This document discusses bioequivalence and its assessment. It defines bioequivalence as two identical drug products reaching systemic circulation at the same rate and extent. Bioequivalence can be assessed through in vivo and in vitro studies. In vivo studies measure absorption rate, percentage absorbed, and pharmacokinetic parameters while in vitro studies examine dissolution rate and percentage dissolved. Parameters like Cmax and AUC are used to determine if products are bioequivalent. Bioequivalence studies allow generic drugs to be approved without new clinical trials, reducing costs.

1. BY NEERAJ PANDEY
M PHARM (PHARMACEUTICS)
RITM LUCKNOW.

2.  EQUIVALENCE.
 BIOEQUIVALANCE.
 FLOW CHART.
 GRAPH
 TYPES OF BIOEQUIVALENCE.
 IN VIVO STUDIES.
 IN VITRO STUDIES.
 PARAMETER OF CORRELATION.
 METHOD TO ASESS BIOEQUIVALANCE.
 ADVANTAGE.
 DISADVANTAGE.
 CONCLUSION.

3.  Equivalence is a relative term which
compares drug product with respect to
specific characteristic or function.
 Types of equivalence
i. Chemical equivalence.
ii. Pharmaceutical equivalence.
iii. Bio equivalence.
iv. Therapeutic equivalence.

4.  Bioequivalence refers to the drug substances
in two or more identical dosage forms,
reaches the systemic circulation at the same
rate and same relative extent.
 Example- The plasma concentration-time
profile will be identical without significant
differences.

7.  IN VIVO STUDIES
 IN VITRO STUDIES

8.  Oral immediate release product with systemic
action.
i. Narrow therapeutic response.
ii. Absorption<70% or nonlinear kinetics, pre
systemic elimination >70%.
iii. Documented evidence for bioavailability
problem.
iv. Unfavorable physiochemical properties e.g.
low solubility, instability etc.
v. No relevant data available.
 Non oral immediate release product.
 Modified release product with oral action.

9. o The drug product differ only in strength of
active substance it contain following
condition same
I. Pharmacokinetics are linear.
II. The qualitative composition is same.
III. The ration between active substance and
excipient is same.
IV. Both product are made by same
manufacturer at same manufacturing site.

10. V- A bioavailability or bioequivalence study has
been performed with the original product
Vi- In vitro dissolution rate is same
o The product is slightly reformulated or the
manufacturing method has been slightly
modified.
o The drug product meet following requirement
i. Solution or solubilized form.
ii. Active ingredients in same concentration as
approved drug.
iii. Contain no excipients known to significantly
effect absorption of active ingredients.

11. IN VIVO STUDIES IN VITRO STUDIES
 Absorption Rate
 Percentage Drug
Absorbed
 C max serum drug
concentration
 Dissolution Rate
 Percentage Drug
Dissolved
 Studies Performed In
Laboratory

12.  Pharmacokinetic method
 Plasma level-time studies.
i. Trapezoidal method
ii. Cut and weigh method
 Urinary excretion studies.
 Pharmacodynamics method.
I. Acute pharmacological response.
II. Therapeutic Response’

14.  Minimize the effect of inter subject
variability.
 It minimize the carryover effect.
 Require less no of subject to get meaningful
result.

15.  Require longer time to complete the
studies.
 Increase in period leads to high subject
dropouts.
 Medical ethics does not allow too many trials
on a subject continuously for a longer time.

16.  Bioequivalence is used mainly for the generic
drug for reducing its cost because if the drug
is only proved to be equivalent to its brand
previously approved drug then there is no
need to perform the clinical trial and it is
also used to minimize difference between
batches of same drug.