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Regulatory aspects on drug development for pediatric Populations

N.V.V.S. Swami*, D. Raghava
*Department of Regulatory affairs, K.G.R.L College of Pharmacy,  Bhimavaram, Andhrapradesh

Volume-12, Issue-1, January 2024, 4637 | Full article PDF
A. J. Med. Pharm, Sci., 2024, 12(1): 26-29
DOI: https://doi.org/10.30904/j.ajmps.2024.4637

A b s t r a c t
The study aimed to investigate the current regulations guarding the approval and maintenance of the pediatric drugs. This review gives an overview of the regulatory aspects for pediatric drug development and their influence on practical and scientific considerations when conducting clinical studies in children. M&S as an efficient means to extract knowledge from the data will be discussed subsequently, rounding off the process of pediatric study planning, conduct, and evaluation. Numerous regulatory documents are available to guide pharmaceutical companies through the specific procedures and to answer specific scientific questions regarding study design and conduct. Since pediatric drug development is a very complex area, many questions remain open, and close collaboration and communication between industry and health authorities is essential. Numerous regulatory documents are available to guide pharmaceutical companies through the specific procedures and to answer specific scientific questions regarding study design and conduct. Since pediatric drug development is a very complex area, many questions remain open, and close collaboration and communication between industry and health authorities is essential. The paediatric population requires special considerations for prescription of medicines due to their under developed physiologic systems. Any negligence of this very aspect can lead to often deleterious side effects. For these very reasons there is a need to develop guidelines and regulations in India, similar to other regulated and emerging markets, for the welfare of the paediatric population.
Keywords: Paediatric population, regulatory documents, pediatric drugs, U.S. and E.U.

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