Chapter 10
Bioavailability Studies
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Bioavailability Studies
Student Objectives for this Chapter
After completing the material in this chapter each student should:-
- be able to define various terms relating to bioavailability studies
- be able to describe some of the past problems with bioavailability
- be able to describe a typical bioavailability study
- be able to evaluate data derived from a bioavailability study
The topic of this Chapter is studies which are carried out to evaluate different dosage forms. These studies called bioavailability or drug product
evaluation studies might compare:-
- two (or more) dosage forms made by two (or more) different manufacturers, e.g. innovator versus generic. These studies are called bioequivalence studies and they look at the similarity of F and ka values between the products studied.
- one type of dosage form with a 'standard' formulation, e.g. tablet versus intravenous or capsule versus solution. These are bioavailability studies designed to determine values of ka and F for the product under study. Changes in ka may be intentional (for slow release dosage forms). The F value may need to be determined.
Second brand or generic drug manufacturers are required to prove that
their product is equivalent to previously marketed products which have
demonstrated clinical efficacy. For most drugs, the second and subsequent
manufacturer must show that their product is bioequivalent, i.e. same ka and F,
as the product(s) on the market. During the development of new drugs and drug
products, the original manufacturer will perform bioavailability studies on new products, comparing the product to be marketed with an intravenous dosage form, if possible.
References
- Albert, K.S. 1980 Drug Absorption and
Disposition: Statistical Considerations Amer. Pharm. Assoc.
- Dittert, L.W. et al. 1972 Guidelines for Biopharmaceutical
Studies in Man Amer. Pharm. Assoc.
- U.S. Food and Drug Administration (FDA)
- Schedule of Pharmaceutical Benefits for Approved Pharmacists and Medical Practitioners from the Australian Department of Health and Ageing... note the equivalence symbol 'a'
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