CRO for pharmacokinetics

Attrition of drug candidates over the course of drug discovery process if the biggest threat plaguing the biopharmaceutical industry. 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 drug development program that will fail will help pharmaceutical companies in reducing the overall cost of R and D. 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. Pharmacokinetic profile of the compound is important factor in the assessment of the safety of these compounds. PK studies now help in determining the success of the drug with ability to accurately predict the drug properties and also curtail the costs of resea CRO for pharmacokinetics rch.

Pharmacokinetics has become an intricate part of the drug discovery process. It is particularly useful for finding out the biological properties of the Drug. PK studies help in determination of drug absorption, distribution and how it gets excreted from the body and what it becomes over this journey. These processes are together abbreviated as ADME These factors become critical in the case of assessing risk in a new chemical entity often abbreviated as NCEs. Inappropriate pharmacokinetic behaviour includes such factors 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. 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 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. Pharmacodynamic studies along with identification of suitable biomarkers pertaining to the safety and efficacy help in the safety profiling the drug candidate.

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. PK/PD modeling can also help in translating the in vitro compound potency from all the way from in vitro setting to clinical phases. The studies are designed with the basic assumptions of understanding relationship between the exposure of the medication and associated therapeutic activity. It is observed that such relationships are very complex. We see that such relationships are really complex. Therefore it is important to design robust preclinical studies that will provide information to build mechanistically relevant PK/PD mathematical models. A data becomes more available, the initial models can be refined further. 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. 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. Integration of data from different studies in a sequential manner is made possible with the PK-PD models. As the result of the above said reasons, PK and PD are becoming more and more important in the drug R and D.