis in ice hockey players

C. KARLSON-STIBER, J. HÖJER, Å . SJÖHOLM, G. BLUHM, H. SALMONSON

Journal:

Journal of Internal Medicine

Year:

1996

Language:

english

File:

PDF, 290 KB

english, 1996

28

Pharmacokinetics of intravenous recombinant human erythropoietin in patients with chronic renal failure

T. SALMONSON, B. G. DANIELSON, A. GRAHNÉN, B. WIKSTRÖM

Journal:

Journal of Internal Medicine

Year:

1990

Language:

english

File:

PDF, 350 KB

english, 1990

29

Painless juvenile rheumatoid arthritis

David D. Sherry, John Bohnsack, Kathy Salmonson, Carol A. Wallace, Elizabeth Mellins

Journal:

The Journal of Pediatrics

Year:

1990

Language:

english

File:

PDF, 277 KB

english, 1990

30

Human effective permeability data for atenolol, metoprolol, propranolol, desipramine and carbamazepine to be used in the proposed biopharmaceutical classification for IR-products

H. Lennemäs, L. Knutson, T. Knutson, L. Lesko, T. Salmonson, G.L. Amidon

Journal:

European Journal of Pharmaceutical Sciences

Year:

1996

Language:

english

File:

PDF, 183 KB

english, 1996

31

A ten-fold lower human jejunal Peff-value for α-methyldopa compared to L-dopa ar a similar luminal concentration of these two drugs

H. Lennernäs, L. Knutson, L. Lesko, T. Salmonson, G.L. Amidon

Journal:

European Journal of Pharmaceutical Sciences

Year:

1996

Language:

english

File:

PDF, 175 KB

english, 1996

32

Human effective permeability data forrurosemide, hydrochlorthiazide, ketoprofen and naproxen to be used in the proposed biopharmaceutical drug classification system for IR-products

H. Lennemäs, L. Knutson, T. Knutson, L. Lesko, T. Salmonson, G.L. Amidon

Journal:

European Journal of Pharmaceutical Sciences

Year:

1996

Language:

english

File:

PDF, 177 KB

english, 1996

33

The pharmacokinetics of recombinant human erythropoietin after intravenous and subcutaneous administration to healthy subjects.

T Salmonson, BG Danielson, B Wikstrom

Journal:

British Journal of Clinical Pharmacology

Year:

1990

Language:

english

File:

PDF, 503 KB

english, 1990

34

AIP Conference Proceedings [AIP THE 17TH INTERNATIONAL CONFERENCE ON ATOMIC PROCESSES IN PLASMAS (ICAPIP) - Belfast, Northern Ireland, UK (19–22 July 2011)] - X-ray Thomson scattering measurements from shock-compressed deuterium

Davis, P., Doeppner, T., Rygg, J. R., Fortmann, C., Unites, W., Salmonson, J., Collins, G. W., Landen, O. L., Falcone, R. W., Glenzer, S. H.

Year:

2012

Language:

english

File:

PDF, 1.37 MB

english, 2012

35

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

Hans Melander, Tomas Salmonson, Eric Abadie, Barbara van Zwieten-Boot

Journal:

European Neuropsychopharmacology

Year:

2008

Language:

english

File:

PDF, 329 KB

english, 2008

36

Regulatory Aspects of Pharmacokinetic Profiling in Special Populations

Monica Edholm, Eva Gil Berglund, Tomas Salmonson

Journal:

Clinical Pharmacokinetics

Year:

2008

Language:

english

File:

PDF, 119 KB

english, 2008

37

Role of Modelling and Simulation

Dr Siv Jönsson, Anja Henningsson, Monica Edholm, Tomas Salmonson

Journal:

Clinical Pharmacokinetics

Year:

2012

Language:

english

File:

PDF, 138 KB

english, 2012

38

A guide for reporting the results of population pharmacokinetic analyses: A Swedish perspective

Janet R. Wade, Monica Edholm, Tomas Salmonson

Journal:

The AAPS Journal

Year:

2005

Language:

english

File:

PDF, 78 KB

english, 2005

39

Effects of gamma radiation on biomass production of ground vegetation under broadleaved forests of Northern Wisconsin

Zavitkovski, J., Salmonson, B.J.

