TY - JOUR AU - Dobó, Dorina Gabriella AU - Németh, Zsófia AU - Sipos, Bence AU - Cseh, Martin AU - Pallagi, Edina AU - Berkesi, Dániel Simon AU - Kozma, Gábor AU - Kónya, Zoltán AU - Pannonhalminé Csóka, Ildikó TI - Pharmaceutical Development and Design of Thermosensitive Liposomes Based on the QbD Approach JF - MOLECULES J2 - MOLECULES VL - 27 PY - 2022 IS - 5 PG - 17 SN - 1420-3049 DO - 10.3390/molecules27051536 UR - https://m2.mtmt.hu/api/publication/32707423 ID - 32707423 N1 - Faculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u 6, Szeged, H-6720, Hungary Department of Applied and Environmental Chemistry, Faculty of Science and Informatics, Institute of Chemistry, University of Szeged, 1, Rerrich Béla tér, Szeged, H-6720, Hungary Cited By :1 Export Date: 28 November 2022 CODEN: MOLEF Correspondence Address: Dobó, D.G.; Faculty of Pharmacy, Eötvös u 6, Hungary; email: dobo.dorina.gabriella@szte.hu LA - English DB - MTMT ER - TY - CHAP AU - Németh, Zsófia AU - Reza, Semnani Jazani AU - Sipos, Bence AU - Dobó, Dorina Gabriella AU - Pallagi, Edina AU - Pannonhalminé Csóka, Ildikó ED - Uhljar, Luca Éva ED - Sipos, Bence TI - Risk-based optimization of liposome-based nano-carrier systems T2 - IV. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science : book of abstracts PB - University of Szeged CY - Szeged PY - 2022 SP - 44 EP - 44 PG - 1 DO - 10.14232/syrptbrs.2022.44 UR - https://m2.mtmt.hu/api/publication/32612795 ID - 32612795 LA - English DB - MTMT ER - TY - JOUR AU - Németh, Zsófia AU - Pallagi, Edina AU - Pannonhalminé Csóka, Ildikó TI - Gyógyszertechnológiai és regulációs kihívások. Megállapítások a neurológiai kórképek kezelésére szánt nazális liposzómás rezveratrol-tartalmú készítmény fejlesztése kapcsán TS - Megállapítások a neurológiai kórképek kezelésére szánt nazális liposzómás rezveratrol-tartalmú készítmény fejlesztése kapcsán JF - GYÓGYSZERÉSZET J2 - GYÓGYSZERÉSZET VL - 65 PY - 2021 IS - 12 SP - 724 EP - 734 PG - 11 SN - 0017-6036 UR - https://m2.mtmt.hu/api/publication/32547796 ID - 32547796 LA - Hungarian DB - MTMT ER - TY - JOUR AU - Pannonhalminé Csóka, Ildikó AU - Ismail, Ruba AU - Jójártné Laczkovich, Orsolya AU - Pallagi, Edina TI - Regulatory considerations, challenges and risk-based approach in nanomedicine development JF - CURRENT MEDICINAL CHEMISTRY J2 - CURR MED CHEM VL - 28 PY - 2021 IS - 36 SP - 7461 EP - 7476 PG - 16 SN - 0929-8673 DO - 10.2174/0929867328666210406115529 UR - https://m2.mtmt.hu/api/publication/32506114 ID - 32506114 N1 - Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Eötvös str. 6, Szeged, H-6720, Hungary Department of Applied and Environmental Chemistry, Institute of Chemistry, Faculty of Science and Informatics, University of Szeged, Rerrich Bela sq.1., Szeged, H-6720, Hungary Export Date: 23 November 2021 CODEN: CMCHE Correspondence Address: Ismail, R.; Institute of Pharmaceutical Technology and Regulatory Affairs, Eötvös str. 6, Hungary; email: ismail.ruba@pharm.u-szeged.hu AB - 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. LA - English DB - MTMT ER - TY - CONF AU - Katona, Gábor AU - Balogh, György Tibor AU - Dargó, Gergő AU - Gáspár, Róbert AU - Márki, Árpád AU - Ducza, Eszter AU - Sztojkov-Ivanov, Anita AU - Tömösi, Ferenc AU - Kecskeméti, Gábor AU - Janáky, Tamás AU - Kiss, Tamás AU - Ambrus, Rita AU - Pallagi, Edina AU - Révész, Piroska AU - Pannonhalminé Csóka, Ildikó ED - Malgorzata, Sznitowska TI - Quality by Design based formulation of intranasal meloxicam containing human serum albumin nanoparticles T2 - 13th Central European Symposium on Pharmaceutical Technology PB - Medical University of Gdansk C1 - Gdansk PY - 2021 SP - 71 EP - 71 PG - 1 UR - https://m2.mtmt.hu/api/publication/32475125 ID - 32475125 LA - English DB - MTMT ER - TY - JOUR AU - Németh, Zsófia AU - Pallagi, Edina AU - Dobó, Dorina Gabriella AU - Kozma, Gábor AU - Kónya, Zoltán AU - Pannonhalminé Csóka, Ildikó TI - An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development JF - PHARMACEUTICS J2 - PHARMACEUTICS VL - 13 PY - 2021 IS - 7 PG - 28 SN - 1999-4923 DO - 10.3390/pharmaceutics13071071 UR - https://m2.mtmt.hu/api/publication/32103865 ID - 32103865 N1 - Faculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6. Eötvös u, Szeged, H-6720, Hungary Department of Applied and Environmental Chemistry, Faculty of Science and Informatics, Institute of Chemistry, University of Szeged, 1, Rerrich Béla tér, Szeged, H-6720, Hungary Cited By :5 Export Date: 18 November 2022 Correspondence Address: Csóka, I.; Faculty of Pharmacy, 6. Eötvös u, Hungary; email: csoka.ildiko@szte.hu LA - English DB - MTMT ER - TY - GEN AU - Németh, Zsófia AU - Dobó, Dorina Gabriella AU - Pallagi, Edina AU - Pannonhalminé Csóka, Ildikó TI - Quality by Design-based development process for preparation of liposomal formulations PY - 2021 UR - https://m2.mtmt.hu/api/publication/32026776 ID - 32026776 LA - English DB - MTMT ER - TY - JOUR AU - Sabir, Fakhara AU - Katona, Gábor AU - Pallagi, Edina AU - Dobó, Dorina Gabriella AU - Akel, Hussein AU - Berkesi, Dániel Simon AU - Kónya, Zoltán AU - Pannonhalminé Csóka, Ildikó TI - Quality-by-Design-Based Development of n-Propyl-Gallate-Loaded Hyaluronic-Acid-Coated Liposomes for Intranasal Administration JF - MOLECULES J2 - MOLECULES VL - 26 PY - 2021 IS - 5 PG - 22 SN - 1420-3049 DO - 10.3390/molecules26051429 UR - https://m2.mtmt.hu/api/publication/31910259 ID - 31910259 LA - English DB - MTMT ER - TY - JOUR AU - Németh, Zsófia AU - Pallagi, Edina AU - Dobó, Dorina Gabriella AU - Pannonhalminé Csóka, Ildikó TI - How could QbD address the R&D challenges of ‘nose-to-brain’ liposomal resveratrol formulations? JF - PROCEEDINGS J2 - PROCEEDINGS VL - 78 PY - 2021 IS - 1 PG - 8 SN - 2504-3900 DO - 10.3390/IECP2020-08661 UR - https://m2.mtmt.hu/api/publication/31856313 ID - 31856313 LA - English DB - MTMT ER - TY - CHAP AU - Németh, Zsófia AU - Dobó, Dorina Gabriella AU - Pallagi, Edina AU - Pannonhalminé Csóka, Ildikó ED - Uhljar, Luca Éva TI - Quality-focused formulation - QbD-based liposome design and development T2 - III. Symposium of Young Researchers on Pharmaceutical Technology, Biotechnology and Regulatory Science PB - Szegedi Tudományegyetem (SZTE) CY - Szeged PY - 2021 SP - 22 EP - 22 PG - 1 DO - 10.14232/syrptbrs.2021.op10 UR - https://m2.mtmt.hu/api/publication/31856300 ID - 31856300 LA - English DB - MTMT ER -