Pharmacokinetic studies in Australia

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Current revision as of 13:20, 9 January 2019

The problem faced by pharmaceutical companies is the drug candidate attrition throughout the drug discovery and development process. 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. An understanding of the reasons that contributed to the drug development failures is important for determining which drug candidate will fail. 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. 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 processes are together abbreviated as ADME This is particularly applicable when assessing the risk of a new chemical entity (NCE) in relation to safety parameters such as QT interval prolongation, where free plasma concentrations have been shown to be predictive of this property in relation to potency in preclinical testing. 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. Many tools have been developed for predicting drug absorption, drug clearance and drug-drug interaction. Along with this PK parameters from animals to man have also been introduced. 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 resulted in the emphasis on other causes for compounds being considered unsuitable for drug development like safety and efficacy. These aspects can be addressed by understanding the complete pharmacokinetic behaviour along with pharmacodynamics 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.
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. It is observed that such relationships are very complex. We see that such relationships are really complex. So, we have to develop a dynamic preclinical studies model that will provide information to build a mathematical and mechanistically relevant PK/PD mod Pharmacokinetic studies in Australia els. 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. 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. 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.
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