purpose of bioavailability studie Biopharmaceutics Dosages form design

1. Dosage Form Design
Presentation on
Purpose of Bioavailability or
Bioequivalence Studies
Prepared by:-
Sukesh Kumar Yadav
Roll No. :- 28
Shivcharan Mandal
Roll No. :- 25
ACAS, B. Pharmacy

2. Purpose Or objective of Bioavailability studies
 Bioavailability studies are important in the —
1. Primary stages of development of a suitable dosage
form for a new drug entity to obtain evidence of its
therapeutic utility.
2. A drug product’s bioavailability provides an estimate of
the relative fraction of the administered dose that is
absorbed into the systemic circulation.
3. Bioavailability and bioequivalence studies are
important in the process of approving pharmaceutical
products for marketing.
4. Bioavailability data provide an estimate of the fraction
of drug absorbed from the formulation, and provide
information about the pharmacokinetics of the drug.

3. 5. Determination of influence of excipients, patient
related factors and possible interaction with other
drugs on the efficiency of absorption.
6. Development of new formulations of the existing
drugs.
7. Control of quality of a drug product during the early
stages of marketing in order to determine the
influence of processing factors, storage and stability
on drug absorption.
8. Comparison of availability of a drug substance from
different dosage forms or from the same dosage
form produced by different manufacturers.

4.  Determining the fraction (f) of administered dose
absorbed involves comparing the drug product’s
systemic exposure (represented by the concentration-
versus-time or pharmacokinetic profile) with that of a
suitable reference product.
 For systemically available drug products, bioavailability
is most often assessed by determining the area under
the drug plasma concentration-versus-time profile
(AUC).
 The AUC is considered the most reliable measure of a
drug’s bioavailability, as it is directly proportional to the
total amount of unchanged drug that reaches the
systemic circulation

5. Fig: concentration-versus-time or pharmacokinetic profile

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