Challenges and considerations for development of therapeutic proteins in pediatric patients

Author:

Zhang Yi12,Wei Xiaohui3,Bajaj Gaurav4,Barrett Jeffrey S.5,Meibohm Bernd6,Joshi Amita3,Gupta Manish14

Affiliation:

1. Former employee of Clinical Pharmacology; Genentech; South San Francisco USA

2. Oncology Clinical Pharmacology; Novartis; East Hanover USA

3. Clinical Pharmacology; Genentech; South San Francisco USA

4. Clinical Pharmacology & Pharmacometrics; Bristol-Myers Squibb; Lawrenceville USA

5. The Children's Hospital of Philadelphia; Philadelphia; PA USA

6. University of Tennessee Health Science Center; Memphis USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference59 articles.

1. Therapeutic proteins;Dimitrov;Methods Mol Biol,2012

2. Three years of paediatric regulation in the European Union;Olski;Eur J Clin Pharmacol,2011

3. FDA Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling. 2014. Draft guidance Accessed http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM341394.pdf

4. EMA Official Journal of the European Union. Communication from the Commission: Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies /C 234/01) 2010 http://ec.europa.eu/health/files/eudralex/vol-1/com_2008_jo243/com_2008_243_en.pdf/

5. Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices;Morford;Birth Defects Res B Dev Reprod Toxicol,2011

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