Evidence of harm from off-label or unlicensed medicines in children [En ligne] Disponible sur: http://www.ema.europa.eu/docs/en_GB/document_library/Other De Jong-van den Berg, « Lack of appropriate formulations of medicines for children in the community [6] United Nations, « Convention on the Rights of the Child », UNICEF, nov Droit civil: Introduction au droit, personnes, famille, personnes protégées, biens, obligations, sûretés La naissance de l'intelligence de l'enfant, 9ème édition « Clinical investigation of medicinal products in the pediatric population Sonies, et C. Macedonia, « Emergence of oropharyngeal, laryngeal and swallowing activity in the developing fetal upper aerodigestive tract: an ultrasound evaluation Debotton et A. Dahan, « A mechanistic approach to understanding oral drug absorption in pediatrics: an overview of fundamentals Comparison of serum levels following the administration of oral and parenteral preparations of penicillin to infants and children of various age groups, Disponible sur 1238?1244, déc. 1962. [4] European Medicines AgencyWC500004021.pdf. [Consulté le: 08-févr-2015]. [5] Introduction. Neuchâtel: Delachaux et Niestlé, 1977. [9] International Conference on Harmonisation Pediatric Development: Physiology. Enzymes, Drug Metabolism, Pharmacokinetics and Pharmacodynamics Pediatric formulations: a roadmap, D. Bar- Shalom and K. Rose. EMC -Gastro-Entérologie, pp.1-2015, 1938. ,
Single dose pharmacokinetics of pleconaril in neonates, Pediatr. Infect. Dis. J, vol.1916, issue.9, 2000. ,
An overview on: Sublingual route for systemic drug delivery » Oral transmucosal drug delivery for pediatric use Tuleu, « Rectal route in the 21st Century to treat children », Adv « Intravenous drug delivery in neonates: lessons learnt « A literature review on flow-rate variability in neonatal IV therapy, Development of Functional Response in Human Exocrine Pancreas Intramuscular Injections in Children 944?948, déc Vaccine Administration Guidelines. » US Department of Health and Human Serves, 2014. [24] W. A. Engle, « Intraosseous Access for Administration of Medications in Neonates 161?168, mars 2006. [25] L. D. Mastrandrea et T. Quattrin, « Clinical evaluation of inhaled insulin 9?10, p. 1061?1075, oct. 2006. [26] J. M. Couriel et F. Child, « Applied physiology: lung function testing in children », Curr. Paediatr. Topical and Transdermal Pediatric formulation: a roadmap, pp.913-923, 1980. ,
Falcão, « Intranasal delivery of systemic-acting drugs: Small-molecules and biomacromolecules », Eur « Direct measurement of ear canal volume in a pediatric population: Can we explain its individual variation in terms of age and body weight?, 51?57, mars 1996. [32] H. Noh et D.-H. Lee, pp.658-662, 2003. ,
Ocular and systemic side effects of brimonidine 0.2% eye drops (Alphagan??) in children, Tear Film Volume and Protein Analysis in Full-term Newborn Infants », Cornea 400?404, avr. 2011. [35] J.-P. Labaune, Pharmacocinétique!: principes fondamentaux, pp.24-26, 1984. ,
DOI : 10.1067/mpa.2001.117571
Thakker, « A Physiologically Based Pharmacokinetic Model for Voriconazole Disposition Predicts Intestinal First-pass Metabolism in Children Klingenberg, « High-dose gentamicin in newborn infants: is it safe? Sebire, « Reference ranges for organ weights of infants at autopsy: results of >1,000 consecutive cases from a single centre, 1171?1182, déc 320S?329S, mai 2014. [39] Barrier Mechanisms in the Developing Brain févr. 2012. [43] B. Engelhardt et S. Liebner, « Novel insights into the development and maintenance of the blood?brain barrier 687?699, janv. 2014. [44] L. Notarianni, « Plasma Protein Binding of Drugs in Pregnancy and in Neonates, pp.93-113, 1990. ,
Canning, « Drug metabolism in the paediatric population and in the elderly « Differences in absorption, distribution, metabolism and excretion of xenobiotics between the paediatric and adult populations, Developmental Pharmacology ? Drug Disposition, Action, and Therapy in Infants and Children 447?471, sept. 2005. [48] G. D. Anderson, « Developmental Pharmacokinetics, pp.208-213, 2003. ,
Once-Daily Formulation of Tacrolimus in Stable Renal Transplant Recipients « Developmental variations in metabolic capacity of flavin-containing mono-oxygenase 3 in childhood », Br « The Aldo-Keto Reductase Superfamily and its Role in Drug Metabolism and Detoxification, Influence of Cytochrome P450 3A5 (CYP3A5) Genetic Polymorphism on the Pharmacokinetics of the Prolonged-Release 585?591, nov Pharmacokinetics of imipenem-cilastatin in neonates. » Questions and answers on Tienam and associated names (imipenem/cilastatin for infusion 500 mg/500 mg), pp.431-435, 1985. ,
