Department of Clinical Pharmacology, Pfizer, Inc., Groton, Connecticut 06340, USA.
AAPS J. 2012 Sep;14(3):519-22. doi: 10.1208/s12248-012-9364-3. Epub 2012 May 5.
Pediatric drug development is a required consideration for all drug development programs. Age-appropriate formulations such as suspensions, chewable tablets, oral disintegrating tablets, etc., are typically developed and used in the pediatric clinical studies. However, it is not uncommon to use enabling formulations in the pivotal pediatric clinical study followed by bridging bioavailability and/or bioequivalence studies. Development of age-appropriate formulations is an essential part of pediatric drug development and adds additional biopharmaceutical considerations to an already complex problem. Careful planning of biopharmaceutic data collection during the adult and pediatric development program can contribute significantly to the biopharmaceutic risk assessment and planning of appropriate clinical studies leading to successful development of pediatric formulations.
儿科药物开发是所有药物开发项目的必要考虑因素。通常会开发和使用适合年龄的制剂，如混悬剂、咀嚼片、口腔崩解片等，用于儿科临床研究。然而，在关键性儿科临床研究中使用赋形剂并不罕见，随后进行生物利用度和/或生物等效性桥接研究。开发适合年龄的制剂是儿科药物开发的重要组成部分，为已经复杂的问题增加了额外的生物药剂学考虑因素。在成人和儿科开发项目中仔细规划生物药剂学数据的收集，可以显著有助于生物药剂学风险评估和规划适当的临床研究，从而成功开发儿科制剂。
