Quality Requirements for Nanomedicines: From Early Development to the Market
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Nanomedicine and Nanotechnology".
Deadline for manuscript submissions: 30 June 2024 | Viewed by 1356
Special Issue Editors
Interests: nanostructured drug delivery systems; quality and safety assessment of nanomedicines; nonbiological complex drugs; vaccines and vaccine adjuvants; cancer research
Interests: nanoplatforms for brain and skin delivery; innovative biocompatible excipients; poorly water-soluble drugs; physicochemical/in vitro/in silico characterization methods; in vivo pharmacokinetics in rats
Special Issues, Collections and Topics in MDPI journals
2. Department of Pharmaceutical Technology and Cosmetology, University of Belgrade, Belgrade, Serbia
Interests: nano-enabled strategies for drug delivery; nanoemulsions; nanoparticles; physicochemical and in vitro characterization protocols; CQAs of nanocarriers; poorly soluble drugs/drug candidates
Special Issue Information
Dear Colleagues,
Nano-enabled medicinal products have been widely accepted in the field of biomedical innovation. Owing to their unique physicochemical properties, it has been expected that nanomedicines could meet specific health challenges. However, when compared to the extensive research activities in this field, the number of clinically approved nanomedicines is still rather limited. One of the reasons may be the lack of proper correlation of physicochemical properties with their biological effects. Another issue is reflected in the ambiguous regulation of these products and their case-by-case evaluation. Leading EU and US regulatory and scientific bodies have acknowledged that the lack of established methods to provide reliable preclinical data represents the bottleneck in the process of bringing promising nanomedicines to the market.
Therefore, this Special Issue aims to address some of the mentioned challenges and to collect pieces of knowledge on the performance of existing and new test methods and their application in the field of nanomedicine, targeting proper and reliable characterization of critical quality attributes and safety assessment of nanomedicines, supporting the regulatory decision making and facilitating the translation of these innovative products towards clinical applications.
In this Special Issue, both original research articles and reviews are welcome. Research areas may include (but not limited to) the following:
- Innovative formulation strategies of nano-enabled drug delivery systems
- Nanomedicines & Nanosimilars
- Methodological gaps in characterization of nanomedicines and nanocarriers
- Critical quality attributes (CQAs) of nanomedicines/nanocarriers
- Preclinical assessment of nanomedicines/nanocarriers
- Orthogonal & complementary techniques in nanomedicine development
- Bio-nano interactions
- Safety assessment of nanomedicines/nanocarriers
- Characterization protocols for nanomedicines (experimental setting, data interpretation)
- Pharmacokinetics of nanomedicines
- Biodistribution of nanomedicines and nanocarriers
- In vitro-(in silico)-in vivo correlation
- Nanomedicines and nanocarriers in clinical trials
We are pleased to invite researcher and other interested parties in the field of nanomedicines to contribute to the Pharmaceutics Special Issue Quality Requirements for Nanomedicines: From Early Development to the Market.
Prof. Dr. Gerrit Borchard
Prof. Dr. Snezana Savic
Dr. Ines Nikolić
Guest Editors
Manuscript Submission Information
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Keywords
- nanomedicines
- nanosimilars
- nanocarriers
- critical quality attributes
- orthogonality and complementarity
- protein corona
- quality assessment
- safety assessment
- bio-nano interactions
