@article{MTMT:32707423,
	title = {Pharmaceutical Development and Design of Thermosensitive Liposomes Based on the QbD Approach},
	url = {https://m2.mtmt.hu/api/publication/32707423},
	author = {Dobó, Dorina Gabriella and Németh, Zsófia and Sipos, Bence and Cseh, Martin and Pallagi, Edina and Berkesi, Dániel Simon and Kozma, Gábor and Kónya, Zoltán and Pannonhalminé Csóka, Ildikó},
	doi = {10.3390/molecules27051536},
	journal-iso = {MOLECULES},
	journal = {MOLECULES},
	volume = {27},
	unique-id = {32707423},
	issn = {1420-3049},
	year = {2022},
	eissn = {1420-3049},
	orcid-numbers = {Németh, Zsófia/0000-0003-3953-9831; Sipos, Bence/0000-0002-0131-4728; Kozma, Gábor/0000-0003-2033-0720; Kónya, Zoltán/0000-0002-9406-8596; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}

@{MTMT:32612795,
	title = {Risk-based optimization of liposome-based nano-carrier systems},
	url = {https://m2.mtmt.hu/api/publication/32612795},
	author = {Németh, Zsófia and Reza, Semnani Jazani and Sipos, Bence and Dobó, Dorina Gabriella and Pallagi, Edina and Pannonhalminé Csóka, Ildikó},
	booktitle = {IV. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science : book of abstracts},
	doi = {10.14232/syrptbrs.2022.44},
	unique-id = {32612795},
	year = {2022},
	pages = {44-44},
	orcid-numbers = {Németh, Zsófia/0000-0003-3953-9831; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}

@article{MTMT:32547796,
	title = {Gyógyszertechnológiai és regulációs kihívások. Megállapítások a neurológiai kórképek kezelésére szánt nazális liposzómás rezveratrol-tartalmú készítmény fejlesztése kapcsán},
	url = {https://m2.mtmt.hu/api/publication/32547796},
	author = {Németh, Zsófia and Pallagi, Edina and Pannonhalminé Csóka, Ildikó},
	journal-iso = {GYÓGYSZERÉSZET},
	journal = {GYÓGYSZERÉSZET},
	volume = {65},
	unique-id = {32547796},
	issn = {0017-6036},
	year = {2021},
	pages = {724-734},
	orcid-numbers = {Németh, Zsófia/0000-0003-3953-9831; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}

@article{MTMT:32506114,
	title = {Regulatory considerations, challenges and risk-based approach in nanomedicine development},
	url = {https://m2.mtmt.hu/api/publication/32506114},
	author = {Pannonhalminé Csóka, Ildikó and Ismail, Ruba and Jójártné Laczkovich, Orsolya and Pallagi, Edina},
	doi = {10.2174/0929867328666210406115529},
	journal-iso = {CURR MED CHEM},
	journal = {CURRENT MEDICINAL CHEMISTRY},
	volume = {28},
	unique-id = {32506114},
	issn = {0929-8673},
	abstract = {The translation of nanomedicines from the lab level into marketed product faces several challenges, including characterization of physicochemical properties, phar-macodynamics, pharmacokinetics, process control, biocompatibility, and nanotoxicity, scaling-up as well as reproducibility. The challenges of nanomedicine development are in connection with the different requirements from the patient (clinical and therapeutic use), industry (production), and regulatory bodies (authorization process). This paper aims at reviewing the status and regulatory aspects of nano-based drug delivery systems with a focus on the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) regulations. In addition to discussing the risks accompanied by the development of nanomedicine, the potential of following a risk-based methodology from the early stage of the R&D phase is emphasized here to ensure safety and efficacy when developing novel nano-based dosage forms. The R&D of nanomedicines is a complex and multidisciplinary approach, and there are still many challenges in their regulation and leg-islation. In general, the most critical considerations for nanomedicines are the product quality assessment (physicochemical characteristics, quality control, manufacturing pro-cess) and product safety assessment (pharmacokinetics, biodegradation, accumulation, and nanotoxicity). The paper presents a promising paradigm in the development and mar-keting authorization of nanomedicines, namely the Quality by Design (QbD) approach. Sufficient knowledge on the quality, safety, and efficacy of nanomedicines is necessary to obtain a significant focus on establishing robust, standardized methods for evaluating the critical quality attributes of nanomedicines. The QbD-based submission is highly rec-ommended and required by the regulatory authorities, enabling a smooth clinical translation of the novel nanomedicines. © 2021 Bentham Science Publishers.},
	keywords = {drug development; Nanomedicine; quality by design (QbD); Food and Drug Administration (FDA); European Medicine Agency (EMA); Nanotoxici-ty; Risk Assessment (RA)},
	year = {2021},
	eissn = {1875-533X},
	pages = {7461-7476},
	orcid-numbers = {Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781; Ismail, Ruba/0000-0002-5122-9513}
}

