Pediatrics clinical studies

Then using actual data from a pediatric clinical study with netilimicin, the authors found that a 2-com-partment model best described the data with no significant covariates affecting central volume. When all the samples prior to 5 h were removed from the data set, a 1-compartment model best described the data. Now, weight and gestational age were important covariates on central volume. Hence, there appeared to be an interaction between identification of important covariates and the structural model. Under all conditions examined, the 2-compartment model consistently identified fewer important covariates than the 1-compartment model. 

In a multi-center, two-year clinical study, inhaled domase-oc was shown to significantly improve lung function and reduce the risk of respiratory exacerbations in pediatric cystic fibrosis patients [25]. 

Another issue facing clinical studies is the inclusion of children. The FDA Modernization Act of 1997 addresses the desirability of pediatric research before new drug approval when a drug is likely to be prescribed for children. The reward for such research is a 6-month prolongation of market exclusivity or patent life. 

Vitiello B, Davies M, Arnold LE, McDougle CJ, Aman M, McCracken JT, Scahill L, Tierney E, Posey DJ, Swiezy NB, Koenig K. Assessment of the integrity of study blindness in a pediatric clinical trial of risperidone. J Clin Psychopharmacol 2005 25 565-9. 

Penny has been involved with a wide range of clinical studies in children with liver disease. These include several that relate to pharmacokinetics, in both liver disease and after liver transplantation. She has presented her research work and given lectures and workshops at national and international congresses, including the International Pediatric Transplant Association, the European Society of Clinical Pharmacy and the Neonatal and Paediatric Pharmacists Group (NPPG) conferences. 

Fuji R, Yoshioka H, Fujita K, Maruyama S, Sakata H, Inyaku F, Chiba S, Tsutsumi H, Wagatsuma Y, Fukushima N, et al. [Pharmacokinetic and clinical studies with meropenem in the pediatric field. Pediatric Study Group of Meropenem.] Jpn J Antibiot 1992 45(6) 697-717. 

Sainmont C, Duprat P, Bourdain M, Loria Y. Etudeclinique du ketotifene solution buvable chez I enfant. Resultats preliminaires sur 257 observations. [Clinical study of an oral solution of ketotifen in children. Preliminary results of 257 cases.] Ann Pediatr (Paris) 1984 31(l) 81-4. 

Peltola H, Safary A, Kayhty H, Karanko V, Andre FE. Evaluation of two tetravalent (ACYW135) meningococcal vaccines in infants and small children a clinical study comparing immunogenicity of O-acetyl-negative and O-acetyl-positive group C polysaccharides. Pediatrics 1985 76(l) 91-6. 

Sunakawa K, Nonoyama M, Fuji R, Iwai N, Sakata H, Shirai M, Sato T, Kajino M, Toyonaga Y, Sano T, Naito A, Minagawa K, Niida Y, Oda T, Yokozawa M, Asanuma H, Shimura K, Fujimura M, Kitajima H, Fujinami K, Numazaki K, Fujikawa T, Kobayashi Y, Sato Y, Nishimura T, Iwata S, Tsuchihashi N, Oishi T, Matsumoto S, Motohiro T, Osawa M, Sunahara M, Shirakawa S, Nishida H, Takahashi N, Nakano R, Sai N, lyoda K, Yoshimitsu K, Ogawa K, Okazaki T, Tsukimoto I, Motoyama O, Takada Y, Kawasaki M, Sunaoshi W, Nakamura S, Ueda Y, Kamata M, Kato T, Chiba M, Ouchi K, Sato S, Horiuchi T, Suzuki K, Shimoyama T, Masaki H, Aikyo M, Kawada M, Banba M, Furukawa S, Okada T, Yamaguchi S, Hirota O, Koizumi S, Wada H, Ohta K, Uehara T, Yukitake K, Mori T, Takakuwa S, Matsuyama K. [Pharmacokinetic and clinical studies on teicoplanin for sepsis by methicillin-cephem resistant Staphylococcus aureus in the pediatric and neonate field.] Jpn J Antibiot 2002 55(5) 656-77. 

This chapter will focus on the current regulatory requirements, their background, the clinical study, challenges and the clinical issues of drug research in the pediatric population. 

The impact of creatinine clearance (CLCr) as a predictor variable for pediatric PM parameters is often low even for renally eliminated drugs due to the inclusion of size (height) in the calculation of renal function and its normalization to adult size. Although the original pediatric renal studies by Schwartz (6) show excellent correlation between measured and estimated CLCr from serum creatinine, others have noted these equations as not predictive in some pediatric subpopulations. The poor precision for the clinical assay of serum creatinine partially accounts for this lack of predictability. However, many pediatric PM analyses have demonstrated the reciprocal of serum creatinine is a powerful covariate for predicting the clearance of renally eliminated drugs, even in infants. 

In addition to antibiotics, dexamethasone has become a commonly used therapy for the treatment of pediatric meningitis. Corticosteroids inhibit the production of both TNF and IL-1. A series of clinical studies assessing the efficacy of corticosteroid therapy for the initial treatment of bacterial meningitis has reported conflicting results. " The majority of trials were conducted on small sample populations, each with different pathogenic bacterial causes and treatment modalities. The findings of several studies have shown significant... 

The efficacy of tacrolimus as a primary immunosuppressant for the prophylaxis of rejection and for rescue therapy following failure of conventional cyclosporin-based rejection prophylaxis has been demonstrated in numerous clinical studies in adults and pediatrics using various types of combination therapy since 1989. Tacrolimus is now well established not only as a primary immunosuppressant in organ transplantation but also an excellent rescue agent for patients experiencing posttransplant rejection while on cyclosporin-based regimens [44]. 

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