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

Autor: 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.

Publikováno v: Journal of controlled release : official journal of the Controlled Release Society [J Control Release] 2024 Dec 20; Vol. 378, pp. 402-415. Date of Electronic Publication: 2024 Dec 20.

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Hydrodynamic gene delivery in human skin using a hollow microneedle device

Autor: Dul, M, Stefanidou, M, Porta, P, Serve, J, O'Mahony, C, Malissen, B, Henri, S, Levin, Y, Kochba, E, Wong, FS, Dayan, C, Coulman, SA, Birchall, JC

Publikováno v: In Journal of Controlled Release 10 November 2017 265:120-131

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Assessing the risk of a clinically significant infection from a Microneedle Array Patch (MAP) product.

Autor: 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., Burke MD; Stemline Therapeutics Inc, A Menarini Group Company, USA., Craig CM; ValSource, Inc., USA., Creelman BP; PATH, Seattle, USA., Dick L; 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 and Melinda Gates Foundation, Seattle, USA., Henke S; Dr. Stefan Henke Pharma Consulting, Germany., Henry S; Micron Biomedical, Inc., USA., Hunt D; United States Pharmacopeia, USA., Lewis H; Zosano Pharma, USA., Maibach HI; Department of Dermatology, University of California San Francisco, San Francisco, CA, 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 and Melinda Gates Foundation, Seattle, USA., Hernandez CAR; World Health Organization, Geneva, Switzerland., Ross C; Vaxxas Pty Ltd., Australia., Shin J; Raphas Co. Ltd, Republic of Korea., Speaker TJ; AbbVie, Inc., USA., Taylor KM; University College London School of Pharmacy, British Pharmacopoeia Commission, UK., Zehrung D; PharmaJet, Inc., 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.

Publikováno v: Journal of controlled release : official journal of the Controlled Release Society [J Control Release] 2023 Sep; Vol. 361, pp. 236-245. Date of Electronic Publication: 2023 Aug 08.