World Journal of
Pharmaceutical and Life Sciences

CLINICAL PHARMACOKINETICS CONCEPTS IN THE DRUG DISCOVERY AND DEVELOPMENT PROCESS OF PHYTOMEDICINES IN SOME DEVELOPING COUNTRIES

Tembe Fokunang E. A.*, Fokunang C. N., Ndikum VN, Kaba Nubia C. Andrew Banin, Joseph Fokam, Aubin Nanfack, Ralf Duerr and Miroslaw K. Gorny

ABSTRACT

Clinical Pharmacokinetics can be defined as the study of the relationship between drug dosage regimens and the concentration time profiles. There has been in the last decades a significant progress in the field of Clinical Pharmacokinetics (CPK) in the drug development process and the understanding of the ethical and regulatory demands within the pharmaceutical industries. The three basic parameters that govern PK relationships are Clearance i.e. the volume of the blood that is cleared out completely of the drug per unit time, Distribution volume i.e. the apparent volume in which the drug has been distributed to make the measured concentration and half-life i.e. the time that is required for 50 percent of the drug to be completely eradicated. The knowledge of clearance can be useful in calculating the dose rate needed to retain a target concentration. In addition, elimination half-time helps in determining the time needed for a drug to be completely eliminated from the body. It also indicates the time taken to attain a steady state and can be further used to determine the optimum dosage interval for producing the target peak to trough. On similar lines, essential advancement has been made in the rational design of quinine dosage regimens for patients in places such as Africa and South East Asia. This review paper attempts to discuss ethical issues in clinical Pharmacokinetics in the development of new drugs for poverty related diseases in developing economies. The paper attempts to give an overview of the effect of pharmacokinetics as a factor on therapeutic failure, and how PK can support therapeutic drug monitoring in a clinical setting and its relevance in herbal medicines research. The ethical issues involving PK studies have been discussed.

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