Pharmaceutical research plays an essential role in the development of new drug molecules for safe and effective use in patients. Pre-clinical and clinical research are two important phases in drug discovery and development process. It takes about 12 to 16 years to bring a molecule from laboratory to clinical practice. Based on the type of drug molecule,the duration of pre-clinical research varies from 2 to 6 years while clinical research takes approximately 7 to 12 years. Today the challenge with pharmaceutical research is to reduce the lead time of pre-clinical and clinical phases, which can be made possible by adopting newer technologies, using rational drug design process in place of traditional processes.
Pre-clinical research is combination of in vitro, in vivo and ex vivo experiments before the clinical trials. Target identification, target validation, lead identification, lead optimization and finally synthesis of the new drug molecule for a specific disease are important steps of pre-clinical research. After the synthesis of a drug molecule, different tests and experiments are done in laboratory and animal models for the collection of safety and efficacy information for the clinical trials. The primary objective of pre-clinical research is identification of physiological, toxicological and efficacious potential of drug molecule. Study of pharmacodynamics, pharmacokinetics, immunogenicity, immunotoxicity, developmental toxicity, genotoxicitystudies and carcinogenicity properties with identification of initial safe dose, target organs and other safety parameters constitute secondary objectives. Regulatory authorities wants to minimize the use of animals in pre-clinical trials due to animal rights issues, so selection of animals for the pre-clinical trials is another important aspect, normally one rodent and one non-rodent species are used for the same. High quality safety and efficacy data is required by the regulatory authorities before giving approval for conduct of clinical trials in humans in the form of IND (New Drug Application) submission.
