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Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.

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Title: Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.
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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  Data: Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.
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  Data: <searchLink fieldCode="AU" term="%22Bittner+B%22">Bittner B</searchLink>; F. Hoffmann-La Roche Ltd., Global Pharma Strategy-Product Optimization, Grenzacherstr. 124, 4070, Basel, Switzerland. beate.bittner@roche.com.<br /><searchLink fieldCode="AU" term="%22Munoz+J%22">Munoz J</searchLink>; F. Hoffmann-La Roche Ltd., Global Pharma Strategy-Product Optimization, Grenzacherstr. 124, 4070, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Frank+S%22">Frank S</searchLink>; F. Hoffmann-La Roche Ltd., Product Development-Regulatory Program Management, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Dolton+M%22">Dolton M</searchLink>; F. Genentech, Research and Early Development-Clinical Pharmacology, South San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Ravanello+R%22">Ravanello R</searchLink>; F. Hoffmann-La Roche Ltd, Pharma Technical-Device Development, South San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Dembowski+M%22">Dembowski M</searchLink>; F. Hoffmann-La Roche Ltd., Pharma Technical-Biologics, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Clement+A%22">Clement A</searchLink>; F. Hoffmann-La Roche Ltd., Product Development-Regulatory Program Management, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Richter+WF%22">Richter WF</searchLink>; Lörrach, Germany.
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  Data: <searchLink fieldCode="JN" term="%229705305%22">BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy</searchLink> [BioDrugs] 2026 Jan; Vol. 40 (1), pp. 5-21. <i>Date of Electronic Publication: </i>2025 Nov 17.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Adis%2C+Springer+International%22">Adis, Springer International </searchLink><i>Country of Publication: </i>New Zealand <i>NLM ID: </i>9705305 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1179-190X (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2211738804%22">11738804 </searchLink><i>NLM ISO Abbreviation: </i>BioDrugs <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s40259-025-00755-9
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        Text: English
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              Text: 2026 Jan
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              Y: 2026
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