Pre-clinical testing is performed to Good laboratory...

Pre-clinical testing is performed to Good laboratory practice (GLP) and covers pivotal toxicology safety pharmacology studies. In preclinical research, scientists test their ideas for new biomedical prevention strategies in laboratory experiments or in animals. â€Å"Pharmacokinetics (PK) and pharmacodynamics (PD) can be seen as two sides of the same coin. PK and PD have a definite relationship, assessing how much drug gets to the site of action and then what that action is. Both activities are essential in the complete investigation of the interaction between the drug and body, and play significant roles in both drug development and their continual use in the clinical setting (Institute Of Clinical Research, Clinical Pharmacology Special†¦show more content†¦These data are used on anticipated manner that scientist will able to compare pharmacokinetic and toxicokinetics at the stages of drug development for efficacy and/or safety evaluation. With the help of preclinical data, researcher able to assess the safety of the product for initial testing in human. To understand a disease and effective medical treatment of that disease, animal research considered vital for clinical research. Each year, millions of medical tests are performed on animals for the purpose of advancing research. To register of any investigational product for human use the FDA or other regulatory authorities require data from acute toxicity studies. Generally the data obtained from theses preclinical studies are used to set maximum dose level for repeat dose studies in animals to support the effects of overdose in humans or any organ toxicity by comparing minimum lethal dose and maximum non-lethal dose. The usage of acute toxicity data are very limited in terms of focusing on minimum lethal and maximum non-lethal doses effects. â€Å"Of less use than other, less harmful, animal tests that are superior for deciding appropriate doses for further animal studies. Not particularly useful for information on the nature of toxic effects, which are better evaluated in other routine studies. Not, in practice, used to set doses in the first human clinical trials because other routine studies provide more informative data (Challenging requirement for