Medical Implications Of Clinical Pharmacokinetic Studies

The Indian clinical landscape has evolved over the past few years with massive developments in science and technology

. As a result of which India is gradually becoming the hub for medical studies, experimentations and varied clinical trials. The objective of most clinical trials is to come up with new treatment methods, drug development techniques and also assess how much of the drug needs to be consumed by an individual and the impact of that drug in the patient"s blood and nerves. Over the past few years various critical and important medical studies and researches have been conducted. Of them one of the important names that deserve mention is the field of Clinical Pharmacokinetic studies.

What is Clinical Pharmacokinetic?

Simply put, Clinical Pharmacokinetic is a branch of medical study that is conducted in order to assess the distribution, absorption, metabolism and excretion of a drug under an investigation both in healthy patients and volunteers. The information that is gathered from this study has proved to be useful in designing and conducting subsequent clinical trials. They are also crucial for atp analysis and assessment of the safety and efficacy from the data generated in clinical trials for new drug development and post-marketing clinical trials. The result of non-clinical pharmacological and toxicological studies need to be assessed in conjunction with the outcome of non-clinical and clinical pharmacokinetic studies offer valuable data for the apt and safe conduct of clinical trials and for the estimation of the mechanism of action in humans.

Usages of Clinical Pharmacokinetic studies

The results of Clinical Pharmacokinetic studies have proven useful in determining the apt use of medicines as per the patient characteristics, for instance the disease and genotype of the drug metabolizing enzymes and for predicting the impact of Pharmacokinetic drug interactions. The outcome can also offer data for therapeutic drug monitoring (TDM). It is essential to assess Pharmacokinetic parameters of the individual volunteers and patients in close association with the drug efficacy and unfavorable drug reactions observed in every subject. The chemical and physical properties, toxicity, Pharmacokinetics, pharmacological drugs and its use in clinical trials would vary from two separate investigational drugs. It is hence essential to execute the apt development strategy for every investigational drug.

Today Clinical Pharmacokinetic studies carried on by Clinical Research Organizations implements apt methodologies that need to be selected as per the inherent aspects of the investigational drug taking complete advantage of the present data from both the non-clinical as well as clinical studies. There can be a need for additional studies, so that a better new medicine development can be achieved by avoiding pointless studies and researches.

by: Gladeyas

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