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White paper: Understanding, informing and defining the regulatory science of microneedle-based dosage forms that are applied to the skin.

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Title: White paper: Understanding, informing and defining the regulatory science of microneedle-based dosage forms that are applied to the skin.
Authors: Dul M; Cardiff School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK., Alali M; World Health Organization, Geneva, Switzerland., Ameri M; Americeutics Consulting, USA; previously Zosano Pharma, USA., Burke MD; Stemline Therapeutics Inc, a Menarini Group Company, USA; previously Radius Health, Inc., USA., Creelman BP; PATH, Seattle, USA., Dick L; Previously Kindeva Drug Delivery, USA., Donnelly RF; School of Pharmacy, Queen's University Belfast, Belfast, UK., Eakins MN; Eakins & Associates, USA., Frivold C; PATH, Seattle, USA., Forster AH; Vaxxas Pty Ltd, Australia., Gilbert PA; Bill & Melinda Gates Foundation, Seattle, USA., Henke S; Bioaxxent - Drug Delivery, Germany; previously LTS Lohmann Therapie-Systeme AG, Germany., Henry S; Micron Biomedical, Inc., USA., Hunt D; United States Pharmacopeia, USA., Lewis H; Previously Zosano Pharma, USA., Mistilis JJ; PATH, Seattle, USA., Park JH; Department of Bionano Technology, Gachon University, Seongnam, Republic of Korea., Prausnitz MR; School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA., Robinson DK; Bill & Melinda Gates Foundation, Seattle, USA., Hernandez CAR; World Health Organization, Geneva, Switzerland., Shin J; Raphas Co. Ltd, Republic of Korea., Speaker TJ; AbbVie Inc, USA., Strasinger C; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), USA., Taylor KMG; University College London School of Pharmacy, UK; previously British Pharmacopoeia Commission, UK., Zehrung D; Zehrung Global Health LLC, USA., Birchall JC; Cardiff School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK., Jarrahian C; PATH, Seattle, USA., Coulman SA; Cardiff School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK. Electronic address: coulmansa@cardiff.ac.uk.
Source: Journal of controlled release : official journal of the Controlled Release Society [J Control Release] 2025 Feb 10; Vol. 378, pp. 402-415. Date of Electronic Publication: 2024 Dec 20.
Publication Type: Journal Article; Review; Consensus Statement; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Elsevier Science Publishers Country of Publication: Netherlands NLM ID: 8607908 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-4995 (Electronic) Linking ISSN: 01683659 NLM ISO Abbreviation: J Control Release Subsets: MEDLINE
Database: MEDLINE Ultimate
FullText Text:
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PubType: Academic Journal
PubTypeId: academicJournal
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  Data: White paper: Understanding, informing and defining the regulatory science of microneedle-based dosage forms that are applied to the skin.
