Department of Pharmacy, Bangladesh University, Dhaka, Bangladesh.
ABEx Bio-Research Center, East Azampur, Dhaka, Bangladesh.
Drug Dev Res. 2023 Dec;84(8):1572-1577. doi: 10.1002/ddr.22108. Epub 2023 Aug 17.
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.
动物试验是药物开发研究中必需的,对于评估药物在商业化之前的疗效和安全性至关重要。然而,新出台的《食品和药物管理局现代化法案 2.0》为药物开发提供了新的视角。它通过提供一种新的药物开发替代测试方法,为不使用动物开发新药开辟了新的途径。这个新提出的系统可能会对全球欠发达国家产生重大影响。在这项研究中,我们探讨了该法案提出的替代测试选项,如计算机模拟、人类组织芯片工程、无动物重组抗体、组织工程和人工智能,并讨论了其对欠发达国家的影响。