Pharmacokinetic studies in Boston MA

The challenge faced by the bio-pharmaceutical industry is the attrition that the drug candidates face over the course of drug discovery and development. The cost and timelines are adversely affected creating loss to the companies and huge impact on the quality of life at large. An early termination of a drug development program that will fail will help pharmaceutical companies in reducing the overall cost of R and D. For abandoning the possible failure candidate, it is important to understand the factors that have contributed to the failure of the products in the past. A major reason for this attrition is the safety issues that arise during the animal toxicity testing. Pharmacokinetic profile of the compound is important factor in the assessment of the safety of these compounds. Pharmacokinetic studies have become the most important factor in determining the success of the drug due to its impact on the cost and ability to predict the drug properties with great levels of accuracy.

Pharmacokinetics has become an intricate part of the drug discovery process. It is particularly useful for finding out the biological properties of the Drug. Pharmacokinetics provides a mathematical basis to assess the time course of drugs and their effects in the body. It enables the following processes to be quantified: Absorption, Distribution, Metabolism, and Excretion. These four processes are usually called as ADME These factors become critical in the case of assessing risk in a new chemical entity often abbreviated as NCEs. The undesired PK characteristics include low bioavailability due to high extraction or poor absorption characteristics, short elimination half-life leading to short duration of action and excessive variability due to genetic or environmental factors. Many tools have been developed for predicting drug absorption, drug clearance and drug-drug interaction. Along with this PK parameters from animals to man have also been introduced. The resultant PK screening can be instrumental in selection of lead compounds when with the wanted bioavailability characteristics and will help in the further drug development programs.

This increased consideration of the suitability of the pharmacokinetic profile has led to a reduction in the early termination of programmes due to pharmacokinetic failings. This in turn has highlighted the other causes for compounds being considered unsuitable for drug development. Such reasons include inadequate safety and efficacy.  Both of these aspects can be partially addressed by extending the prediction of pharmacokinetic behaviour to include the pharmacodynamic profile of the drug candidate. Preclinical pharmacodynamics studies and the identification of appropriate safety and efficacy biomarkers provide avenues to increase the confidence in rationale and safety of new drug molecules.

Drawing inferences from the correlation between the Pharacokinetics and Pharmacokinetics is an important tool that is emerging. Also, the PK/PD modelling can help in increasing the conversion rates from in vitro to in vivo to further these findings in preclinical and clinical setti Pharmacokinetic studies in Boston MA ngs. The studies are designed with the basic assumptions of understanding relationship between the exposure of the medication and associated therapeutic activity. Such relationships are generally complex. So, it is important that we design preclinical models that will provide information about mechanistically relevant PK/PD models. As data becomes available, initial models can be refined through an iterative process. A predictive tool based on the understanding of the requirements for efficacy is the final output from this work.

A well designed PK/PD will offer logical approach to understand the mechanism of action of drug and select the most optimal approach. Allocation of PK/PD modelling in the development programs ca help in minimization of in vivo models in the later phase and predict the dosage ranges for early clinical testing. PK-PD models help in the aggregation of data from various studies and help in deeper understanding of relationship between drug and the disease. As the result of the above said reasons, PK and PD are becoming more and more important in the drug R and D.