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Stages of drug
development
Introduction
Average time to develop new drug is
10 -12 years. On an average out of
10,000 30,000 potential substances
only 1 could make it to the market. As
per 2010 estimates, the cost of
bringing a new drug could vary from
500 million to 2,000 million USD.
Historical
Timelines
sulfanilamide disaster
1906
No Regulatory
control for Drug
safety
1937
Thalidomide crisis
1938
1961
Lessons Learned
As a result of the sulphanilamide and thalidomide
tragedy, the following lessons were learned:
Pharmaceutical products should be
systematically tested for developmental effects
prior to marketing.
There are differences in species sensitivity and
manifestations of developmental toxicity.
Use of a second species or more thoroughgoing
interpretation of results in a single species
(taking pharmacokinetics into consideration) are
important considerations in drug testing.
Pharmacodynamics
(PD): (effects on
organs or systems)
-- Evaluation or quantification
of what the body does to a
drug substance over time
-- Evaluation or
quantification of what the
drug substance does to
the body over time, and
over drug concentrations
Drug Discovery
Symptoms
Target organ
Biochemical pathways
Chemically synthesized compound
Biologically synthesized compound
Computer simulated compound
Drug Discovery
Drug Discovery
IND program
It is the means by which a pharmaceutical
company obtains permission to ship an
experimental drug across state lines
(usually to clinical investigators) before a
marketing application for the drug has been
approved.
The FDA reviews the IND application for
safety to assure that research subjects will
not be subjected to unreasonable risk.
If the application is approved, the candidate
drug usually enters a Phase 1 clinical trial.
Drug Discovery
Drug Discovery
Drug Discovery
Drug Discovery
NDA
NDA Refers to New Drug Application
Formal proposal for the FDA to approve a
new drug for sale in the U.S.
Sufficient evidences provided to FDA to
establish:
Drug is safe and effective.
Benefits outweigh the risks.
Proposed labeling is appropriate.
Drug Discovery
Market Launch/Phase 4 :
launched to the Market
Additional post marketing testing of
patients to
Support the use of the approved indication
Finding new therapeutic opportunities
Extending use of the drug to different classes
of patients like children