2014
DOI: 10.1016/j.ijpharm.2014.03.057
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Regulatory perspectives on acceptability testing of dosage forms in children

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Cited by 102 publications
(97 citation statements)
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“…Child-centred research: from subjects to participants to contributors Despite the proposed paradigm shift towards child-centred research, there is much less empirical and methodological knowledge to guide this with younger populations compared to adults. Regulators 410 suggest that acceptability of medicinal products should be preferably assessed with children themselves (EMA, 2013, Kozarewicz, 2014. This is advocated given sensory and perceptual differences across ages, and increasing evidence highlighting that attitudes and experiences are most accurately and reliably obtained from children themselves.…”
Section: Practicesmentioning
confidence: 99%
See 1 more Smart Citation
“…Child-centred research: from subjects to participants to contributors Despite the proposed paradigm shift towards child-centred research, there is much less empirical and methodological knowledge to guide this with younger populations compared to adults. Regulators 410 suggest that acceptability of medicinal products should be preferably assessed with children themselves (EMA, 2013, Kozarewicz, 2014. This is advocated given sensory and perceptual differences across ages, and increasing evidence highlighting that attitudes and experiences are most accurately and reliably obtained from children themselves.…”
Section: Practicesmentioning
confidence: 99%
“…A strong emphasis is placed on ensuring that formulations are acceptable to patients, by demonstrating "the overall ability and willingness of the patient to use and its caregiver to administer the medicine as intended" (EMA, 2013, Kozarewicz, 2014. Indeed, designing formulations that are both suitable and favourable for end-users can benefit patient adherence and ultimately therapeutic outcomes; thus, it is just to insist that this is evaluated during 20 pharmaceutical and clinical development.…”
Section: Introductionmentioning
confidence: 99%
“…Medication adherence rates 20 between 11% and 93% in paediatric patients have been reported (Winnick et al, 2005). 21 Acceptability has previously been defined as the overall ability of a patient/ caregiver to use a 22 medicinal product as intended / authorised (Kozarewicz, 2014). Acceptability of a medicinal product 23 has potential to significantly affect the patient's adherence and therefore is likely to influence safety 24 and efficacy of a product (Kozarewicz, 2014).…”
mentioning
confidence: 99%
“…21 Acceptability has previously been defined as the overall ability of a patient/ caregiver to use a 22 medicinal product as intended / authorised (Kozarewicz, 2014). Acceptability of a medicinal product 23 has potential to significantly affect the patient's adherence and therefore is likely to influence safety 24 and efficacy of a product (Kozarewicz, 2014). Usability has been used interchangeably with 'human 25 factors' and defined as a 'multi-dimensional quality', which reflects human ability 'to interact easilyand relatively error-free with a system or product.'…”
mentioning
confidence: 99%
“…by review of literature references or by studies in trained adult panels (33). No guidance is given on the test method and acceptance criteria, implying that any properly justified proposal may be accepted (81). The guideline does not explicitly address in vitro measurements for taste assessments such as the electronic or e-tongue.…”
Section: Paediatric Drug Product Design: Patient Acceptabilitymentioning
confidence: 99%