title: Issues impacting therapeutic outcomes in pediatric patients: an overview.
abstract: The quest for achieving optimal therapeutic outcomes in pediatric patients has evaded the healthcare professionals for long and often lack of child specific dosage forms and the associated events that follow with it have been considered to be major contributor towards suboptimal outcomes. Consequently, there have been sustained efforts over the years to address this issue with the enactment of legislations like Best Pharmaceutical for Children Act (BPCA), Pediatric Research Equity Act (PREA) and Pediatric Regulation by European Union (EU) to incentivise the participation of pharmaceutical industry towards development of child friendly dosage forms. Initiatives taken in past by organisations like World Health Organisation (WHO) and Drugs for Neglected Diseases Initiative (DNDi) to spur the development of child friendly dosage forms has helped to address issues pertaining to management of Human Immunodeficiency Virus (HIV) and malaria in pediatric patients. Present efforts aimed at developing child friendly dosage forms include oro-dispersible platforms including thin films and mini-tablets. Despite these leaps and advancements in developing better dosage forms for children, lower therapeutic outcomes in pediatric patients continue to remain an unresolved issue because of detrimental effects of additional factors such as parents understanding of label instructions and complexities involved in executing pediatric clinical studies thus requiring a concerted effort from pharmaceutical companies, academic researchers, parents and healthcare providers to work for better treatment outcomes in children.
authors.forename: Atin
authors.initials: A
authors.lastname: Kalra
authors.affiliation: University Institute of Pharmaceutical Sciences (UIPS), Panjab University, Chandigarh, India. shishugoindi@yahoo.co.in.
authors.forename: Shishu
authors.initials: S
authors.lastname: Goindi
mesh_terms: D019380:Anti-HIV Agents / Q000494:pharmacology*; D002648:Child; D002675:Child, Preschool; D004304:Dosage Forms / Q000592:standards*; D004333:Drug Administration Routes; D016503:Drug Delivery Systems; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D000431:Ethanol / Q000494:pharmacology / Q000633:toxicity; D019855:Ethylene Glycol / Q000494:pharmacology / Q000633:toxicity; D005079:Excipients / Q000494:pharmacology* / Q000633:toxicity; D005421:Flavoring Agents / Q000494:pharmacology; D006801:Humans; D007223:Infant; D010372:Pediatrics; D004364:Pharmaceutical Preparations / Q000592:standards; D019946:Propylene Glycol / Q000494:pharmacology / Q000633:toxicity; D013649:Taste
chemical_list: D019380:Anti-HIV Agents; D004304:Dosage Forms; D005079:Excipients; D005421:Flavoring Agents; D004364:Pharmaceutical Preparations; D000431:Ethanol; D019946:Propylene Glycol; D019855:Ethylene Glycol