1. Stages of drug development
Pharmacology lab
MSc.Ikhlas Jarrar

2. Introduction
Average time to develop new drug is years. On an average out of 10,000 – 30,000 potential substances only 1 could make it to the market. As per 2006 estimates, the cost of bringing a new drug could vary from 500 million to 2,000 million USD.

3. Life Cycle for new drug :

5. Historical Timelines :
Historical Timelines Elixir
sulfanilamide disaster
Thalidomide crisis
1906
1938
No Regulatory control for Drug safety
1961
1937
Federal Food and
Drug Act passed

6. Stages in Drug Development :
Drug Discovery
Pre-Clinical Testing
Phase I Clinical Trials
Phase II Clinical Trials
Phase III Clinical Trials
New Drug Application (NDA) / Biologics License Application (BLA)
Phase IV and Beyond

7. Drug Discovery : Determine the target disease
Determine each component of disease :
Symptoms
Target organ
Biochemical pathways
Search for the target drug : -
Chemically synthesized compound –
Biologically synthesized compound –
Computer simulated compound
Isolate the compound
Proceed to next Stage

8. Pre CLINICAL TRIALS :
Evaluation of acute and short term toxicity in animals. It Involves :
-Lethal dose determination
-Effect of dose at normal level for short/Long term
Assess how the drug is absorbed/distributed/metabolized and excreted in animals.
Proceed to next Stage.

9. 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.

10. Phase 1 CLINICAL TRIALS :
Begins after 30 days of filing IND.
Drug given to healthy volunteers
Duration could vary from 1 month to 1 year.
Following is studied here :
Drug absorption/Metabolism in human.
Effect on organs and tissues. -Side affect of different dosages.
Thus early evidences on effectiveness are achieved.
Proceed to next Stage

11. Phase 2 CLINICAL TRIALS :
Drug given to patient volunteers
Duration could vary from 1 year to 2 years
Cost could vary from $10 - $100 million. Following is studied here : -
Drug effectiveness in treating the disease.
Short term side effects in patients
Less than 1/3rd of INDs survive phase 2
Proceed to next Stage.

12. Phase 3 CLINICAL TRIALS :
FDA consulted before beginning phase 3
Drug given to patient volunteers
Duration could vary from 3 years to 4 years.
Cost could vary from $10 - $500 million
Following is studied here :
Safety of Drug [ Benefits v/s risk analysis ] –
Long term side effects in patients
Proceed to next Stage.

13. 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.

14. 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