Demonstrating evidence of acceptability: The "Catch-22" of pediatric formulation development

Clinical Pharmacology and Therapeutics

Volumn 94, Issue 5, 2013, Pages 582-584

  Ranmal, S ^a   Tuleu, C ^a  

^a UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CHILD; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM; DRUG FORMULATION; HUMAN; PEDIATRICS; PRIORITY JOURNAL; REVIEW;

ADMINISTRATION, ORAL; AGE FACTORS; CAPSULES; CHILD; DOSAGE FORMS; DRUG EVALUATION; HUMANS; TABLETS;

EID: 84886716900     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.154     Document Type: Review

References (5)

1. Riet-Nales, D.A. van Schobben, A., Egberts, T.C.G. & Rademaker, C.M.A. Effects of the pharmaceutical technologic aspects of oral pediatric drugs on patientrelated outcomes: A systematic literature review. Clin. Ther. 32, 924-938 (2010).
2. Committee for Medicinal Products for Human Use (CHMP) reflection paper: Formulations of choice for the paediatric population. (2006).
3. European Medicines Agency (EMA) guideline on pharmaceutical development of medicines for paediatric use (Draft) (EMA/CHMP/QWP/180157/2011). (2011).
4. European Medicines Agency (EMA) overview of comments received on "guideline on pharmaceutical development of medicines for paediatric use"(EMA/CHMP/QWP/180157/2011). (2013).
5. European Medicines Agency (EMA) guideline on pharmaceutical development of medicines for paediatric use (Draft) (EMA/CHMP/QWP/805880/2012 Rev. 1). (2013).