Workshop 7: Special pediatric problems
The assessment of NBAAD in pediatric patients is essential because asthma is common in children. Special problems of drug assessment in children should be considered in the context of various pediatric growth periods: (1) adolescence; (2) childhood (2 years to onset of adolescence); (3) infants/toddler (1 month to 2 years); and (4) neonatal (birth to 1 month). Rapid acceleration of growth and maturation are special problems in adolescence. In addition, awareness about safety, possible drug abuse, and compliance must be considered in this age group. Drug studies should also take into account the fact that natural remissions may occur more frequently in teenagers, especially in boys. In the childhood age group, asthma is more likely to be induced by respiratory viral infections; various endocrine parameters need to be followed more closely; and special attention should be paid to the detection of variations in growth and bone age. Dose ranging effects should be established in the very early stages of drug development and the kinetics of drug action should be followed in cases in which proper assays are available. Except in very young children, parameters for measuring drug effectiveness are the same as in adults. Special instructions should be devised for aerosolized medications if the drug is available only in this form. Ethical constraints in children are key problems. Double-blind testing with a placebo control is not advisable in the younger groups of children. Instead, drugs should be tested against other agents of known efficacy. Research in infants should be deferred until substantial evidence of safety and effectiveness has been gathered in older children or adults. The commercial marketing of drugs of potential use to children should be deferred until studies in older children and adolescents have been included in the FDA review process. © 1986.
Siegel, SC; Sogn, DD; Bierman, CW; Buckley, RH; Ellis, EF; Fischer, TJ; Levinson, H; Sly, RM; Westlin, WF
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