TY - JOUR
T1 - Pediatric formulation development – Challenges of today and strategies for tomorrow
T2 - Summary report from M−CERSI workshop 2019
AU - Tan, David Cheng Thiam
AU - Khong, Yuet Mei
AU - Mount, Steven
AU - Galella, Elizabeth
AU - Mitra, Biplob
AU - Charlton, Stuart
AU - Kuhli, Maren
AU - Ternik, Robert
AU - Walsh, Jennifer
AU - Rajapakshe, Asha
AU - Thompson, Karen
AU - Mehrotra, Shailly
AU - Santangelo, Matthew
AU - Liu, Jing
AU - Dixit, Trupti
AU - Schaufelberger, Daniel
AU - Jamzad, Shahla
AU - Klein, Sandra
AU - Hoag, Stephen W.
AU - Wang, Jian
AU - Fletcher, Elimika Pfuma
AU - Khurana, Mona
AU - Alexander, John
AU - Radden, Erica
AU - Sood, Ramesh
AU - Selen, Arzu
N1 - Publisher Copyright:
© 2021 Elsevier B.V.
PY - 2021/7
Y1 - 2021/7
N2 - 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.
AB - 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.
KW - Acceptability
KW - Children
KW - Clinical
KW - Device
KW - Dosing vehicles
KW - Excipients
KW - Mini-tablets
KW - Multiparticulates
KW - Pediatric formulations
KW - Regulatory
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U2 - 10.1016/j.ejpb.2021.04.011
DO - 10.1016/j.ejpb.2021.04.011
M3 - Article
C2 - 33878432
AN - SCOPUS:85107088464
SN - 0939-6411
VL - 164
SP - 54
EP - 65
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
ER -