| 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 |