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S.No. Category Code Title
1 ICH Guidelines-Efficacy E11 Step 4 CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION
2 ICH Guidelines-Efficacy E10 Step 4 CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS
3 ICH Guidelines-Efficacy E9 Step 4 STATISTICAL PRINCIPLES FOR CLINICAL TRIALS
4 ICH Guidelines-Efficacy E8 Step 4 GENERAL CONSIDERATIONS FOR CLINICAL TRIALS
5 ICH Guidelines-Efficacy E7 Step 4 STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS
6 ICH Guidelines-Efficacy Questions & Answers E7 Studies in Support of Special Populations: Geriatrics
7 ICH Guidelines-Efficacy E6(R1) Step 4 GUIDELINE FOR GOOD CLINICAL PRACTICE
8 ICH Guidelines-Efficacy E5(R1) Step 4 ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA
9 ICH Guidelines-Efficacy Questions & Answers E5 Implementation Working Group
10 ICH Guidelines-Efficacy E4 Step 4 DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION
11 ICH Guidelines-Efficacy E3 Step 4 STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS
12 ICH Guidelines-Efficacy E2F Step 4 DEVELOPMENT SAFETY UPDATE REPORT
13 ICH Guidelines-Efficacy CH E2F EXAMPLE DSUR – PHASE III INVESTIGATIONAL DRUG-MODEL DSUR – Non-Commercial Sponsor-Vasculogenesis Growth Factor-2 (VGF-2)-Development Safety Update Report #2
14 ICH Guidelines-Efficacy ICH E2F Step 4 EXAMPLE DSUR – PHASE III INVESTIGATIONAL DRUG ZB3579
15 ICH Guidelines-Efficacy E2E Step 4 PHARMACOVIGILANCE PLANNING
16 ICH Guidelines-Efficacy E2D step 4 POST-APPROVAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
17 ICH Guidelines-Efficacy E2C(R1) Step 4 CLINICAL SAFETY DATA MANAGEMENT: PERIODIC SAFETY UPDATE REPORTS FOR MARKETED DRUGS
18 ICH Guidelines-Efficacy E2B(R2) Step 4 MAINTENANCE OF THE ICH GUIDELINE ON CLINICAL SAFETY DATA MANAGEMENT : DATA ELEMENTS FOR TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS
19 ICH Guidelines-Efficacy E2A Step 4 CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
20 ICH Guidelines-Efficacy E1 Step 4 THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY FOR DRUGS INTENDED FOR LONG-TERM TREATMENT OF NON-LIFE-THREATENING CONDITIONS
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  (From: 21-06-2012)
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