Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.
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| Title: | Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies. |
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| Authors: | Bittner B; F. Hoffmann-La Roche Ltd., Global Pharma Strategy-Product Optimization, Grenzacherstr. 124, 4070, Basel, Switzerland. beate.bittner@roche.com., Munoz J; F. Hoffmann-La Roche Ltd., Global Pharma Strategy-Product Optimization, Grenzacherstr. 124, 4070, Basel, Switzerland., Frank S; F. Hoffmann-La Roche Ltd., Product Development-Regulatory Program Management, Basel, Switzerland., Dolton M; F. Genentech, Research and Early Development-Clinical Pharmacology, South San Francisco, CA, USA., Ravanello R; F. Hoffmann-La Roche Ltd, Pharma Technical-Device Development, South San Francisco, CA, USA., Dembowski M; F. Hoffmann-La Roche Ltd., Pharma Technical-Biologics, Basel, Switzerland., Clement A; F. Hoffmann-La Roche Ltd., Product Development-Regulatory Program Management, Basel, Switzerland., Richter WF; Lörrach, Germany. |
| Source: | BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy [BioDrugs] 2026 Jan; Vol. 40 (1), pp. 5-21. Date of Electronic Publication: 2025 Nov 17. |
| Publication Type: | Journal Article; Review |
| Journal Info: | Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9705305 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-190X (Electronic) Linking ISSN: 11738804 NLM ISO Abbreviation: BioDrugs Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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