Protection of children from medication toxicity and providing evidence of effectiveness have long been the goals of studies of drugs in infants, children and adolescents. Ideally, the first child studied with a newly approved medication will receive that drug in dosages based on well-controlled studies with well-studied appropriate formulations in similar aged patients with similar disorders that established efficacy similar to what was required in adults. With motivation to achieve what is best for children, we have come a long way, but the progress is incomplete.
In the 1800's, the beginning of modern pharmacopeia's emerged in the U.S. and Europe.1 These specified how to create medications by pharmacists who were skilled chemists. In the U.S., the first pharmacopoeia was published in 1820 and this was supplemented by legally protected Patent Medicines that often made outrageous therapeutic claims. A single product, such as Dr. Roger's Syrup, might be labeled effective...
