Harnessing formulation and clinical pharmacology knowledge for efficient pediatric drug development: Overview and discussions from M-CERSI pediatric formulation workshop 2019

Author:

Khong Yuet Mei,Liu Jing,Cook Jack,Purohit Vivek,Thompson Karen,Mehrotra Shailly,Cheung S.Y. Amy,Hay Justin L.,Fletcher Elimika Pfuma,Wang Jian,Sachs Hari Cheryl,Zhu Hao,Siddiqui Akhtar,Cunningham Lea,Selen Arzu

Funder

US Food and Drug Administration

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference40 articles.

1. D.C.T. Tan, Y.M. Khong, S. Mount, E. Galella, B. Mitra, S. Charlton, M. Kuhli, R. Ternik, J. Walsh, A. Rajapakshe, K. Thompson, S. Mehrotra, M. Santangelo, J. Liu, T. Dixit, D. Schaufelberger, S. Jamzad, S. Klein, S. W. Hoag, J. Wang, E. P. Fletcher, M. Khurana, J. Alexander, E. Radden, R. Sood, A. Selen, Pediatric Formulation Development - Challenges of Today and Strategies for Tomorrow: Summary Report from M-CERSI Workshop 2019, European Journal of Pharmaceutics and Biopharmaceutics (2021), in this issue.

2. University of Maryland School of Pharmacy. Agenda for Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow. Accessed on 12 October 2020. https://www.pharmacy.umaryland.edu/centers/cersievents/pediatric-formulations/agenda/ (2019).

3. European Commission. State of Paediatric Medicine in Europe: 10 years of the EU Pediatric Regulation, Report from the Commission to the European Parliament and the Council, COM (2017) 626. https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf.

4. USP General Chapter <795> Pharmaceutical Compounding – Non-sterile Preparations. https://www.usp.org/compounding/general-chapter-795, 2020. (accessed 19 May 2020).

5. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare, 2020. (accessed 22 May 2020).

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