Over the last couple of decades, the development of paediatric drugs has experienced unprecedented revolution, turning into a professionally oriented and scientifically challenging business. In the past, children were commonly called therapeutic orphans because most drugs were created and trialed on adults. Physicians in practice typically adjusted doses between adult and paediatric patients based on little evidence of safety, efficacy, or the right dose when treating paediatric patients. This was rather dangerous, since children are not just miniature adults; they are physiologically, metabolically, and biologically different. developmentally Paediatric drug development has made significant strides between 1995 and 2020 due to the advancement of scientific research, tougher regulatory standards and increased awareness on the ethical aspect of the necessity of child specific therapies. These advances prompted the development of more effective and safer, age-specific drug delivery systems suited to paediatric patients. However, there are still considerable obstacles, most of them connected with the biological diversity of the paediatric population itself. Infants, children, toddlers, and adolescents have unique physiological properties, such as differences in the maturation of the organs, enzyme activity, body composition, and immune functions. These variations affect the absorption, distribution, metabolism and excretion of drugs, and therefore the standard dosing methods are not suitable. To illustrate, infant liver and kidney immaturity may have considerable impact on drug metabolism and excretion, and variations in gastric pH and body water composition may impact on infant absorption and distribution. It is due to these developmental differences that age specific pharmacokinetic and Authors K Priya Dharshini Pharmaceutical Technology, Lab School of Chemical & Biotechnology SASTRA Deemed-to-be-University Thanjavur, Tamil Nadu, India. p.dharshi14@gmail.com Akshayaa Sankar Pharmaceutical Technology, Lab School of Chemical & Biotechnology SASTRA Deemed-to-be-University Thanjavur, Tamil Nadu, India. Vedha Hari B Narayanan Pharmaceutical Technology, Lab School of Chemical & Biotechnology SASTRA Deemed-to-be-University Thanjavur, Tamil Nadu, India. Ramya Devi D Pharmaceutical Technology Lab School of Chemical & Biotechnology SASTRA Deemed University Thanjavur, Tamil, Nadu, India. pharmacodynamic studies are required. But there are ethics and practice issues in clinical studies on paediatrics, such as the feasibility of blood sampling volumes and exposing children to experimental treatment. It follows that paediatric drug development must be supported by well-designed studies that are scientifically rigorous and ethically responsible. Knowledge of these issues and of the innovations that have been.