Pons, « Isoniazid acetylation metabolic ratio during maturation in children, Caffeine Acetylator Phenotyping during Maturation in Infants, pp.492-495, 1991. ,
Drug methylation in cancer therapy: lessons from the TPMT polymorphism, Acetylation Polymorphism: Prevalence of Slow Acetylators Does Not Differ between Atopic Dermatitis Patients and Healthy Subjects Differences Between Children and Adults in Thiopurine Methyltransferase Activity and Metabolite Formation During Thiopurine Therapy: Possible Role of Concomitant Methotrexate Glucuronidation in Humans », pp.386-392, 1999. ,
DOI : 10.7326/0003-4819-126-8-199704150-00003
Chloramphenicol toxicity in neonates: its incidence and prevention., 1424?1427, nov, 1983. ,
DOI : 10.1136/bmj.287.6403.1424
« Developmental Expression of Aryl, Estrogen, and Hydroxysteroid Sulfotransferases in Pre-and Postnatal Human Liver, Vest et R. Rossier, « Detoxification in the newborn: the ability of the newborn infant to form conjugates with glucuronic acid, glycine, actetate and glutathione », pp.1310-1317, 2006. ,
Pharmacokinetic considerations in the adolescent: Noncytochrome P450 metabolic pathways « The ontogeny of human drug-metabolizing enzymes: phase II conjugation enzymes and regulatory mechanisms, « L'estimation du débit de filtration glomérulaire en 2012 : quelle valeur ajoutée pour la nouvelle équation CKD-EPI ? », Néphrologie Thérapeutique Ontogeny of drug elimination by the human kidney How to Estimate the Dose to Be Given for the First Time to Pediatric Patients Pediatric Formulations. [71] Organisation Mondiale de la Santé, « OMS | Poids-pour-l'âge, pp.183-198, 1963. ,
Consulté le: 01- févr-2015]. [72] U.S. Food and Drug Administration, « Pediatric Science and Research Activities », 2015. [En ligne]. Disponible sur: http://www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch, History of the Paediatric initiatives, 2007. ,
« Les essais cliniques pédiatriques': de la théorie à la réalité du terrain, 2012. ,
Consulté le: 15-févr-2015]. [79] ANSM, « Résumé du Rapport Périodique de Synthèse N°2 Orphan Europe Autorisation Temporaire d'Utilisation de Cohorte (ATUc) Cystadrops® 0.55% Collyre en solution the survey of all paediatric uses of medicinal products in Europe, L'usage compassionnel en Europe et en France. Illustration': le crizotinib en ATU Disponible sur, 2010. ,
Food and Drug Administration, « Federal Food and Drugs Act of 1906 -The Wiley Act », Legislation _ Federal Food and Drugs Act of 1906 Disponible sur: http://www.fda.gov/RegulatoryInformation/Legislation/ucm148690.htm. [Consulté le: 12- avr-2015]. [84] Congrès des Etats-Unis d'Amérique, « Food and Drug Administration Modernization Act of 1997. » City of Washington, 1997. [85] Congrès des Etats-Unis d'Amérique, « Best Pharmaceuticals for Children Act [En ligne] Disponible sur: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDC Act/SignificantAmendmentstotheFDCAct/ucm148011.htm. [Consulté le: 12-avr-2015]. [86] Congrès des Etats-Unis d'Amérique, « Pediatric Research Equity Act of, Off-Label Prescribing in Pediatric Outpatients Are the Kids Alright? | The Scientist Magazine® », 2012. [89] Conseil de la Communauté Européenne, « Directive 65 Disponible sur, pp.26-196531965, 1906. ,
Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies. » 2014. [94] European Medicines Agency, « Decision Class Waiver on conditions -granting, review, revocation. » 2011. [95] European Medicines Agency, « SOP3207 -Handling of applications for paediatric investigation plan and or waiver from presubmission to PDCO [96] European Medicines Agency, « Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric rewards, 98] European Medicines Agency, « Application guidance -Standard paediatric investigation plans Disponible sur99] European Medicines Agency, « Questions and answers on the paediatric use marketing authorisation, 2009. ,
Better Medicines for Children: From concept to reality, Progress report on the paediatric regulation (EC) N°1901, 2006. ,
The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children, Orphanet Journal of Rare Diseases, vol.92, issue.L18, pp.120-120, 2014. ,
DOI : 10.1002/bdrb.20328
« Presse realease of a second positive opinion for a PUMA, 2014. ,
More than 5 years of European Paediatric Regulation: Statistics and industrial experience, Initiat. EuPFI 5th Annu. Conf. 2013, pp.260-262, 2014. ,
DOI : 10.1016/j.ijpharm.2014.03.058
