A ppt on drug design ... most poppulr ppt

2. Contents
Introduction
Drug Discovery
Drug Design
Aims In Drug Design
Important Aspects
 Structure Activity Relationships
 Drug Discovery & Development
FDA Final Review Process:
Conclusion
References

3. Drug development
i.e.
Quality , Safety & Efficacy

4. INTRODUCTION
Drugs play an important role in the health of both
people and the economy of a country.
Pharmaceutical drugs are available from a large
number of sources.
People and Governments willing to spend money on
drugs for many reasons so, it must be safe, effective and
good quality and used appropriately.

5. Drug discovery
Drug discovery is the process through which
potential new medicines are identified.
 It involves a wide range of scientific
disciplines, including biology, chemistry and
pharmacology.

6. Drug Design:
Once the lead compound has been
discovered it can be used as the starting
point for drug design.

7. Drug Design:
There are various aims in drug design:
1.The drug should have a good level of activity for its target
2.The drug should have minimum side effects
3.The drug should be easily synthesized
4.The drug should be chemically stable
5.The drug should have a good selectivity for its target
6.The drug should have acceptable pharmacokinetics properties
7.The drug should be non-toxic

8. Drug Design:
THERE ARE TWO IMPORTANT ASPECTS
Pharmacodynamics properties Pharmacokinetics properties

9. Drug Design:
Structure Activity Relationships
(SAR)
•This involves testing all analogues for biological activity and
comparing them with the original compound.
•If an analogue shows a significant lower activity, then the group that
has been modified must be important.
•If the activity remain similar, then the group is not essential.
•It may be possible to modify some lead compounds directly to the
required analogues and other analogues may be prepared by total
synthesis

10. Drug Discovery & Development
Identify disease
Find a drug effective
against disease protein
(2-5 years)
Preclinical testing
(1-3 years) Human clinical trials
(2-10 years)
FDA approval
(2-3 years)
Isolate protein
involved in
disease (2-5 years)

11. Drug Development Process
Pre Clinical
Testing
Phase I Phase II Phase III FDA Approval
Years 3.5 1 - 2 2 - 4 4 - 6 1.5 Total = 12 - 17
TestPopulation
Laboratory
and Animal
Studies
20 to 100 Healthy
Volunteers
100 – 300 Patient
Volunteers
1,000 to 3,000
Patient Volunteers
Review
Post Marketing
Safety Monitoring
Purpose
Assess
Safety and
Biological
Activity
Determine Safety
and Dosage
Evaluate
Effectiveness. Look
for Side Effects.
Verify Effectiveness,
Monitor Adverse
Reactions from Long-
Term Use
Process
Large Scale
Manufacturing
--------------
Distribution
--------------
Education
%ofall
newdrugs
thatpass
FILEIND
70% of INDs 30% of INDs 27% of INDs
FILENDA
20% of INDs

12. 12

13. 13

15. 15

16. 16
Before marketing a medical device the manufacturer must submit a
premarket notification [510(k)] or a premarket approval (PMA)
application to FDA
•A Premarket Notification [510(k)] is a marketing application
submitted to FDA to demonstrate that the medical device is as
safe and as effective or substantially equivalent to a legally
marketed device. Most devices are cleared for commercial
distribution in the U.S. by the 510(k) process (Class II devices).
•Premarket Approval (PMA) is the process of scientific review by
FDA to evaluate the safety and effectiveness of Class III devices.
Clinical studies in support of a PMA are subject to the
investigational device exemption (IDE) regulations.

17. The development, production, importation,
exportation and subsequent distribution of drugs must
be regulated to ensure that they meet prescribed standards.
 Therefore, effective drug regulation is required to ensure
the safety, efficacy and quality of drugs as well as accuracy
and appropriateness of the drug information available to the
public.

18. References
1.www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf
2.Structure based drug design and molecular modeling. Available
from http://www.imbjena.in
3.Taft, C.A.; Da Silva, V.B.; Da Silva, C.H.T.D. (2008). Current Topics in
Computer-Assisted
4.Drug Design. Journal of Pharmaceutical sciences, Vol. 97, no. 3, pp.
1089-1098.
5.M.E. Wolff (Ed) Medicinal Chemistry and Drug Discovery, John Wiley
& Sons, New York, 5th edn., 1995.

19. Drug Development
i.e.
Quality , Safety & Efficacy
Thank you very
much