Bio-equivalence study of drugs: Let us know the Biopharmaceutical Classification System, why do we require a Bioequivalence study, and regulatory requirements.

1. INTRODUCTION

2. Biopharmaceutical Classification System (BCS)
BCS Permeabilit
y
Solubility Remarks
Class I High High Those compounds are well absorbed and their
absorption rate is usuallyhigher than excretion
Class II High Low Bioavailability of those products is limited by their
solvation rate
A correlation between the in vivo bioavailability and
the in vitro solvation can be found
Class III Low High Absorption is limitedby the permeation rate but
the drug is solvated very fast. If the formulation
does not change the permeability or gastro-intestinal
duration time,then class I criteria can be applied.
Class IV Low Low Those compounds have a poor bioavailability.
Usuallythey are not well absorbed over the
intestinal mucosa and a high variability is expected.

3. Introduction
India adores a very
significant position in the
global pharmaceuticals
market.

4. ADVANTAGE INDIA
With 1.3 billion people and
wide variety of diseases and
patient pool makes this
country very attractive to the
pharmaceutical companies

5. ADVANTAGE INDIA
Besides large and diverse
patient pool, we also have a
large pool of pharmacist,
scientists and engineers

6. ADVANTAGE INDIA
India is the largest provider
of generic drugs globally
with the Indian generics
accounting for 20% of global
exports in terms of volume

7. BIOAVAILABILITY STUDY REPORTS
REGULATORY REQUIREMENTS
Besides New Drugs, the following
are the areas where
Bioavailability/Bioequivalence study
reports are essential as per
regulatory requirements-
1. FDC (Fixed Dose Combination)
as per approved lists

8. BIOAVAILABILITY STUDY REPORTS REGULATORY
REQUIREMENTS
Besides New Drugs, the following
are the areas where
Bioavailability/Bioequivalence study
reports are essential as per
regulatory requirements-
2. SR (Sustained Release) Products

9. BIOAVAILABILITY STUDY REPORTS REGULATORY
REQUIREMENTS
Besides New Drugs, the following
are the areas where
Bioavailability/Bioequivalence study
reports are essential as per
regulatory requirements-
3. As per the Gazette Notification
[GSR-327(E) dated 3rd April 2017]
regarding BCS Classification

10. BIOAVAILABILITY STUDY REPORTS REGULATORY
REQUIREMENTS
• Besides New Drugs, the following are
the areas where
Bioavailability/Bioequivalence study
reports are essential as per regulatory
requirements-
4. As directed by regulatory Authority