Paediatric drug development: The impact of evolving regulations

Turner, Mark A.; Catapano, Mariana; Hirschfeld, Steven; Giaquinto, Carlo

doi:10.1016/j.addr.2014.02.003

Cited by 131 publications

(101 citation statements)

References 63 publications

Supporting

Mentioning

100

Contrasting

Unclassified

Order By: Relevance

“…ten subjects). The importance of creating paediatric-and geriatricfriendly dosage forms that are palatable, dose-titratable and efficacious is a current focus for pharmaceutical companies and regulatory entities [23]. Microsphere dosage forms provide distinct advantages over traditional pills, tablets and capsules due to their ability to be mixed with liquids (e.g.…”

Section: Resultsmentioning

confidence: 99%

Pharmacokinetics of a Taste-Masked Prednisone Oral Microsphere Powder

Shoults¹,

Gl²,

Ar³

et al. 2017

J Bioequiv Availab

View full text Add to dashboard Cite

Section: Resultsmentioning

confidence: 99%

Pharmacokinetics of a Taste-Masked Prednisone Oral Microsphere Powder

Shoults¹,

Gl²,

Ar³

et al. 2017

J Bioequiv Availab

View full text Add to dashboard Cite

“…We take it for granted that the regulatory environment is supportive of research in neonates and will develop fruitfully [98]. The next 5 years will see the dissemination and implementation of existing good practice in neonatal pharmacovigilance.…”

Section: Five-year Viewmentioning

confidence: 99%

Adverse drug reactions in neonates: could we be documenting more?

Hawcutt

O’Connor

Turner

2014

Expert Review of Clinical Pharmacology

View full text Add to dashboard Cite

Neonates are vulnerable to adverse drug reactions but reports of these events are relatively infrequent. Reporting can be increased by adapting a number of standard techniques to the unique features of neonatal care and pathology. However, clinicians and parents will be reluctant to report information about harms in the absence of mechanisms to ensure that reports affect clinical practice. Improved reporting will depend on education and cultural change that are informed by research about pharmacovigilance in neonatal settings. The efficient use of neonatal adverse drug reaction reports will require harmonization of terminology and interoperable databases.

show abstract

“…Simultaneously the World Health Organisation (WHO, 2007) spearheaded a 77 global campaign to raise awareness and accelerate action to address the need for improved 78 availability and access to safe, child-specific medicines for all children under 12 years of age. 79 Similar legislation has been enacted in the US (Turner et al, 2014). 80…”

Section: Introduction 60mentioning

confidence: 96%

A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

Richey

Hughes

Craig

et al. 2017

International Journal of Pharmaceutics

View full text Add to dashboard Cite

systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice.International Journal of Pharmaceutics http://dx.doi.org/10. 1016/j.ijpharm.2016.12.032 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. This study sought to determine whether there is an evidence base for drug manipulation to obtain 37 the required dose, a common feature of paediatric clinical practice. A systematic review of the 38 data sources, PubMed, EMBASE, CINAHL, IPA and the Cochrane database of systematic 39 reviews, was used. Studies that considered the dose accuracy of manipulated medicines of any 40 dosage form, evidence of safety or harm, bioavailability, patient experience, tolerability, 41 contamination and comparison of methods of manipulation were included. Case studies and 42 letters were excluded. Fifty studies were eligible for inclusion, 49 of which involved tablets 43 being cut, split, crushed or dispersed. The remaining one study involved the manipulation of 44 suppositories of one drug. No eligible studies concerning manipulation of oral capsules or 45 liquids, rectal enemas, nebuliser solutions, injections or transdermal patches were identified. 46Twenty four of the tablet studies considered dose accuracy using weight and/or drug content. In 47 studies that considered weight using adapted pharmacopoeial specifications, the percentage of 48 halved tablets meeting these specifications ranged from 30% to 100%. Eighteen studies 49 investigated bioavailability, pharmacokinetics or clinical outcomes following manipulations 50 which included nine delayed or modified release formulations. In each of these nine studies the 51 entirety of the dosage form was administered. Only one of the 18 studies was identified where 52 drugs were manipulated to obtain a proportion of the dosage form, and that proportion 53 administered. The five studies that considered patient perception found that having to manipulate 54 the tablets did not have a negative impact on adherence. Of the 49 studies only two studies 55 reported investigating children. This review yielded limited evidence to support manipulation of 56 medicines for children. The results cannot be extrapolated between dosage forms, methods of 57 manipulation or between different brands of the same drug. 58 59 4 INTRODUCTION 60Many medicines given to children are used "off-label" because the medicine has only been 61 researched and authorised for adults. Often the dosage form (e.g., tablets, capsules, 62 suppositories) is suitable for administration to adults but not to younger children (Waller, 2007). 63Age...

show abstract

Paediatric drug development: The impact of evolving regulations

Cited by 131 publications

References 63 publications

Pharmacokinetics of a Taste-Masked Prednisone Oral Microsphere Powder

Pharmacokinetics of a Taste-Masked Prednisone Oral Microsphere Powder

Adverse drug reactions in neonates: could we be documenting more?

A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice

Contact Info

Product

Resources

About