Pediatric groups

C) PEDIATRIC FORMULATION NOT POSSIBLE. If a waiver is granted on the ground that it is not possible to develop a pediatric formulation, the waiver shall cover only the pediatric groups requiring that formulation. 

American Academy of Pediatrics. Group A streptococcal infections. In Pickering LK, ed. Red Book 2003 Report of the Conunittee on Infectious Diseases, 26th ed. Elk Grove Village, IL, American Academy of Pediatrics 2003 526-536. 

Not long afterward, a few miles north of Ground Zero — the empty ground where the World Trade Center once stood—a pediatrics group at the Mt. Sinai School of Medicine, together with others there and at the Bronx Veterans Affairs Medical Center, began to ask a simple question Was it possible the shock of the 9/11 catastrophe had caused effects in the fetuses of pregnant women who lived close to the disaster ... 

The incidence of PSC in adult IBD patients treated with corticosteroids (50%) is much higher than those in pediatric patients (21 %). This may be attributable to the fact that adult IBD patients, on average, were treated with 3 times the total amount of prednisone and for twice as long as the pediatric group. The predominantly nonlabile nature of PSC may be an additional explanation for this observation. The lower incidence of raised lOP in the adults as compared to the pediatric patient population (8% vs. 36% respectively) is most probably related to discontinuation of prednisone in the adults for months prior to our ocular examination. 

Glezen WP, Loda FA, Clyde WA Jr, et al. Epidemiologic patterns of acute lower respiratory diseases in pediatric group practice. J Pediatr 1971 78 397-406. 

Vaccines are used in either the general population of children or adults or for special groups. Recommendations for vaccine usage are made by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control. The Committee on Infectious Diseases of the American Academy of Pediatrics (Redbook Committee) also makes recommendations for infants through adolescents, and the American Academy of Family Physicians makes recommendations for adults. An excellent review of vaccine history, development, usage, and related regulatory issues is available (2). 

Casey JR, Pichichero ME. Meta-analysis of cephalosporin versus penicillin treatment of group A streptococcal tonsillopharyngi-tis in children. Pediatrics 2004 113(4) 866-882. 

Dowell SF, Butler JC, Giebink GS, et al. Acute otitis media Management and surveillance in an era of pneumococcal resistance—A report from the Drug-resistant Streptococcus pneumoniae Therapeutic Working Group. Pediatr Infect Dis J 1999 18(l) l-9. 

Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the use of antiretroviral agents in pediatric HIV infection. October 26, 2006. (http //aidsinfo.nih.gov)... 

In the pediatric age group, most pneumonias are due to viruses, especially respiratory syncytial virus, parainfluenza, and adenovirus. Pneumococcus is the most common bacterial cause, followed by Group A Streptococcus and S. aureus. 

Guidelines from the Infectious Disease Society of America, American Academy of Pediatrics, and the American Heart Association suggest that testing for Group A Streptococcus be done in all patients with signs and symptoms. Only those with a positive test for Group A Streptococcus require antibiotic treatment. 

A glucocorticoid-resistance model has been proposed to provide an explanation for how stress might influence diseases in which excessive inflammation is observed (e.g., allergies, autoimmune diseases, rheumatoid arthritis, and cardiovascular disease). In these cases, chronic stress diminishes the immune system s sensitivity to glucocorticoids that normally terminate the inflammatory response. For example, in a study of a group of 50 parents caring for a child undergoing treatment for pediatric cancer, whole blood of parents of cancer patients exhibited a lesser dexamethasone-dependent suppression of IL-6 production in vitro compared to parents of medically healthy children.94... 

The database for HFC-134a is extensive it contains studies with both human subjects and animal models. Potentially sensitive populations, including patients with COPD and adult and pediatric asthmatic patients, were tested with direct inhalation of HFC-134a from metered-dose inhalers. The response of these groups was no different than that of healthy adults. The animal studies covered acute, subchronic, and chronic exposure durations and addressed systemic toxicity as well as neurotoxicity, reproductive and developmental effects, cardiac sensitization, genotoxicity, and carcinogenicity. The metabolism of HFC-134a is well understood, and the relationship of exposure con... 

Acknowledgments The authors thank the members of the Kentucky Pediatric Research Institute working group for valuable advice and assistance. This work was supported, in part, by the National Heart, Lung, and Blood Institute (HL68509 and HL78976 EJS). 

Choice of Control Group and Related Issues in Clinical Trials Clinical Investigation of Medicinal Products in the Pediatric Population... 

Owen, M.J., et al. (1993). Relation of infant feeding practices cigarette smoke exposure and group children care to the onset and duration of otitis media with effusion in the first years of life, J. Pediatric., 123, 702-710. 

Children Not recommended for patients younger than 12 years of age. Safety and efficacy are not established for amoxapine in children younger than 16 years of age or trazodone or clomipramine in children younger than 10 years of age. The safety and efficacy of imipramine as temporary adjunctive therapy for nocturnal enuresis in pediatric patients younger than 6 years of age have not been established. The safety of the drug for long-term, chronic use as adjunctive therapy for nocturnal enuresis in pediatric patients 6 years of age and older has not been established. Safety and efficacy are not established in the pediatric age group for trimipramine, nortriptyline, protriptyline, and desipramine. 

Pediatric patients weighing 40 kg or more - Experience with Augmentin ES-600 in this group is not available. 

This pediatric cancer stands as an example of how cooperative group studies (NWTS and SIOP) have been able to integrate both chemotherapy and radiation into standard therapy while minimizing side-effects and dramatically improving cure rates as seen in the improvement of the 5-yr relative survival rates from 74% in 1974-1976 to 93% in 1989-1996 (60). The fifth NWTS trial began in 1995 and is expected to continue until 2003 (see Table 5) (60). This study will search for biological prognostic factors and examine the rates of cancer and birth defects in children born to survivors of Wilms tumor. 

Laver JH, Barredo JC, AmylonM, etal. Effects of cranial radiation in children with high risk T cell acute lymphoblastic leukemia a Pediatric Oncology Group report. Leukemia 2000 14(3) 369-373. 

American Academy of Pediatrics. Work Group on Breastfeeding (1997). Breastfeeding and the use of human milk. Pediatrics 100,1035-1039. 

Goorin AM, Schwartzentruber DJ, Devidas M, Geb-hardt MC, Ayala AG, Harris MB et al. Presurgical chemotherapy compared with immediate surgery and adjuvant chemotherapy for non-metastatic osteosarcoma Pediatric Oncology Group Study POG-8651. J Clin Oncol 2003 21 1574-80. 

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