PK services

The biggest problem that is plaguing the pharmaceutical industry is the attrition of drug candidates over the process 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 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. 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. During the in Vivo toxicity testing, major percentage of attrition happens owing to the safely issues. A factor in the assessment of safety during early drug development is the pharmacokinetic profile of the compound. 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.

Over the last few years, Pharmacokinetics has emerged as an integral part of drug development, especially when identifying a drug’s biological properties. 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 are particularly important in the case of assessment of risk in 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. 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 kind of increased emphasis on the PK profile has led to reduction in the termination of programs due to pharmacokinetic profile issues. In turn this has shifted the focus on other compounds being considered unsuitable for drug development. Safety and Efficacy are such reasons. These aspects can be addressed by understanding the complete pharmacokinetic behaviour along with pharmacodynamics 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.

Detailing the relationship between the PK and PD is a critical factor for the development of new drugs. 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 usually very 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 developm PK services ent. 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. Integration of data from different studies in a sequential manner is made possible with the PK-PD models. As a result of the above said factors, PK and PD studies are becoming more important in R and D.