PK studies in India

The biggest problem that is plaguing the pharmaceutical industry is the attrition of drug candidates over the process of drug discovery and development. This problem going to increase the cost of drugs and also increase timelines for introduction to market. Early termination of drug development programmes that will ultimately fail is seen as an approach that leads to overall cost reduction. Understanding of the reasons that contributed to the previous drug failures is required for identifying the possible candidate that will fail. During the in Vivo toxicity testing, major percentage of attrition happens owing to the safely issues. Pharmacokinetic profile of the compound is important factor in the assessment of the safety of these compounds. PK studies in India  Today, Pharmacokinetic studies determine the success or failure of a drug with emphasis on cost, speed and 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 (PK) is dedicated to determining the mechanisms of a drug’s absorption, biodistribution, when it eliminated from the body and what it becomes. It is a study of how an organism affects a drug. These pharmacokinetic processes often referred to as ADME  determine the drug concentration in the body when medicines are prescribed. These are abbreviated as ADME. This is particularly applicable when assessing the risk of a new chemical entity (NCE) in relation to safety parameters such as QT interval prolongation, where free plasma concentrations have been shown to be predictive of this property in relation to potency in preclinical testing. 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. There is a lot of development in tools for the prediction of drug absorption, drug clearance and drug–drug interactions, in addition to the scaling of pharmacokinetic parameters from animals to man. 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. In turn this has shifted the focus on other compounds being considered unsuitable for drug development. Safety and Efficacy are such reasons.  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 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. Additionally, PK/PD modeling can help increase the translation of in vitro compound potency to the in vivo setting, reduce the number of in vivo animal studies, and improve translation of findings from preclinical species into the clinical setting. 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 based on the understanding of the requirements for efficacy is the final output from this work.

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. Applying PK/PD modelling in early discovery and development programs can minimize animal usage, shorten the development time, estimate the therapeutic index, and predict the dose ranges in 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.