Pharmacokinetic studies in India
The problem faced by pharmaceutical companies is the drug candidate attrition throughout the drug discovery and development process. Pharmacokinetic studies in India This problem significantly increases the cost and delays the launch of product in the market. An early termination of a candidate without the expected qualities will help in reduction of the overall cost of drug R and D. This approach has been proven effective by multiple studies. An understanding of the reasons that contributed to the drug development failures is important for determining which drug candidate will fail. A significant cause of attrition is due to safety issues arising as a result of animal toxicity testing. The PK profile of the compound is an important factor to determine the safety during the early stages of drug development. In the current atmosphere of drug R and D, PK studies play an important role in determining the success or failure of the drug. It also helps us control the cost and pace of the research.
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. Undesired PK behaviour includes factors such as 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. As we see the resultant PK screening results can be used in the selecting a lead compound with desired bioavailability profile. This information can be used in furthering the drug discovery programs.
There has been a rise in consideration of suitability of the PK profile of the drug candidate. This has led to the decrease in the early termination of the programs due to pharmacokinetic failings. This resulted in the emphasis on other causes for compounds being considered unsuitable for drug development like safety and efficacy. These aspects can be addressed by understanding the complete pharmacokinetic behaviour along with pharmacodynamics profile of the drug candidate. Preclinical PD studies and the safety and efficacy biomarkers provide depth of data and help in assessment of safety of the drug candidates.
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 settings. We build the study designs with an assumption to study the relationship between medical exposure and therapeutic activity. Such relationships are generally complex. So, we have to develop a dynamic preclinical studies model that will provide information to build a mathematical and mechanistically relevant PK/PD models. Based on the data from these models, we can further refine the basic models of study. A predictive tool that can have an in-depth understanding about the efficacy requirements is the ultimate output that we get from this exercise.
Well planned PK/PD study offers a rational approach to the efficient and informative drug development. This will help the teams in understanding the mechanism of action of a drug. Thus helping us to select the most optimal drug. 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 allow integration of data from different studies in a logical manner based on the understanding of drug and disease. As a result of the above said factors, PK and PD studies are becoming more important in R and D.
