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Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.

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Bibliographic Details
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
Description
ISSN:1179-190X
DOI:10.1007/s40259-025-00755-9