IT IS TIME TO TAKE ADVANTAGE OF IN VITRO CELL BASED MODELS

Q4 Pharmacology, Toxicology and Pharmaceutics INDIAN DRUGS Pub Date : 2023-07-28 DOI:10.53879/id.60.07.p0005
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Abstract

Dear Reader, Preclinical tests are crucial for assessing the toxicity and safety of new drugs before moving on to evaluating their efficacy and immunogenicity. Animal models, as well as alternatives, have long been used to study human biology and pathology. However, animal experimentation has been restricted in recent years due to increasing complexities in animal usage and growing concerns about animal welfare groups. There have been ethical concerns raised about the unnecessary or excessive use of experimental animals. As a result, many jurisdictions, including the Indian government, the European Union (EU), the United States, Canada, and South Korea, have restricted usage of experimental animals. Another reason for the limitation of using animals in experiments is uncertainty of results. According to one study, 90% of experimental drugs fail clinical trials, implying that they do not accurately reflect human physiology. The Indian government recently amended the New Drugs and Clinical Trials 2023 (NDCT) Act aimed at fostering the replacement, reduction and refinement of animal testing and the use of non-animal and human-relevant methods to assess the safety and efficacy of new drugs.
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现在是利用体外细胞模型的时候了
在评估新药的有效性和免疫原性之前,临床前测试对于评估新药的毒性和安全性至关重要。长期以来,动物模型以及替代模型一直被用于研究人类生物学和病理学。然而,近年来由于动物使用的复杂性和对动物福利组织的日益关注,动物实验受到限制。人们对不必要或过度使用实验动物提出了伦理上的担忧。因此,包括印度政府、欧盟、美国、加拿大和韩国在内的许多司法管辖区都限制了实验动物的使用。限制用动物做实验的另一个原因是结果的不确定性。根据一项研究,90%的实验性药物在临床试验中失败,这意味着它们不能准确地反映人体生理。印度政府最近修订了《2023年新药和临床试验法》(NDCT),旨在促进替代、减少和改进动物试验,并使用与动物和人类无关的方法来评估新药的安全性和有效性。
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来源期刊
INDIAN DRUGS
INDIAN DRUGS Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
0.30
自引率
0.00%
发文量
98
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