BIOEQUIVALENCE

Presented by:
Ivory Diane C. Amancio, RPh
BS Pharmacy -Clinical Pharmacy
 What is my pill made off?
Active Pharmaceutical
Ingredient (API)
-the one that gives therapeutic action
- The most important component

Excipients
-Filling materials or carrier
substances
-To bulk up or dilute the API
 What is my pill made off?
Active Pharmaceutical
Ingredient (API)
Excipients

Important Note:
Manufacturers must uses always:
-same materials (active and inactive)
-same process
- ensure high quality is consistency

- Final Formulation
 What if I have a generic version
of my Pill are they the same?

Branded
VS
? Generic
Remember:
Active Ingredient --------------- Proof of Bioequivalence
Excipients --------------------- Can differ…
Coating ------------------------ Can differ…
depends on local
Formulation/Shape ------------ Can differ… regulation of Generic
Production Process ------------ differs… drugs)

Quality Control ---------------- GMP requirements

 What is Bioequivalence?
- If two Medicines are Bioequivalent, there is no
clinically significant difference in their
Bioavailability.
VS
Branded Generic
BIOAVAILABILITY
- is a measurement of the extent of a
therapeutically active medicine that reaches the
systemic circulation and is therefore available at
the site of action.
 Branded
VS Generic

Bioavailability is assessed using Three

main Pharmacokinetic Variables:

1. Area under the blood drug concentration

versus time curve (AUC)
2. Time maximum blood concentration (Cmax)
3. Time to reach maximum concentration (Tmax)
 Bioequivalence
Branded -20 % to 25% Generic

√ Bioequivalent
However:
Bio-equivalence is measured only against
the reference drug and not against other
generic drugs.The difference may
be bigger between
each generic and
Generic Generic the original drug.
What does that
mean for
therapy?…
Important Reminder in Generic
Drug Therapy
 Important Reminder in Generic
Drug Therapy
CARE for QUALITY!

Important considerations when using

Generic Drug is Quality Control:

- Same Requirements for Good

Manufacturing Practice or cGMP
Are there
potential effects
of excipients on
bioequivalence
of the drugs?…
 Excipients
-Filling materials
or carrier
substances
-To bulk up or
dilute the API
 Non-Interchangeable
Medicines
Narrow therapeutic
Index (NTI) NTI Drugs Indication
drugs are defined as Carbamazepine Decreasing seizure
those drugs where spread

smaller differences in For seizure

Phenytoin
dose or blood disorders.

concentration may lead Digoxin Antiarrhythmics

to a serous therapeutic Anticoagulants
Warfarin
failures or adverse drug
reactions
Why does branded
drugs has to be
expensive than
generic drugs?
P 3.15

P 2.80

P 1.50
Stages of Drug Development
Stages of Drug Development
Thank you for
Listening!