European Journal of Biomedical and Pharmaceutical Sciences

POSOLOGY: DRUG DEVELOPMENT IN PEDIATRICS

Dr. Virendra Kushwaha, Dr. Pooja Agrawal*, Dr. Nasreen Fatma Khan and Dr. Tanvi Azmi

ABSTRACT

Reluctance to enroll pediatric subjects in clinical trials has left gaps in information about the dosing, safety, and efficacy of medications. A pediatric population is a diverse group comprising different subgroups and liquids being the most preferred dosage form for children, especially of lower age. However, in the absence of suitable or labeled dosage forms, the use of unlicensed and off-label non-standard formulations that are devoid of relevant scientific data and hence pose a high risk to pediatric patients. The approach to pediatric drug dosing needs to be based on the physiological characteristics of the child and the pharmacokinetic parameters of the drug. This review summarises the current knowledge on developmental changes in absorption, distribution, metabolism, and excretion and combines this knowledge with in vivo and in vitro pharmacokinetic data that are currently available for the ultimate goal of providing infants and children with safe and effective drug therapy and will be made possible by specifically including them in clinical trials. Guidelines formed are intended to be used in clinical practice and to form a basis for more research. Also, the integration of these guidelines, and combining them with pharmacodynamic effects, should be considered and could form a basis for further study.

Keywords: Pediatric, dosage form, pharmacokinetic, pharmacodynamic.