Pharmaceutics

Excerpt

Pharmaceutics is the overall process of developing a new chemical entity into an approved therapy that is safe and effective in treating or preventing disease. It is a complex process requiring multiple scientific, medical, legal, commercial, and regulatory expertise. On average, it typically takes at least ten years for a new drug to complete the process from initial discovery to the retail marketplace, with clinical trials alone taking six to seven years on average. The Tufts Center for the Study of Drug Development announced that it calculated that it costs pharmaceutical companies $2.6 billion to develop a new drug. This figure has been subject to question, as the raw numbers on which they base the analysis have not been made available. The driving factor of this estimate is the cost of failed drug development attempts, with 80% of new compounds discontinued during their development. The steps involved in bringing a new chemical entity to the market as a drug involve the stages of discovery, chemical optimization and production, preclinical testing, pharmacology, and toxicology testing, early clinical trials establishing proof of concept, registration or pivotal clinical trials showing safety and efficacy in the target patient population and finally regulatory approval.