Pharmacokinetic studies services

Attrition of drug candidates over the course of drug discovery process if the biggest threat plaguing the biopharmaceutical industry. This problem going to increase the cost of drugs and also increase timelines for introduction to 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. 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 significant cause of attrition is due to safety issues arising as a result of animal toxicity testing. Pharmacokinetic profile of the compound is important factor in the assessment of the safety of these compounds. 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 beco pharmacokinetic studies services mes. It is a study of how an organism affects a drug. 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. Much progress has been made in developing 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.

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. The above said aspects can be partially addressed by correlating it with pharmacodynamics 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.

Characterizing the relationship between the pharmacokinetics (PK, concentration vs. time) and pharmacodynamics (PD, effect vs. time) is an important tool in the discovery and 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. 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. Therefore it is important to design robust preclinical studies that will provide information to build mechanistically relevant PK/PD mathematical models. As data becomes available, initial models can be refined through an iterative process. The ultimate output is a powerful predictive tool based on an in-depth understanding of the requirements for efficacy.

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.