These concepts can be approached theoretically as well as in nonclinical pharmacological studies. While efficacy and safety in humans cannot be assured by studies in animals, some comfort level can be achieved by the use of animal models of toxicology. The second element, is for the program to be run with solid medical principles, or “good medicine.” The main principle is to do no harm. Inhibitors,research,lifescience,medical No clinical program should knowingly put, any clinical trial subject at risk of harm. Proper

clinical trial designs should be based on acceptable methods with a profound understanding of the disease under study. When adverse events appear, a conscientious evaluation of their significance to the individual patient as well as to the population at large, must be performed. The third element in drug development is to assure compliance with regulatory requirements, Inhibitors,research,lifescience,medical or “good regulations.” Fulfillment of regulatory requirements is in addition to fulfillment of the requirements of “good science” and “good medicine.” The regulations ensure that regulatory bodies such as the Food and Drug Administration (FDA) can

properly review and evaluate a drug development program in a standardized manner. The team The drug development team includes a diverse group of individuals Inhibitors,research,lifescience,medical with different philosophies and approaches to the development process. All team members must work closely together to ensure that a drug is both safe and efficacious. Discovery/development The discovery and development groups are comprised Inhibitors,research,lifescience,medical of the basic scientists and chemists who created the new molecule. This group synthesizes drug substances for “drug-screening,” pharmacology, and toxicology studies, and also prepares clinical supplies. Nonclinical pharmacology and toxicology This group studies the drug product in animal models of efficacy and safety in order to identify potential efficacy and safety issues in humans. It is critical for the clinical and development groups to work closely with the lexicologists in the design of animal studies to ensure their relevance

to the clinical environment. Clinical Inhibitors,research,lifescience,medical research Clinical research has the ultimate responsibility for testing drug products in humans: the monitoring of drug safety rests MEK inhibitor squarely on the shoulders of clinical research. Clinical trials must be science-based with proper statistical methodologies and have clinically relevant end points. Clinical research interacts directly with the FDA and however is responsible for the generation of study reports with input from biostatisticians and regulatory affairs. Clinical research can also generate the publications necessary for the marketing of any drug product. Regulatory affairs The regulatory affairs department is the interface with the FDA. It is their responsibility to ensure compliance with the rules and regulations established by the Federal Food Drug and Cosmetic Act (FDCA)1 and its amendments.