"Pharmacokinetic studies in India515"의 두 판 사이의 차이

2019년 1월 9일 (수) 15:59 기준 최신판

The attrition of drug candidates during the long process of drug discovery and development is the issue that is faced by the pharmaceutical industry today. 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. In order to achieve this it is important to understand the root causes of attrition that have led to drug development failure in the past. The attrition happens at the level of animal testing for toxicity where the safely issues play an important role Pharmacokinetic profile of the compound is important factor in the assessment of the safety of these compounds. In the current atmosphere of drug R and D, PK studies play an important role in determining the success or failure of the drug. It also helps us control the cost and pace of the research.

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 four processes together are called as ADME. These factors are particularly important in the case of assessment of risk in 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. 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. As a result, PK screening is instrumental in selection of lead compounds with the expected bioavailability profiles for taking the drug discovery process further.

This kind of increased emphasis on the PK profile has led to reduction in the termination of programs due to pharmacokinetic profile issues. This resulted in the emphasis on other causes for compounds being considered unsuitable for drug development like safety and efficacy.  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. Also, the PK/PD modelling can help in increasing the conversion rates from in vitro to in vivo to further these findings in preclinical and clinical settings. We build the study designs with an assumption to study the relationship between medical exposure and therapeutic activity. Such relationships are generally complex. So, it is important that we design preclinical models that will provide information about 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 development. This will help the teams in understanding the mechanism of action of Pharmacokinetic studies in India  a drug. Thus helping us to select the most optimal drug. Application of PK/PD modelling in the early discovery can minimise the animal usage and predict the dosage range right from 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 a result of the above said factors, PK and PD studies are becoming more important in R and D.