Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper

Author:

Walsh Jennifer1,Schaufelberger Daniel2,Iurian Sonia3,Klein Sandra4,Batchelor Hannah5,Turner Roy6,Gizurarson Sveinbjörn7,Boltri Luigi8,Alessandrini Elisa9,Tuleu Catherine9ORCID

Affiliation:

1. BioCity Nottingham Jenny Walsh Consulting Ltd Nottingham UK

2. School of Medicine, All Children's Hospital Schaufelberger Consulting LLC and Johns Hopkins University St. Petersburg FL USA

3. Department of Pharmaceutical Technology and Biopharmacy Iuliu Haţieganu University of Medicine and Pharmacy Cluj‐Napoca Romania

4. Department of Pharmacy, Institute of Biopharmaceutics and Pharmaceutical Technology University of Greifswald Greifswald Germany

5. Strathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow UK

6. Idorsia Pharmaceuticals Ltd Allschwil Switzerland

7. Faculty of Pharmaceutical Sciences, University of Iceland, Reykjavik, Iceland; and Pharmacy Department Kamuzu University of Health Sciences Blantyre Malawi

8. Pharmaceutical Development Adare Pharmaceuticals Milan Italy

9. University College London School of Pharmacy London UK

Funder

Horizon 2020 Framework Programme

European Commission

Innovative Medicines Initiative

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference108 articles.

1. European Medicines Agency (EMA).Examples of key binding elements in the PIP decisions. EMA/174403/2013 Human Medicines Development and Evaluation. Published 2013.https://www.ema.europa.eu/en/documents/other/examples-key-binding-elements-paediatric-investigation-plan-decisions_en.pdf. Accessed March 12 2021.

2. Pediatric Oral Formulations: An Updated Review of Commercially Available Pediatric Oral Formulations Since 2007

3. World Health Organisation Unitaid.Innovative Delivery Systems for Paediatric Medicines: Technology Landscape. Published online 2020.https://unitaid.org/assets/Innovative-delivery-systems-for-paediatric-medicines-technology-landscape.pdf

4. European Medicines Agency (EMA).Evidence of harm from off‐label or unlicensed medicines in children EMEA/126327/2004. Published 2004.https://www.ema.europa.eu/en/documents/other/evidence-harm-label-unlicensed-medicines-children_en.pdf. Accessed March 12 2021.

5. How to ensure the quality and safety of unlicensed oral medicines;Lowey A;Pharm J,2008

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