Pharmacokinetics In Drug Discovery And Development - Research Paper Example

The use of surrogates and the biomarkers in the drug development, integration of the pharmacogenomics into the PK/PD relationship, the outcome models, mechanistic models, and the disease progression models are the basis for the clinical trial simulations. There are many PK/PD models for drug development. Among the models, the disease progression model is widely used for the study of the disease trajectory. The level of safety of the model is then analyzed, followed by the validation models. These models give us the idea about the exposure /response relationshipThe pharmacokinetic studies are usually conducted based on the traditional intensive design of carefully selecting the volunteer subjects as a controlled experimental design by collecting multiple blood samples.

The drug administered is then analyzed. The measurement of the drug and its metabolite concentration in all the blood samples is the first step in the pharmacokinetic studies. Then the pharmacokinetic model is applied to determine the parameters such as the volume of distribution, half-life of the drug and the total clearance from the body. When a new drug is developed, the effect of the drug on the major disease states is studied using the pharmacokinetic studies. The pharmacokinetic studies are also conducted to determine the effect of the drug disposition for the hypothesized experimental conditions (1).

The factors that are considered are age, body weight, ethnicity, gender, renal and hepatic disease, co-administration of the drugs and other drug interactions. The unexpected factors that affect the pharmacokinetic studies cannot be identified by the classical pharmacokinetics but it can identify the effects of the anticipated influences on the drug disposition at controlled stages (2). A lot of examples is posted for the altered drug pharmacokinetics in patient care.