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Интеллектуальная Система Тематического Исследования НАукометрических данных |
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A Design-Conversed Strategy Establishes the Performance Safe Space for Doxorubicin Nanosimilarsстатья
Статья опубликована в высокорейтинговом журнале
Статья опубликована в журнале из списка Web of Science и/или Scopus- Авторы: Nagpal Shakti, Png Yi Jie Jordan, Malinovskaya Julia, Kovshova Tatyana, Jain Pankaj, Naik Sachin, Khopade Ajay, Bhowmick Subhas, Shahi Pradeep, Chakra Amaresh, Bhokari Ashutosh, Shah Vishal, Gelperina Svetlana, Wacker Matthias G.
- Журнал: ACS Nano
- Год издания: 2024
- Издательство: American Chemical Society
- Местоположение издательства: United States
- DOI: 10.1021/acsnano.3c08290
- Аннотация: Nanomedicines exhibit multifaceted performances, yet their biopharmaceutics remain poorly understood and present several challenges in the translation from preclinical to clinical research. To address this issue and promote the production of high-quality nanomedicines, a systematic screening of the design space and in vivo performance is necessary. Establishing formulation performance specifications early on enables an informed selection of candidates and promotes the development of nanosimilars. The deconvolution of the pharmacokinetics enables the identification of key characteristics that influence their performances and disposition. Using an in vitro-in vivo rank-order relationship for doxorubicin nanoformulations, we defined in vitro release specifications for Doxil/Caelyx-like follow-on products. Additionally, our model predictions were used to establish the bioequivalence of Lipodox, a nanosimilar of Doxil/Caelyx. Furthermore, a virtual safe space was established, providing crucial insights into expected disposition kinetics and informing formulation development. By addressing bottlenecks in biopharmaceutics and formulation screening, our research advances the translation of nanomedicine from bench to bedside.
- Добавил в систему: Ковшова Татьяна Сергеевна