A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection.
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| Title: | A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection. |
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| Authors: | Nøhr MK; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark., Waheed SR; Regulatory Affairs, Device, Novo Nordisk A/S, Søborg, Denmark., Kildemoes RJ; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark., Hatorp V; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark., Bækdal TA; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark., Adrian CL; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark., Korsholm LP; Biostatistics Research and Development, Novo Nordisk A/S, Søborg, Denmark., Arp-Hansen EL; Global Regulatory Affairs, Novo Nordisk A/S, Søborg, Denmark., Holst H; Medical & Science Rare Endocrine Disorders, LCM & Cell Therapies, Novo Nordisk A/S, Søborg, Denmark., Roberts SW; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark. osrb@novonordisk.com. |
| Source: | The AAPS journal [AAPS J] 2024 Sep 04; Vol. 26 (5), pp. 100. Date of Electronic Publication: 2024 Sep 04. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 39231891 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Nøhr+MK%22">Nøhr MK</searchLink>; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Waheed+SR%22">Waheed SR</searchLink>; Regulatory Affairs, Device, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Kildemoes+RJ%22">Kildemoes RJ</searchLink>; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Hatorp+V%22">Hatorp V</searchLink>; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Bækdal+TA%22">Bækdal TA</searchLink>; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Adrian+CL%22">Adrian CL</searchLink>; Medical & Science Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Korsholm+LP%22">Korsholm LP</searchLink>; Biostatistics Research and Development, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Arp-Hansen+EL%22">Arp-Hansen EL</searchLink>; Global Regulatory Affairs, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Holst+H%22">Holst H</searchLink>; Medical & Science Rare Endocrine Disorders, LCM & Cell Therapies, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Roberts+SW%22">Roberts SW</searchLink>; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark. osrb@novonordisk.com. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2024 Sep 04; Vol. 26 (5), pp. 100. <i>Date of Electronic Publication: </i>2024 Sep 04. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22American+Association+of+Pharmaceutical+Scientists%22">American Association of Pharmaceutical Scientists </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101223209 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1550-7416 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2215507416%22">15507416 </searchLink><i>NLM ISO Abbreviation: </i>AAPS J <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=39231891 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1208/s12248-024-00968-w Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 100 Titles: – TitleFull: A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Nøhr MK – PersonEntity: Name: NameFull: Waheed SR – PersonEntity: Name: NameFull: Kildemoes RJ – PersonEntity: Name: NameFull: Hatorp V – PersonEntity: Name: NameFull: Bækdal TA – PersonEntity: Name: NameFull: Adrian CL – PersonEntity: Name: NameFull: Korsholm LP – PersonEntity: Name: NameFull: Arp-Hansen EL – PersonEntity: Name: NameFull: Holst H – PersonEntity: Name: NameFull: Roberts SW IsPartOfRelationships: – BibEntity: Dates: – D: 04 M: 09 Text: 2024 Sep 04 Type: published Y: 2024 Identifiers: – Type: issn-electronic Value: 1550-7416 Numbering: – Type: volume Value: 26 – Type: issue Value: 5 Titles: – TitleFull: The AAPS journal Type: main |
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