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:- 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:-

  1. 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.
  2. 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

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