Journal:

Radiation Botany

Year:

1975

Language:

english

File:

PDF, 792 KB

english, 1975

40

Point design targets, specifications, and requirements for the 2010 ignition campaign on the National Ignition Facility

Haan, S. W., Lindl, J. D., Callahan, D. A., Clark, D. S., Salmonson, J. D., Hammel, B. A., Atherton, L. J., Cook, R. C., Edwards, M. J., Glenzer, S., Hamza, A. V., Hatchett, S. P., Herrmann, M. C., Hi

Journal:

Physics of Plasmas

Year:

2011

Language:

english

File:

PDF, 3.99 MB

english, 2011

41

Linaclotide for treatment of irritable bowel syndrome—The view of European regulators

Berntgen, Michael, Enzmann, Harald, Schabel, Elmer, Prieto Yerro, Concepcion, Gómez-Outes, Antonio, Salmonson, Tomas, Musaus, Joachim

Journal:

Digestive and Liver Disease

Year:

2013

Language:

english

File:

PDF, 253 KB

english, 2013

42

Sa2054 Germ Free Mice Have Normal Epithelial Responses to Serotonin and Acetylcholine in the Proximal Colon

Rainey, John F., Linden, David R., Grover, Madhusudan, Salmonson, Charles E., Bernard, Cheryl E., Szurszewski, Joseph H., Farrugia, Gianrico, Kashyap, Purna C.

Journal:

Gastroenterology

Year:

2014

Language:

english

File:

PDF, 142 KB

english, 2014

43

25 Colonization of Germ-Free Mice by Human Gut Microbiota Alters Colonic Morphology and Increases Tph1 Expression Likely Contributing to Altered Colonic Contractility Following Colonization

Reigstad, Christopher S., Salmonson, Charles E., Linden, David R., Szurszewski, Joseph H., Sonnenburg, Justin L., Farrugia, Gianrico, Kashyap, Purna C.

Journal:

Gastroenterology

Year:

2014

Language:

english

File:

PDF, 129 KB

english, 2014

44

Anna and the miserable man

Salmonson, Jessica Amanda

Journal:

Women's Studies International Forum

Year:

1984

Language:

english

File:

PDF, 125 KB

english, 1984

45

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, Silvy, Salmonson, Tomas, van Zwieten-Boot, Barbara, Jonsson, Bertil, Marchetti, Serena, Schellens, Jan H.M., Giuliani, Rosa, Pignatti, Francesco

Journal:

European Journal of Cancer

Year:

2013

Language:

english

File:

PDF, 3.55 MB

english, 2013

46

In Reply: Re: The Syndrome of Dysuria and Hematuria in Pediatric Urinary Reconstruction with Stomach

Nguyen, D.H., Bain, M.A., Salmonson, K.L., Ganesan, G.S., Burns, M.W., Mitchell, M.E.

Journal:

The Journal of Urology

Year:

1996

Language:

english

File:

PDF, 151 KB

english, 1996

47

Daytime incontinence

Kurtz, Melinda, Murrey, Madlyn, Salmonson, Kathy, Cornell, Cathy

Journal:

Journal of Pediatric Health Care

Year:

1993

Language:

english

File:

PDF, 73 KB

english, 1993

48

CPA's Negligence, Third Parties and the Future

R. F. Salmonson

Journal:

The Accounting Review

Year:

1959

Language:

english

File:

PDF, 213 KB

english, 1959

49

Third Party Actions against Accountants

R. F. Salmonson

Journal:

The Accounting Review

Year:

1957

Language:

english

File:

PDF, 964 KB

english, 1957

50

Regulatory Requirements for Chiral Drugs

Gross, M., Cartwright, A., Campbell, B., Bolton, R., Holmes, K., Kirkland, K., Salmonson, T., Robert, J.-L.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

1993

Language:

english

File:

PDF, 399 KB

english, 1993

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