Author: Unknown
•9:04 PM
By Esther Salazar


Clinical pharmacokinetics research is a medical investigation on actual reactions of the human body upon administration of drug serum concentration. This is vital for approved drugs re-examination and for new drug applications submission. This is performed to ensure the appropriate use of medicines and obtain definite human pharmacokinetic information necessary for the progression of drugs being tested.

A clinical pharmacokinetic research is often done by a number of qualified individuals that similar competence in the field. It aims to provide credibility, maintain standard of quality and improve performance of drug usage. In the investigational process, excretion and metabolism of drugs are examined by means of a linear equation for pharmacokinetic one-compartment model. Data obtained are used in creating of appropriate design for a clinical trial where healthy patients or volunteers will be tested.

The study will serve as the groundwork for new drug development and post-marketing clinical trial. Evaluation and analysis of the safety and efficacy of administered serum will be used in determining appropriate use of the medicine to patients with certain types of diseases. Results are very important in therapeutic drug monitoring, a branch of chemistry that focuses on the measurement of drug concentrations in the blood.

The physical and chemical elements of the drug will differ significantly along with its toxicity, pharmacological actions and pharmacokinetics. That is why it is imperative for the new or approved drug researcher to implement proper development plan in an effort to obtain accurate data for both investigational drugs. This document may, however, be unequally applicable for each drug under investigation.

For serum concentrations evaluated through the implementation of gene technology, researchers are accordingly advised to follow through indicated principles for safe calculation on biotechnology-derived drug. Appropriate method critical to the drug's inherent substances should be used all through the research although researchers still need to utilize existing information obtained in other studies.

Three cardinal parameters are typically investigated along with the serum concentration dynamics and time profile; the distribution volume, elimination of half-life and clearance. The distribution volume is the actual amount of drug distributed for measured concentration while clearance is the level of fluid being cleared out in every unit time. The elimination half-life is the time by which half the about amount of drug is eliminated.

Being able to uncover the distribution volume can help gauge the loading dose of drugs while at the same have an idea on the safe dose rate of the amount retained on target concentration. The elimination half-time can help ascertain the required time of the drug to perfectly blend in the system.

Compliance with the good practice is imperative. The ordinance specified for pharmacokinietic studies should be followed meticulously in order to achieve safety of the trial subjects and ensure scientific quality. Careful observance to the ordinance will also protect human rights not only in the hands of researchers.

Recently, clinical pharmacokinetics investigations have had incremental progress particularly in the creation of dosage regimen design intended to treat tropical ailments like chronic malaria. Also, essential advancements have been made in creating rational design for quinine dosage regimens.




About the Author:



|
This entry was posted on 9:04 PM and is filed under . You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

0 nhận xét: