Global Pediatric Regulations: An Overview.

Autor: Gadge PM; 1 Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune, Maharashtra, India., Kenjale PP; 2 Department of Pharmaceutics, BVDU Poona College of Pharmacy, Pune, Maharashtra, India., Pokharkar VB; 2 Department of Pharmaceutics, BVDU Poona College of Pharmacy, Pune, Maharashtra, India., Gaikwad VL; 2 Department of Pharmaceutics, BVDU Poona College of Pharmacy, Pune, Maharashtra, India.
Jazyk: angličtina
Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2019 Jul 28, pp. 2168479019864090. Date of Electronic Publication: 2019 Jul 28.
DOI: 10.1177/2168479019864090
Abstrakt: The purpose of the present review is to summarize the current pediatric regulatory requirements and also the regulatory efforts that need to be taken for the potential benefits of safety and efficacy to the pediatric patients. The importance of pediatric regulations came into existence as adult physiological conditions differ from that of children; therefore, the same dosage regimen cannot be recommended for both. Children deviate from adults with respect to pharmacokinetic and pharmacodynamic characteristics, and hence the effect of the drug has to be reconfirmed for pediatrics. Drugs used in pediatric clinics are often considered as "therapeutic orphans" throughout the world as they are difficult to develop and are not provided with sufficient information. The number of clinical trials performed in children is not sufficient. At present, laws and regulations aimed at drug development in the pediatric field have not been focused significantly. There are different regulatory bodies that administrate the pediatric regulations for a particular region.
Databáze: MEDLINE
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