Introduction of Research methodology

1. Drug Design & Development
By
Dr. Priyank Purohit
M.S , PhD (NIPER Mohali )
Associate Professor
Graphic Era Hill University 1

2. DRUG DESIGN & DEVELOPMENT
2

3. 3

4. 4

5. 5

6. DRUG DESIGN
• Drug design is the inventive process of finding
new medications based on the knowledge of a
biological target.
• The drug is most commonly an organic small
molecule that activates or inhibits the function of
a biomolecule such as a protein, which in turn
results in a therapeutic benefit to the patient.
6

7. 7

8. DRUG DESIGN
8

9. DRUG DEVELOPMENT
9

10. DRUG IN MARKET
10

11. CLINICAL/PRECLINICAL STUDIES
 PRELINICAL- 1) in-silico (Computer Based
Drug discovery) 2) in-vitro (Cell or Enzyme
based drug discovery) 3) in-vivo ( Animal base
drug discovery)
 CLINICAL STUDIES – IND application is
needed
 Phase 1
 Phase 2
 Phase 3
 After these phase NDA for market then Phase 411

12. CONCEPT OF GENERICS
 A generic drug is a medication created to
be the same as an already marketed
brand-name drug in dosage form, safety,
strength, route of administration, quality,
performance characteristics, and
intended use.
12

13. GENERIC DRUG PRODUCT DEVELOPMENT
 FDA-approved generic medicines work in the
same way and provide the same clinical
benefit and risks as their brand-name
counterparts. A generic medicine is required
to be the same as a brand-name medicine in
dosage, safety, effectiveness, strength,
stability, and quality, as well as in the way it
is taken. Generic medicines also have the
same risks and benefits as their brand-name
counterparts.
13

14. GENERIC DRUG PRODUCT DEVELOPMENT
 FDA requires drug companies to demonstrate that the generic medicine
can be effectively substituted and provide the same clinical benefit as the
brand-name medicine. Generic drug applicants must show the generic
medicine is the same as the brand-name in the following ways:
• The active ingredient in the generic medicine is the same as in the
brand-name drug/innovator drug.
• The generic medicine has the same strength, dosage form (such as a
tablet or an injectable), and route of administration (such as oral or
topical).
• The generic medicine is manufactured under the same strict standards
as the brand-name medicine.
• The label is the same as the brand-name medicine's label (with certain
exceptions).
• The generic medicine is bioequivalent to the brand-name medicine.
14

15. THE APPROVAL PROCESS
 Unlike the approval process for new chemical entities, that for generic drugs allows use of the ANDA,
which does not require the submission of clinical data regarding safety and efficacy since this
information was already provided for the pioneer product. Since the original active ingredient was
already proven safe and effective, the manufacturer must now prove bioequivalence for the
pharmaceutically equivalent generic drug product.
 In order to receive approval for marketing, a generic drug must meet the same batch requirements for
identity, strength, purity, and quality and be therapeutically equivalent to the branded product.
Additionally, the drug must be manufactured according to the same Good Manufacturing Practice
regulations required by the FDA.4 For the generic drug to be therapeutically equivalent, two clinical
characteristics must apply: It must be pharmaceutically equivalent as well as bioequivalent.
Pharmaceutical equivalence means that the active ingredient(s), dose form, route of administration, and
strength are the same for both the branded product and the generic product. Bioequivalence is when
both products have comparable bioavailability when studied under similar conditions
15

16. THANK YOU
16