@CONFERENCE{MTMT:32475125,
	title = {Quality by Design based formulation of intranasal meloxicam containing human serum albumin nanoparticles},
	url = {https://m2.mtmt.hu/api/publication/32475125},
	author = {Katona, Gábor and Balogh, György Tibor and Dargó, Gergő and Gáspár, Róbert and Márki, Árpád and Ducza, Eszter and Sztojkov-Ivanov, Anita and Tömösi, Ferenc and Kecskeméti, Gábor and Janáky, Tamás and Kiss, Tamás and Ambrus, Rita and Pallagi, Edina and Révész, Piroska and Pannonhalminé Csóka, Ildikó},
	booktitle = {13th Central European Symposium on Pharmaceutical Technology},
	unique-id = {32475125},
	year = {2021},
	pages = {71-71},
	orcid-numbers = {Katona, Gábor/0000-0003-1564-4813; Balogh, György Tibor/0000-0003-3347-1880; Dargó, Gergő/0000-0002-1141-8379; Gáspár, Róbert/0000-0002-1571-7579; Márki, Árpád/0000-0002-6056-8891; Tömösi, Ferenc/0000-0002-6657-5777; Kecskeméti, Gábor/0000-0002-5584-6869; Janáky, Tamás/0000-0002-6466-8283; Kiss, Tamás/0000-0003-0011-0501; Révész, Piroska/0000-0002-5336-6052; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}

@article{MTMT:32103865,
	title = {An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development},
	url = {https://m2.mtmt.hu/api/publication/32103865},
	author = {Németh, Zsófia and Pallagi, Edina and Dobó, Dorina Gabriella and Kozma, Gábor and Kónya, Zoltán and Pannonhalminé Csóka, Ildikó},
	doi = {10.3390/pharmaceutics13071071},
	journal-iso = {PHARMACEUTICS},
	journal = {PHARMACEUTICS},
	volume = {13},
	unique-id = {32103865},
	issn = {1999-4923},
	year = {2021},
	eissn = {1999-4923},
	orcid-numbers = {Németh, Zsófia/0000-0003-3953-9831; Kozma, Gábor/0000-0003-2033-0720; Kónya, Zoltán/0000-0002-9406-8596; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}

@misc{MTMT:32026776,
	title = {Quality by Design-based development process for preparation of liposomal formulations},
	url = {https://m2.mtmt.hu/api/publication/32026776},
	author = {Németh, Zsófia and Dobó, Dorina Gabriella and Pallagi, Edina and Pannonhalminé Csóka, Ildikó},
	unique-id = {32026776},
	year = {2021},
	orcid-numbers = {Németh, Zsófia/0000-0003-3953-9831; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}

@article{MTMT:31910259,
	title = {Quality-by-Design-Based Development of n-Propyl-Gallate-Loaded Hyaluronic-Acid-Coated Liposomes for Intranasal Administration},
	url = {https://m2.mtmt.hu/api/publication/31910259},
	author = {Sabir, Fakhara and Katona, Gábor and Pallagi, Edina and Dobó, Dorina Gabriella and Akel, Hussein and Berkesi, Dániel Simon and Kónya, Zoltán and Pannonhalminé Csóka, Ildikó},
	doi = {10.3390/molecules26051429},
	journal-iso = {MOLECULES},
	journal = {MOLECULES},
	volume = {26},
	unique-id = {31910259},
	issn = {1420-3049},
	year = {2021},
	eissn = {1420-3049},
	orcid-numbers = {Sabir, Fakhara/0000-0002-4369-1599; Katona, Gábor/0000-0003-1564-4813; Akel, Hussein/0000-0003-4453-9545; Kónya, Zoltán/0000-0002-9406-8596; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}

@article{MTMT:31856313,
	title = {How could QbD address the R&D challenges of ‘nose-to-brain’ liposomal resveratrol formulations?},
	url = {https://m2.mtmt.hu/api/publication/31856313},
	author = {Németh, Zsófia and Pallagi, Edina and Dobó, Dorina Gabriella and Pannonhalminé Csóka, Ildikó},
	doi = {10.3390/IECP2020-08661},
	journal-iso = {PROCEEDINGS},
	journal = {PROCEEDINGS},
	volume = {78},
	unique-id = {31856313},
	year = {2021},
	eissn = {2504-3900},
	orcid-numbers = {Németh, Zsófia/0000-0003-3953-9831; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}

@{MTMT:31856300,
	title = {Quality-focused formulation - QbD-based liposome design and development},
	url = {https://m2.mtmt.hu/api/publication/31856300},
	author = {Németh, Zsófia and Dobó, Dorina Gabriella and Pallagi, Edina and Pannonhalminé Csóka, Ildikó},
	booktitle = {III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science},
	doi = {10.14232/syrptbrs.2021.op10},
	unique-id = {31856300},
	year = {2021},
	pages = {22-22},
	orcid-numbers = {Németh, Zsófia/0000-0003-3953-9831; Pallagi, Edina/0000-0002-8039-2109; Pannonhalminé Csóka, Ildikó/0000-0003-0807-2781}
}