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 |