Toxicology

Toxicology is the scientific discipline which detects, measures and studies the effects of chemicals and drugs on biological systems. Drugs and new chemical entities can have both a positive and a negative impact. Within the pharmaceutical industry, it is of course necessary to determine that any drug in the process of development, either synthetic or natural, does not have a toxic impact on the human physiological system. It is an essential component of the commercial pharmaceutical research and development process.

Pharmaceutical toxicology is a multidisciplinary science and is inextricably linked to synthetic chemistry, computational chemistry, proteomics, metabolomics, drug discovery and drug metabolism. Scientific disciplines that are relating include bioinformatics, bioanalytical chemistry, chemical biology and molecular epidemiology.

At PharmaDirections, we have fully qualified and board certified toxicologists who can design and direct toxicology studies for either a non-GLP candidate vetting, or for GLP studies as part of IND enabling programs. Toxicology studies are placed at “Best of Breed” contract research organizations. It is here that Senior Associates in Toxicology from PharmaDirections will oversee the work, interpret the data and provide professional analysis regarding the value of the information. A small IND enabling program team is also available to take the scientific lead with the CROs when clients need to outsource this type of program. Studies that we commonly place and manage are:

• Genetic Toxicology
• Single dose and multi dose ranging studies
• GLP acute toxicity
• GLP chronic toxicity
• Toxicokinetics
• Reproductive Toxicity
• Carcinogenicity
• Bioanalytical method development and validation
• Bioanalysis