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DRUG DISCOVERY
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1
TABLE OF CONTENT
S.N TITLE PAGE
O
1 OVERVIEW OF NEW DRUG 4-11
DEVELOPMENT
Historically, drugs were discovered through identifying the active ingredient from
traditional remedies.
Once a compound that fulfills all of these requirements has been identified, it will
begin the process of drug development prior to clinical trials.
The drug discovery requires expensive Phase I, II and III clinical trials, and most
of them fail. Small companies have a critical resources to run the clinical trials.
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 4
DRUG DEVELOPMENT
Pre-Clinical
Process R&D
Pharmacology Chem Eng. R&D
Safety Assessment Manufacturing
Toxicology
Drug Metabolism
(ADME)
Pharmaceutical R&D
Formulation Bio Process R&D
Clinical Investigator
& patient
Regulatory Affairs
Clinical Pharmacology Project Planning & Management
Clinical Research Marketing
Molecular level
Cellular Level
Organismal level
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 9
4) LEAD DISCOVERY
1 2 3 4 5 6 7 8 9 10
2.The investigators and the sponsoring party then prepare the study
protocol (study plan) and other relevant documents for submission to an
Institutional Review Board (IRB) for approval.
2. Prevention trials
Tests for better ways to prevent a disease
3. Diagnostic trials
To find better tests to identify a disease
4. Screening trials
To find better ways to detect a disease or health condition
1 2 3
6 5
8
Dr.K.Saminathan.M.Pharm(Ph.D) , M.B.A (Ph.D) 16
EXAMPLE OF CLINICAL TRIAL CONDUCTION