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Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies

Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies

by Roberts, Scott W., Elvang, Tara Laura Brandt, Syed, Laila, Samuelsen, Marianne Bork, Arp-Hansen, Eva Lisby, Nielsen, Henrik Kim, Lund, Ida Katrine, Dünweber, Dorte Lunøe, Listov-Saabye, Nicolai, Bjørn-Larsen, Dorte, Hjelmsmark, Anette, Mikkelsen, Tue Anker
Published in Therapeutic innovation & regulatory science (01.03.2023)

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Journal Article

Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies

Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies

by Roberts, Scott W., Elvang, Tara Laura Brandt, Syed, Laila, Samuelsen, Marianne Bork, Arp-Hansen, Eva Lisby, Nielsen, Henrik Kim, Lund, Ida Katrine, Dünweber, Dorte Lunøe, Listov-Saabye, Nicolai, Bjørn-Larsen, Dorte, Hjelmsmark, Anette, Mikkelsen, Tue Anker
Published in Therapeutic innovation & regulatory science (01.03.2023)

Get full text

Journal Article