1. Drug Development Process Stages involved in Regulating Drugs
Clinical Trials
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2. Clinical Trials - IND Phase 1
Initial Introduction into Human (20-100
Healthy volunteers)
Dose Ranging
determined the maximum-tolerated dose with potential toxicities well-defined
Closely Monitoring
Safety
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3. IND Phase 2 Controlled Clinical Trials Effectiveness (Preliminary)
Defines the dose regimen of the drug
Closely Monitoring
Relatively Small Numbers (
Patient volunteers)
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4. IND Phase 2 (Cont’) End-of-Phase 2 Meeting
Package received 30 days before scheduled date
Outstanding Nonclinical/CMC issues
Proposed Phase 3 adequate and well-controlled study design and analysis plan
Obtain agreement from FDA on Phase 3 adequate (מספיק)and well-controlled study design and analysis plan
Adequate and well-controlled study
Has agreed-upon adequate and well-controlled design
Provides the data the FDA will base its go/no-go decision on
Must meet high scientific standards: controlled, blinded, randomized, adequate size
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5. IND Phase 3
Verifying efficacy, establishing safety, and establishing the optimum dosage
Larger Studies ( Patient volunteers)
Controlled
Pivotal :((הכרעהTo provide the data sufficient to convince the FDA of the favorable benefit / risk ratio of the drug under investigation
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6. Drug Development Process Stages involved in Regulating Drugs
Basic Disciplines of Drug Development
Clinical Trials
Preclinical Testing
File IND at FDA
Phase I
Phase II
Phase III
File NDA at FDA
FDA
Phase IV
Years
3.5
1 - 2
2 - 4
4 - 6
1.5
Total
12 –17
Additional Post marketing testing required by FDA
Test Population
Laboratory and animal studies
20 to 100 healthy volunteers
100 to 300 patient volunteers
1000 to 3000 patient volunteers
Review process / Approval
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
Success Rate (%)
70 of IND’S
30 of IND’S
27 of IND’S
20 of IND’S
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7. Role of Laboratories in Medicine
Medical Testing Laboratory
patient care
clinical drug trial
Research Laboratory
discovery & development of new
drugs/therapy
fundamental research/mechanisms of diseases
Manufacturing
post clinical trials, bulk
drugs, cell-based therapy, plasma products, medical
device
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8. REFERANCE
Good Laboratory Practice by Ainoon Othman Department of Pathology Faculty of Medicine, UKM
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