Pediatric formulation development – Challenges of today and strategies for tomorrow: Summary report from M−CERSI workshop 2019

Autor: Daniel Schaufelberger, Asha Rajapakshe, Stephen W. Hoag, Matthew Santangelo, Jing Liu, Ramesh Sood, Trupti Dixit, Steven Mount, Erica Radden, Karen C. Thompson, Mona Khurana, Shailly Mehrotra, Jian Wang, Biplob Mitra, Jamzad Shahla, Sandra Klein, John J. Alexander, Maren Kuhli, Robert Louis Ternik, Jennifer Walsh, Arzu Selen, Yuet Mei Khong, Elizabeth Galella, Stuart Charlton, David Cheng Thiam Tan, Elimika Pfuma Fletcher
Rok vydání: 2021
Předmět:
Zdroj: European Journal of Pharmaceutics and Biopharmaceutics. 164:54-65
ISSN: 0939-6411
DOI: 10.1016/j.ejpb.2021.04.011
Popis: 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.
Databáze: OpenAIRE
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