Abstract
The rapid emergence of the crisis arising from antimicrobial resistance is posing a significant threat worldwide. Apart from careful antibiotic usage, this crisis also demands a consistent advancement in the regulations of antimicrobial drugs. Ever since the first approved antimicrobial drug, regulatory authorities for conducting clinical trials have issued several guidelines. These guidelines have been modified constantly to assess the efficacy, potency, dosage, and side effects of the drugs and are helpful in getting market approval for use against specific infectious diseases. Earlier, it was difficult to meet the regulatory standards earmarked for the trial design of antimicrobial drugs due to the demanding regulatory challenges. In order to overcome these challenges and to facilitate rapid and cost-effective development of novel antimicrobial drugs, the US Food and Drug Administration has made substantial improvements, including smaller trials and simplified patient enrolment. However, relaxation in clinical trials for antimicrobial drugs requires a high sample size to achieve reproducible and statistically significant results. In addition, it has been designed so that more attention is paid towards novel drug development strategies and designing clinical trials to gain more knowledge of antimicrobial drug profile and trial outcomes. These recent changes in regulatory guidelines have led to the smooth conduct of clinical development of novel antimicrobial drugs. Therefore, recent improvements in regulatory guidelines have lowered the barrier for the drugs under development, making it feasible for industries to meet the regulatory standards for creating a novel antimicrobial drug.
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Kumariya, S., Mehra, R., Kumariya, R. (2022). Regulations in Antimicrobial Drug Development: Challenges and New Incentives. In: Akhtar, N., Singh, K.S., Prerna, Goyal, D. (eds) Emerging Modalities in Mitigation of Antimicrobial Resistance. Springer, Cham. https://doi.org/10.1007/978-3-030-84126-3_8
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