Challenges and Planning of Pediatric Clinical Trials: an Overview(Pages 29-36)
Sutapa Biswas Majee1, Soupayan Pal1, Dipanjana Ash2 and Gopa Roy Biswas1
1Department of Pharmacy, NSHM Knowledge Campus, Kolkata-Group of Institutions, 124 B.L.Saha Road, Kolkata- 700053, West Bengal, India; 2Department of Pharmaceutical Technology, Brainware University, 398, Ramkrishnapur Road, Barasat, Kolkata- 700125, West Bengal, India
Abstract: Children should be considered different from adults in terms of pharmacodynamic and pharmacokinetic effects associated with administered drugs. There is still a paucity of robust data in children on safety and efficacy of medicines giving rise to either sub-optimum therapeutic effect or unknown harmful side effects. Strict governance by regulatory authorities worldwide has necessitated formulation development of age-appropriate, safe and effective medicines specifically for children. The current review covers logistical and methodological challenges, major steps in planning and conduct of bioavailability-bioequivalence studies in children and pediatric clinical trial. It aims to provide knowledge that will fulfill the goal of optimised pediatric pharmacotherapy will heighten the possibilities of public funding and industry sponsorship and facilitate implementation of the present regulations and initiatives thereby improving the scope, reliability and relevance of clinical trials in pediatric population. Close integration between validated clinical research and patient care will foster low risk therapy for the highly vulnerable therapeutic population.
Keywords: Bioavailability-bioequivalence (BA-BE), BCS, Clinical trial, Pediatric, Population pharmacokinetics.