Paediatrics

K. Albertsson-Wikland, O. Westphal, and U. SSlestgmn,Acta Paediatr. Scand. 75, 89 (1986). 

Astrid Novosel, Arndt Borkhardt Universitat Dusseldorf, Children s University Hospital, Department of Paediatric Haematology Oncology Clinical Immunology, Dusseldorf, Germany... 

Regulation (EC) No. 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use... 

In the US, a manufacturer may not submit an application that relies on data from an approved submission for a period of 5 years after the reference product was authorised, unless the owner of the original data has granted a right of reference. The FDA may not approve an application that relies on data submitted as a supplement (e.g. new therapeutic indication) to an authorised drug for a period of 3 years after approval ofthe supplement. These exclusivity periods will be extended by 6 months if the reference submissions contain paediatric data. The FDA will also not... 

A paediatric application approved for the new pharmaceutical form 7 years after approval of the original product. 

The generic manufacturer may not submit an ANDA for the new pharmaceutical form until 11.5 years after approval of the original product (i.e. 5 years from the date of approval of the new form + 0.5 years for the paediatric application). 

CFR 601.28 Distribution data Current labelling CMC new information New non-clinical studies New clinical data Status report on post-approval study commitments, e.g. paediatric studies Minor supplementary changes... 

Schwartz J, Levin R, Hodge K (1997) Drinking water turbidity and paediatric hospital use for gastrointestinal illness in Philadelphia. Epidemiology 8 615-620... 

Hughes J, Leach HJ, Choonara I Hallucinations on withdrawal of isoflurane used as sedation. Acta Paediatr 82 885—886, 1993... 

Stewart RD, Fisher TN, Hosko MJ, et al Experimental human exposure to methylene chloride. Arch Environ Health 25 342-348, 1972 Substance Abuse and Mental Health Services Administration Preliminary Estimates from the 1995 National Household Survey on Drug Abuse. Rockville, MD, U.S. Department of Health and Human Services, 1996 Tenenbein M, PillayN Sensory evoked potentials in inhalant (volatile solvent) abuse. J Paediatr Child Health 29 206-208, 1993... 

De Silva IL, Mehr SS, Tey D, Tang ML Paediatric anaphylaxis a 5-year retrospective review. Allergy 2008 63 1071-1076. 

Pearn J. The world s longest surviving paediatric practices Some themes of Aboriginal medical ethnobotany in Australia. J Paediatr Child Health 2005 41 284-90. 

AMERICAN ACADEMY OF PAEDIATRICS (1998) Soy proteiu-based formulas recommendations for use in infant feeding (RE9806). Paediatrics. 101 148-53. 

Burdelski, M., Oellericch, M., Pippenger, C.E., Meng, X., Rodeck, B., Latta, A. and Kucher, K. (1990). Free radical scavenging enzyme activities in erythrocytes of paediatric patients with Crohn s disease. In Trends in Inflammatory Bowel Disease Therapy (ed. C. J. Williams), pp. 453-454. Kluwer Academic Publishers, Lancaster. 

Kawai, M., Sumimoto, S., Kasajima, Y. and Hamamoto, T. (1992). A case of ulcerative colitis induced by oral ferrous sulphate. Acta Paediatr. Jpn. 34, 476-478. 

Lemonnier, P., Cresteil, D., Feneant, M., Couturier, M., Bernard, O. and AlagjUe, D. (1987). Plasma lipid peroxides in cholestatic children. Acta Paediatr. Scand. 76, 928-934. 

Pitt, R.M., McKelvey, T.G., Saenger, J.S., Shah, A.K., Jones, H.P., Manci, E.A. and Powell, R.W. (1991). A tungsten-supplemented diet delivered by transplacental and breastfeeding routes lowers intestinal xanthine oxidase activity and affords cytoprotection in ischaemia-reperfusion injury to the small intestine. J. Paediatr. Suig. 26, 930-935. 

Ward, K.P., Arthur, J.R., Russell, G. and Aggett, P.J. (1984). Blood selenium content and glutathione peroxidase activity in children with cystic fibrosis, coeliac disease, asthma and epilepsy. Eur. J. Paediatr. 142, 21-24. 

Stinson J, Naser B. Pain management in children with sickle cell disease. Paediatr Drugs 2003 5 229-238. 

B. Anderson, A. McKee, and N. Holford, Size, myths and clinical pharmacokinetics of analgesia in paediatric patients, Clin. Pharmacokinetics, 33(5), 313 (1997). 

La Scolea, L. Diagnosis of paediatric infections using bacterial antigen detection systems. Clin. Microbiol. Newsletter 1998,10,21-23. 

A1 Khayat A, Menon NS, Alidina MR. 1997a. Acute lead encephalopathy in early infancy-clinical presentation and outcome. Annals of Tropical Paediatrics 17(l) 39-44. 

Grant LD, Davis JM. 1987. Effect of low-level lead exposure on paediatric neurobehavioral and physical development Current findings and future directions. In Smith M, Grant LD, Sors A, eds. Lead exposure and child development An international assessment. Lancaster, UK Kluwer Academic Publishers. 

Larsson B, Slorach SA, Hagman U, et al. 1981. WHO collaborative breast feeding study. Acta Paediatr Scand 70 281-284. 

Lyngbye T, Hansen ON, Trillingsgaard A, et al. 1990a. Learning disabilities in children Significance of low-level lead-exposure and confounding factors. Acta Paediatr Scan 79 352-360. 

D. O. Thompson, and J. P. Mannermaa. Intestinal safety of water-soluble beta-cyclodextrins in paediatric oral solutions of spironolactone effects on human intestinal epithelial Caco-2 cells,... 

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