Bioavability and Bioequalance

1. Submitted to Mr. Manoj Bhardwaj
Submitted by Mohammad shafique ansari

2. Bioavailability may be simply
explained as the rate and
extent of a drug substance from
a drug product or dosage form
into the inner compartment of
the human body.

3. OBJECTIVE OF BIOAVAILABILITY
 Development of new formulation of the existing drug
 Control of quality of a drug product during the early
stages of marketing in order to determine the
influence of the processing factor, storage and stability
on a drug absorption.
 Primary stage of development of a suitable dosage
form for a new drug entity to obtain evidence of its
therapeutic utility.

4. Consideration in in-vivo
Bioavailability
 Absolute Bioavailability
 Relative Bioavailability

5. MEASUREMENT OF
BIOAVAILABILITY
 Pharmacokinetic
method
1. Plasma level time
studies
2. Urinary excretion
studies
 Pharmacodynamic
method
1. Acute pharmacological
response
2. Therapeutic response

6. Plasma level time studies

7. Urinary Excretion Data
 These studies are based on the principle that urinary
excretion of the unchanged drug is directly proportional to
the plasma concentration of total drug
 This technique of studying bioavailability is most useful for
those drugs that are not extensively metabolized prior to
urinary elimination.

8. Urinary excretion

9. Pharmacodynamic method
 Acute pharmacological effect such as a change in ECG
or EEG reading, pupil diameter, drug response curve.
 Therapeutic Response Method: Clinical response of
the drug for which it is intended to be used is
measured.
 E.g.: heart rate, body temperature, blood sugar levels,
and for anti-inflammatory drugs, reduction in
inflammation is determined

10. IN VITRO DRUG DISSOLUTION RATE
BIOAVAILBILTY
1. Basket apparatus (apparatus 1)
2. Paddle apparatus (apparatus 2)
3. Reciprocating cylinder apparatus (apparatus 3)
4. Flow through cell apparatus (apparatus 4)
5. Paddle over disc apparatus (apparatus 5)
6. Cylinder apparatus (apparatus 6)
7. Reciprocating disc apparatus (apparatus 7)

11. IN VITRO DISSOLUTION TESTING
MODELS
1. Factor relating to the dissolution apparatus
2. Factor relating to the dissolution fluid
3. Process parameter

12. IN VITRO-IN VIVO CORRELATION
(IVIVC)
 Is defined as the predictive mathematical model that
describes the relationship between an in vitro property
(such as the rate and extent of dissolution ) of a dosage
form and an in-vivo response (such as the plasma drug
concentration or amount of drug absorbed.)

13. BIOPHARMACEUTICS
CLASSIFICATION SYSTEM FOR
DRUG

14. BIOAVAILABILITY STUDY PROTOCOL
 A study objective
 B study design
1. Experimental design
2. Wash out period
3. Drug product (i) test product (ii) recognized stn.
4. Rout of administration
5. Dosage regimen
6. Frequency and duration of sampling
7. Randomization of drug administration
8. Single versus multiple dose study design

15. B.
9. subjects
(a) Healthy subject versus patients
(b) subject selection
(i) medical history
(ii) physical examination
(iii) laboratory tests
(c) Study conditions
10 . Analysis of biological fluids

16. C.METHODS OF ASSESSMENT OF
BIOAVAILABILITY
1. Plasma data
2. Urine data
3. Acute pharmacological effect
4. Clinical response

17. D. ANALYSIS AND PRESENTATION
OF DATA
1. Statistical treatment of data anlysis of variance
2. Format of data

18. BIOEQUIVALANCE
 Equivalence – Equivalence is more relative term that compares
one drug product with another or with a set of established
standards. Equivalence may be defined in several ways:
 Chemical equivalence indicates that two or more dosage forms
contain the labeled quantities of drug.
 Clinical equivalence occurs when the same drug from two or
more dosage forms gives identical in vivo effects as measured
by a pharmacological response or by control of a symptom or a
disease.
 Therapeutic equivalence implies that one structurally different
chemical can yield the Same.