« Draft guideline on pharmaceutical development of medicines for paediatric use, 2011. ,
Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study, Archives of Disease in Childhood, vol.97, issue.3, pp.283-286, 2012. ,
DOI : 10.1136/archdischild-2011-300958
Determination of formulation factors that affect oral medicines acceptability in a domiciliary paediatric population », Int, J. Pharm, vol.480, issue.1?2, pp.55-62, 2015. ,
« Patient-Centred Pharmaceutical Design to Improve Acceptability of Medicines: Similarities and Differences in Paediatric and Geriatric Populations, Drugs, vol.74, issue.16, pp.1871-1889, 2014. ,
Pediatric Drugs-A Review of Commercially Available Oral Formulations, Journal of Pharmaceutical Sciences, vol.97, issue.5, pp.1731-1774, 2008. ,
DOI : 10.1002/jps.21101
Research in Paediatrics (GRiP) -paediatric clinical pharmacology studies. » [En ligne] Disponible sur: http://www.grip-network.org/index, Consulté le, pp.5-2015 ,
« An Evaluation of the Poison Prevention Packaging Act, Pediatrics, vol.69, issue.3, pp.363-370, 1982. ,
The Safety Effects of Child-Resistant Packaging for Oral Prescription Drugs, JAMA, vol.275, issue.21, pp.1661-1665, 1996. ,
DOI : 10.1001/jama.1996.03530450051032
Unit of Measurement Used and Parent Medication Dosing Errors, PEDIATRICS, vol.134, issue.2, pp.354-361, 2014. ,
DOI : 10.1542/peds.2014-0395
administration des solutions buvables': attention aux erreurs -Point d'Information », 2013. [En ligne] Disponible sur: http://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/Pipettes-et-autres- dispositifs-d-administration-des-solutions-buvables-attention-aux-erreurs-Point-d-Information, pp.5-2015 ,
The Bad Taste of Medicines: Overview of Basic Research on Bitter Taste, The Bad Taste of Medicines: Overview of Basic Research on Bitter Taste, pp.1225-1246, 2013. ,
DOI : 10.1016/j.clinthera.2013.06.007
Formulation approaches in enhancement of patient compliance to oral drug therapy, Expert Opinion on Drug Delivery, vol.115, issue.4, pp.1521-1529, 2011. ,
DOI : 10.1016/S0168-3659(99)00222-9
Study of the acceptability of antibiotic syrups, suspensions, and oral solutions prescribed to pediatric outpatients, European Journal of Pediatrics, vol.115, issue.Suppl 1, pp.851-857, 2009. ,
DOI : 10.3928/0090-4481-19961101-06
Le go??t??: physiologie, r??les et dysfonctionnements, Nutrition Clinique et M??tabolisme, vol.27, issue.3, pp.123-133, 2013. ,
DOI : 10.1016/j.nupar.2013.06.002
Histologie : organes, systèmes et appareils. » [En ligne] Disponible sur, pp.6-2015 ,
Orosensory Perception, Pediatric formulations: a roadmap, pp.117-118, 2014. ,
DOI : 10.1007/978-1-4899-8011-3_8
The sweetness and bitterness of childhood: Insights from basic research on taste preferences, Physiology & Behavior, vol.152 ,
DOI : 10.1016/j.physbeh.2015.05.015
« Taste-masking assessment of solid oral dosage forms?A critical review », Int, J. Pharm ,
« In-vitro and in-vivo evaluation of taste-masked cetirizine hydrochloride formulated in oral lyophilisates », Int, J. Pharm, vol.491, issue.1?2, pp.8-16, 2015. ,
Palatability of Oral Antibiotics Among Children in an Urban Primary Care Center, Archives of Pediatrics & Adolescent Medicine, vol.154, issue.3, pp.267-270, 2000. ,
DOI : 10.1001/archpedi.154.3.267
Development of a model for robust and exploratory analysis of the rodent brief-access taste aversion data, European Journal of Pharmaceutics and Biopharmaceutics, vol.91, pp.47-51 ,
DOI : 10.1016/j.ejpb.2015.01.016
Assessing taste without using humans: Rat brief access aversion model and electronic tongue, Better Med. Child. ? Eur. Paediatr. Formul. Initiat. EuPFI 3rd Annu. Conf, pp.137-139, 2012. ,
DOI : 10.1016/j.ijpharm.2012.05.056
« Electronic tongue: An analytical gustatory tool, J ,
A comparative study on two electronic tongues for pharmaceutical formulation development, Journal of Pharmaceutical and Biomedical Analysis, vol.55, issue.2, pp.272-281, 2011. ,
DOI : 10.1016/j.jpba.2011.02.002
Performance qualification of an electronic tongue based on ICH guideline Q2, Journal of Pharmaceutical and Biomedical Analysis, vol.51, issue.3, pp.497-506, 2010. ,
DOI : 10.1016/j.jpba.2009.09.029
Taste sensing systems (electronic tongues) for pharmaceutical applications, International Journal of Pharmaceutics, vol.417, issue.1-2, pp.256-271, 2011. ,
DOI : 10.1016/j.ijpharm.2010.11.028
Tuleu, « Playing hide and seek with poorly tasting paediatric medicines: Do not forget the excipients, Drug Deliv. Paediatr. Popul. Are We At, vol.73, pp.14-33, 2014. ,