Blood draws up to 3% of blood volume in clinical trials are safe in children-Reference-Cited by-同舟云学术

Blood draws up to 3% of blood volume in clinical trials are safe in children

Published:2018-10-30 Issue:5 Volume:108 Page:940-944
ISSN:0803-5253
Container-title:Acta Paediatrica
language:en
Short-container-title:Acta Paediatr

Author:

Peplow Claudia¹,Assfalg Robin¹,Beyerlein Andreas¹,Hasford Joerg²,Bonifacio Ezio³,Ziegler Anette‐G¹⁴^ORCID

Affiliation:

1. Institute of Diabetes Research Helmholtz Zentrum München and Forschergruppe Diabetes, Klinikum rechts der Isar Technische Universität München Neuherberg Germany

2. Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie Ludwig‐Maximilians‐Universität München Munich Germany

3. DFG Center for Regenerative Therapies Dresden Faculty of Medicine Technische Universität Dresden Dresden Germany

4. Forschergruppe Diabetes e.V. Neuherberg Germany

Publisher

Wiley

Subject

General Medicine,Pediatrics, Perinatology and Child Health

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/apa.14607

Reference7 articles.

1. European Parliament.Ethical considerations for clinical trials on medicinal products conducted with the paediatric population: Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use;2008. Available at:http://ec.europa.eu/health//sites/health/files/files/eudralex/vol-10/ethical_considerations_en.pdf.

2. The hospital for sick children (SickKids) Research Ethics Board. Blood Sampling Guidelines;2003. Available at:https://www.sickkids.ca/pdfs/Research/REB/12349-Bloodguidelines.pdf.

3. Invasiveness of pharmacokinetic studies in children: a systematic review

4. Blood sample volumes in child health research: review of safe limits

5. Warren Grant Magnuson Clinical Center.Policy and communications Bulletin – The Clinical Center/Medical Administrative Series: Guidelines for Limits of Blood Drawn for Research Purposes in the Clinical Center;2009. Available at:https://irb.research.chop.edu/sites/default/files/documents/g_nih_blooddraws.pdf.

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