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FDA Modernization Act 2.0: An insight from nondeveloping country.
Akash, Sajidur Rahman; Arnob, M A Jobayer Billah; Uddin, Md Jamal.
Afiliación
  • Akash SR; Department of Pharmacy, Bangladesh University, Dhaka, Bangladesh.
  • Arnob MAJB; ABEx Bio-Research Center, East Azampur, Dhaka, Bangladesh.
  • Uddin MJ; Department of Biomedical Engineering, Chittagong University of Engineering & Technology, Chittagong, Bangladesh.
Drug Dev Res ; 84(8): 1572-1577, 2023 Dec.
Article en En | MEDLINE | ID: mdl-37587871
Animal testing is required in drug development research and is crucial for assessing the efficacy and safety of medications before they are commercialized. However, the newly furnished Food and Drug Administration Modernization Act 2.0 has given new insight into drug development. It opens a new door by offering an alternative testing method for developing a new drug without using animals. This newly proposed system may potentially significantly impact nondeveloped countries worldwide. In this study, we explore the alternative testing options such as in silico modeling, human tissue-on-chip engineering, animal-free recombinant antibodies, tissue engineering, and artificial intelligence presented by this act and discuss its implications for nondeveloped countries.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Inteligencia Artificial / Aprobación de Drogas Límite: Animals / Humans País/Región como asunto: America do norte Idioma: En Revista: Drug Dev Res Año: 2023 Tipo del documento: Article País de afiliación: Bangladesh

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Inteligencia Artificial / Aprobación de Drogas Límite: Animals / Humans País/Región como asunto: America do norte Idioma: En Revista: Drug Dev Res Año: 2023 Tipo del documento: Article País de afiliación: Bangladesh