New medical entity

Administration (FDA) guidelines in the same year (4). In 2001/ the General Accounting Office (GAO) report stated that while the number of women in clinical trials improved/ the FDA needs to do better in terms of effectively overseeing that studies actually compile and present data according to sex (6). For instance/ out of 300 new drug applications submitted to the FDA between the years of 1995 and 2000/ only 163 had sex analysis as part of the submission. Sex-based pharmacodynamic assessment was done for just 39 of 122 new medical entities (7). 

The rapid physical maturation that occurs between birth and adulthood is well known. Logically, it would be anticipated that these changes would result in altered responses to xenobiotics. Within the first 5 years of life 95% of children have been prescribed medications. Yet in 1977 only one third of the new molecular entities that have potential usefulness in pediatric patients had pediatric labeling at the time of approval. 

Straterra is the first new chemical entity approved to treat ADHD in over 30 years, and it has major advantages over the stimulant medications in that it has been clinically demonstrated to have no abuse liability. The nonstimulant mechanism of action also appears to come with some caveats in terms of efficacy versus the stimulants. Synthetically, the main challenge within this molecule is installing the chiral center, which is... 

The methodology to predict the time course of drug concentration in plasma after administration is well described and well accepted as a pharmacokinetic principle. Today, pharmacokinetic principles are used routinely to estimate and manage dosing of medications for their safe and effective use. Such knowledge is useful not only in designing clinical trials for a new molecular entity, but also in day-to-day clinical practice (Box 5.1). 

The broiler industry is extremely cost conscious - a producer will only pay about one cent to medicate the feed for the whole of the 42-day broiler lifespan. Increasing integration in the US broiler industry has led to purchasing power being concentrated in a handful of producers. They have forced prices down so effectively, that despite steady increases in poultry numbers, the market value of this sector continues to fall. These are severe challenges for any prospective new chemical entity - only widespread breakdown of current treatments is likely to change this picture. 

Abridged disclosure PI may be used after 24 months from the date of marketing approval of a new chemical entity in medical publications, except where there is a change of clinical significance. For new chemical entities listed on the PBS, the full PI must be used for at least 12 months from the initial PBS listing date. 

Minimum PI for primary advertisement A primary advertisement is the type of advertisement that is mandatory for advertising of either all new chemical entities or new indications for 24 months from the date of first advertising in medical publications, or longer, at the discretion of the company. Primary advertisements must also be used for at least 12 months after a change of clinical significance made to a product s PI. Primary advertisements may contain promotional claims provided that these adhere to the code, e.g. accurate, substantiated. 

Because the development cycle of OTC drugs is much shorter than that of prescription compounds, the clinician is often able to see an idea of his/her own brought to fruition in the form of an actual product. Typically, it requires only three years or less for the development of an OTC drug, as opposed to 7-10 years for a new chemical entity. The skillful use of medical knowledge and its creative application to new products can make all the difference in the medical and business success of an OTC company. 

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