Developing methodologies for the evaluation of age-appropriate formulations (AaFs) in children



Duncan, Jennifer ORCID: 0000-0001-9713-888X
(2019) Developing methodologies for the evaluation of age-appropriate formulations (AaFs) in children. PhD thesis, University of Liverpool.

[thumbnail of 201005306_May 2019.pdf] Text
201005306_May 2019.pdf - Unspecified

Download (7MB) | Preview

Abstract

Children deserve access to medicines that have been tailored to their individual needs and developed in an age-appropriate dosage form (or formulation). Unfortunately, pharmaceutical development has often neglected children in the past so there is a general lack of suitable, commercially available age-appropriate formulations (AaFs). Consequently, clinicians often have no choice but to treat children with available medicines as it would be considered unethical to withhold these treatments. Available options may have originally been ‘intended’ for use in adults or for different indications and so have not been fully evaluated for paediatric use, making their use off-label (OL) as they deviate from the manufacturer’s instructions. OL medicines may be unsuitable for children in terms of their strength, dosage form (DF) and/or excipients. Other medicines which do not have a marketing authorisation (MA) in the United Kingdom and are therefore said to be unlicensed (UL), may need to be sourced or manufactured, in order to fill this gap. An age-inappropriate formulation (AiF) is a medicine which needs to be manipulated at the point of administration (by parents/carers/users) to allow the ‘intended’ dose ... (continues)

Item Type: Thesis (PhD)
Uncontrolled Keywords: Paediatrics, Age-appropriate formulations, medicines
Divisions: Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences > School of Medicine
Depositing User: Symplectic Admin
Date Deposited: 08 Jan 2020 09:26
Last Modified: 01 Jan 2025 02:30
DOI: 10.17638/03061920
Supervisors:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3061920