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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| ISSN: | 1550-7416 |
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| DOI: | 10.1208/s12248-024-00968-w |
