Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Review Article Volume 5 Issue 10

Bioavailability, Bioequivalence, and Pharmacokinetics: Clinical Effectiveness in Drug Development

Ghazi M E Hussein1, Heyam Saad Ali2* and Babiker M Elhaj3

1R&D - Pharmacology, JAPAN Division of Pharmacology, Department of Pharmacognosy and Natural Medicines, Kyoto Pharmaceutical University, Japan
2Department of Pharmaceutics, College of Pharmacy, University of Khartoum, Khartoum, Sudan
3Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, University of Science and Technology of Fujairah, Fujairah, UAE

*Corresponding Author: Heyam Saad Ali, Department of Pharmaceutics, College of Pharmacy, University of Khartoum, Khartoum, Sudan.

Received: August 09, 2021; Published: September 25, 2021


Bioequivalence has also been referred to as comparative bioavailability. The concept of bioequivalence started gaining an increased attention during the last three decades, after it became evident that some marketed products containing the same amount of drug and marketed in the same dosage form exhibited marked differences between their therapeutic responses. In many instances, different therapeutic responses observed with these products were correlated successfully to dissimilar levels of drug concentration in the plasma, which was caused mainly due to differences in the rate of absorption of drug from these products. It is now very well established that the rate and extent to which an administered drug dose, to cause a systemic effect, must reach systemic circulation first, therefore its bioavailability depends on a number of very important factors. Although, the previous revisions specifies comparison of pharmaceutical equivalents. It is obvious that pharmaceutical alternatives are also included because the comparison here is also between therapeutic drug ingredients as well.

Conclusion: Bioavailability testing for all products is economically difficult, and for some drugs such studies may not necessarily be essential. The question of determining bioavailability, however, is of particular interest for drug products which fall into distinct categories.

Keywords: Bioequivalence; Bioavailability; Clinical Effectiveness


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Citation: Heyam Saad Ali., et al. “Bioavailability, Bioequivalence, and Pharmacokinetics: Clinical Effectiveness in Drug Development". Acta Scientific Pharmaceutical Sciences 5.10 (2020): 92-100.


Copyright: © 2020 Heyam Saad Ali., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


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