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  Data: <searchLink fieldCode="AU" term="%22Dul+M%22">Dul M</searchLink>; Cardiff School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK.<br /><searchLink fieldCode="AU" term="%22Alali+M%22">Alali M</searchLink>; World Health Organization, Geneva, Switzerland.<br /><searchLink fieldCode="AU" term="%22Ameri+M%22">Ameri M</searchLink>; Americeutics Consulting, USA; previously Zosano Pharma, USA.<br /><searchLink fieldCode="AU" term="%22Burke+MD%22">Burke MD</searchLink>; Stemline Therapeutics Inc, a Menarini Group Company, USA; previously Radius Health, Inc., USA.<br /><searchLink fieldCode="AU" term="%22Creelman+BP%22">Creelman BP</searchLink>; PATH, Seattle, USA.<br /><searchLink fieldCode="AU" term="%22Dick+L%22">Dick L</searchLink>; Previously Kindeva Drug Delivery, USA.<br /><searchLink fieldCode="AU" term="%22Donnelly+RF%22">Donnelly RF</searchLink>; School of Pharmacy, Queen's University Belfast, Belfast, UK.<br /><searchLink fieldCode="AU" term="%22Eakins+MN%22">Eakins MN</searchLink>; Eakins & Associates, USA.<br /><searchLink fieldCode="AU" term="%22Frivold+C%22">Frivold C</searchLink>; PATH, Seattle, USA.<br /><searchLink fieldCode="AU" term="%22Forster+AH%22">Forster AH</searchLink>; Vaxxas Pty Ltd, Australia.<br /><searchLink fieldCode="AU" term="%22Gilbert+PA%22">Gilbert PA</searchLink>; Bill & Melinda Gates Foundation, Seattle, USA.<br /><searchLink fieldCode="AU" term="%22Henke+S%22">Henke S</searchLink>; Bioaxxent - Drug Delivery, Germany; previously LTS Lohmann Therapie-Systeme AG, Germany.<br /><searchLink fieldCode="AU" term="%22Henry+S%22">Henry S</searchLink>; Micron Biomedical, Inc., USA.<br /><searchLink fieldCode="AU" term="%22Hunt+D%22">Hunt D</searchLink>; United States Pharmacopeia, USA.<br /><searchLink fieldCode="AU" term="%22Lewis+H%22">Lewis H</searchLink>; Previously Zosano Pharma, USA.<br /><searchLink fieldCode="AU" term="%22Mistilis+JJ%22">Mistilis JJ</searchLink>; PATH, Seattle, USA.<br /><searchLink fieldCode="AU" term="%22Park+JH%22">Park JH</searchLink>; Department of Bionano Technology, Gachon University, Seongnam, Republic of Korea.<br /><searchLink fieldCode="AU" term="%22Prausnitz+MR%22">Prausnitz MR</searchLink>; School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA.<br /><searchLink fieldCode="AU" term="%22Robinson+DK%22">Robinson DK</searchLink>; Bill & Melinda Gates Foundation, Seattle, USA.<br /><searchLink fieldCode="AU" term="%22Hernandez+CAR%22">Hernandez CAR</searchLink>; World Health Organization, Geneva, Switzerland.<br /><searchLink fieldCode="AU" term="%22Shin+J%22">Shin J</searchLink>; Raphas Co. Ltd, Republic of Korea.<br /><searchLink fieldCode="AU" term="%22Speaker+TJ%22">Speaker TJ</searchLink>; AbbVie Inc, USA.<br /><searchLink fieldCode="AU" term="%22Strasinger+C%22">Strasinger C</searchLink>; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), USA.<br /><searchLink fieldCode="AU" term="%22Taylor+KMG%22">Taylor KMG</searchLink>; University College London School of Pharmacy, UK; previously British Pharmacopoeia Commission, UK.<br /><searchLink fieldCode="AU" term="%22Zehrung+D%22">Zehrung D</searchLink>; Zehrung Global Health LLC, USA.<br /><searchLink fieldCode="AU" term="%22Birchall+JC%22">Birchall JC</searchLink>; Cardiff School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK.<br /><searchLink fieldCode="AU" term="%22Jarrahian+C%22">Jarrahian C</searchLink>; PATH, Seattle, USA.<br /><searchLink fieldCode="AU" term="%22Coulman+SA%22">Coulman SA</searchLink>; Cardiff School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK. Electronic address: coulmansa@cardiff.ac.uk.
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  Data: <searchLink fieldCode="JN" term="%228607908%22">Journal of controlled release : official journal of the Controlled Release Society</searchLink> [J Control Release] 2025 Feb 10; Vol. 378, pp. 402-415. <i>Date of Electronic Publication: </i>2024 Dec 20.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+Science+Publishers%22">Elsevier Science Publishers </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>8607908 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1873-4995 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2201683659%22">01683659 </searchLink><i>NLM ISO Abbreviation: </i>J Control Release <i>Subsets: </i>MEDLINE
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        Text: English
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