Pharmacokinetic studies in maryland

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 significantly increases the cost and delays the launch of product in the market. Early termination of drug development programmes that will ultimately fail is seen as an approach that leads to overall cost reduction. 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. 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 (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 four processes together are 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. 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. Hence, In vivo pharmacokinetic (PK) screening can be instrumental in the selection of lead compounds with desirable bioavailability profiles for further investigation in 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 in turn has highlighted the other causes for compounds being considered unsuitable for drug development. Such reasons include inadequate 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. Rational study design is based on the assumption of a causal relationship between exposure to a medication and its 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. Pharmacokinetic studies in maryland  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.

A well designed PK/PD will offer logical approach to understand the mechanism of action of drug and select the most optimal approach. 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 allow integration of data from different studies in a logical manner based on the understanding of drug and disease. So, Pharmacokinetics and Pharmacodynamics are becoming increasingly important in the drug discovery process.