AbbVie Inc., North Chicago, IL, United States.
AbbVie Inc., North Chicago, IL, United States.
Eur J Pharm Biopharm. 2021 Jul;164:54-65. doi: 10.1016/j.ejpb.2021.04.011. Epub 2021 Apr 18.
A workshop on "Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow" was organized jointly by the University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI), the U.S. Food and Drug Administration (FDA) and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Drug Product Pediatric Working Group (PWG). This multi-disciplinary, pediatric focused workshop was held over a two-day period (18-19 Jun 2019) and consisted of participants from industry, regulatory agencies, academia and other organizations from both US and Europe. The workshop consisted of sequential sessions on formulation, analytical, clinical, and regulatory and industry lessons learned and future landscape. Each session began with a series of short framing presentations, followed by facilitated breakout sessions and panel discussion. The formulation session was dedicated to three main topics pertaining to drug product acceptability, excipients in pediatrics and oral administration device considerations. The analytical session discussed key considerations for dosing vehicle selection and analytical strategies for testing of different dosage forms, specifically mini-tablets (multiparticulates). The clinical session highlighted the influence of pediatric pharmacokinetics prediction on formulation design, pediatric drug development strategies and clinical considerations to support pediatric formulation design. The regulatory and industry lessons learned and future landscape session explored the regional differences that exist in regulatory expectations, requirements for pediatric formulation development, and key patient-centric factors to consider when developing novel pediatric formulations. This session also discussed potential collaboration opportunities and tools for pediatric formulation development. This manuscript summarizes the key discussions and outcomes of all the sessions in the workshop with a broadened review and discussion of the topics that were covered.
一个关于“儿科制剂开发：今天的挑战和明天的策略”的研讨会是由马里兰大学卓越监管科学与创新中心（M-CERSI）、美国食品和药物管理局（FDA）和国际药品开发创新质量联盟（IQ）药物产品儿科工作组（PWG）联合举办的。这个多学科、以儿科为重点的研讨会为期两天（2019 年 6 月 18 日至 19 日），参与者来自美国和欧洲的工业界、监管机构、学术界和其他组织。研讨会由制剂、分析、临床、监管和工业经验教训以及未来前景等一系列会议组成。每个会议都从一系列简短的框架介绍开始，然后是分组讨论和小组讨论。制剂会议专门讨论了与药物产品可接受性、儿科中的赋形剂和口服给药装置考虑因素有关的三个主要主题。分析会议讨论了选择给药载体和测试不同剂型（特别是迷你片剂（多颗粒））的分析策略的关键考虑因素。临床会议强调了儿科药代动力学预测对制剂设计、儿科药物开发策略和支持儿科制剂设计的临床考虑因素的影响。监管和工业经验教训和未来前景会议探讨了监管期望、儿科制剂开发要求以及开发新型儿科制剂时需要考虑的关键以患者为中心的因素方面存在的区域差异。本会议还讨论了儿科制剂开发的潜在合作机会和工具。本文总结了研讨会所有会议的关键讨论和结果，并对涵盖的主题进行了更广泛的回顾和讨论。
