Regulatory perspectives on acceptability testing of dosage forms in children

International Journal of Pharmaceutics

Volumn 469, Issue 2, 2014, Pages 245-248

  Kozarewicz, Piotr ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Acceptability; Age appropriateness; Child; Development; Dosage forms; Palatability

Indexed keywords

ARTICLE; CAREGIVER; DRUG DOSAGE FORM; DRUG USE; HUMAN; PALATABILITY; PRIORITY JOURNAL; QUESTIONNAIRE; CHILD; DRUG INDUSTRY; GOVERNMENT REGULATION; LEGISLATION AND JURISPRUDENCE; TASTE;

DRUG; DRUG DOSAGE FORM;

CHILD; DOSAGE FORMS; DRUG INDUSTRY; GOVERNMENT REGULATION; HUMANS; PHARMACEUTICAL PREPARATIONS; TASTE PERCEPTION;

EID: 84902244885     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2014.03.057     Document Type: Article

References (5)

1. Guideline on pharmaceutical development of medicines for paediatric use (Doc. Ref.: EMA/CHMP/QWP/805880/2012 Rev. 2), 2014. Available: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2013/ 01/WC500137023.pdf (accessed 03.14).
2. S. Ranmal, and C. Tuleu Demonstrating evidence of acceptability - the "catch-22" of paediatric formulation development Clinical Pharmacology & Therapeutics 2013 10.1038/clpt.2013.154 accepted article preview online 26 July 2013
3. A. Cram, J. Breitkreutz, S. Desset-Brèthes, T. Nunn, and C. Tuleu Challenges of developing palatable oral paediatric formulations International Journal of Pharmaceutics 365 2009 1 3
4. E. Davis, and C. Tuleu Medicines for children: a matter of taste The Journal of Pediatrics 153 2008 599 604
5. D. Matsui Assessing the palatability of medications in children Paediatric and Perinatal Drug Therapy 8 2007