Abbvie Inc, North Chicago, IL 60064, USA.
Pfizer Inc, Groton, CT 06340, USA.
Eur J Pharm Biopharm. 2021 Jul;164:66-74. doi: 10.1016/j.ejpb.2021.04.010. Epub 2021 Apr 18.
A pediatric formulation workshop entitled "Pediatric Formulations: Challenges of Today and Strategies for Tomorrow" was held to advance pediatric drug product development efforts in both pre-competitive and competitive environments. The workshop had four main sessions discussing key considerations of Formulation, Analytical, Clinical and Regulatory. This paper focuses on the clinical session of the workshop. It provides an overview of the discussion on the interconnection of pediatric formulation design and development, clinical development strategy and pediatric clinical pharmacology. The success of pediatric drug product development requires collaboration of multi-disciplinary teams across the pharmaceutical industry, consortiums, foundations, academia and global regulatory agencies. Early strategic planning is essential to ensure alignment among major stakeholders of different functional teams. Such an alignment is particularly critical in the collaboration between formulators and clinical pharmacology teams.
一个题为“儿科制剂：今天的挑战和明天的策略”的儿科制剂研讨会召开，旨在推进竞争前和竞争环境下的儿科药物产品开发工作。该研讨会有四个主要环节，分别讨论了制剂、分析、临床和监管方面的关键考虑因素。本文重点介绍研讨会的临床环节。它提供了一个概述，讨论了儿科制剂设计和开发、临床开发策略和儿科临床药理学之间的相互关系。儿科药物产品开发的成功需要制药行业、联盟、基金会、学术界和全球监管机构的多学科团队的合作。早期的战略规划对于确保不同职能团队的主要利益相关者之间的一致性至关重要。在制剂和临床药理学团队之间的合作中，这种一致性尤为关键。
