Ada POPOLO | CLINICAL TRIAL: EXPERIMENTATION AND MONITORING
Ada POPOLO CLINICAL TRIAL: EXPERIMENTATION AND MONITORING
cod. 0760400048
CLINICAL TRIAL: EXPERIMENTATION AND MONITORING
| 0760400048 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF7 | |
| PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY | |
| 2024/2025 |
| YEAR OF COURSE 5 | |
| YEAR OF DIDACTIC SYSTEM 2023 | |
| SPRING SEMESTER |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| BIO/14 | 6 | 48 | LESSONS |
| Objectives | |
|---|---|
| THE COURSE HAS THE SCOPE TO PROVIDE KNOWLEDGE AND COMPREHENSION OF THE VARIOUS PHASES, METHODOLOGIES AND EXPERIMENTAL APPROACHES TO MONITOR AND EVALUATE THE EFFICACY AND SAFETY OF DRUGS AND MEDICAL DEVICES DURING CLINICAL TRIALS, ACCORDING TO THE ACTUAL REGULATORY LAWS ESPECIALLY REGARDING THE GOOD CLINICAL PRACTICES. ACCORDING TO THE ACQUIRED SKILLS, THE STUDENT WILL HAVE TO BE ABLE TO ANALYZE AND MANAGE THE RESULTS FROM THE CLINICAL TRIAL WITH PARTICULAR ATTENTION TO BE PAID ON THE ABILITY TO PLAN, DESIGN AND STATISTICALLY ANALYZE THE DATA, AS WELL AS TO MANAGE FAULTS RELATED TO THE CLINICAL TRIAL. |
| Prerequisites | |
|---|---|
| FOR UNDERSTANDING OF THIS COURSE, IT IS IMPORTANT THE ACQUISITION OF THE FOLLOWING DISCIPLINES: PHARMACOLOGY AND PHARMACOTHERAPY. |
| Contents | |
|---|---|
| CLINICAL TRIALS. RANDOMISED CONTROLLED CLINICAL TRIALS. ENDPOINTS, EFFICACY MEASURES (8 HOURS). GOOD CLINICAL PRACTICE: INVESTIGATOR, SPONSOR, CONTRACT RESEARCH ORGANISATIONS. ETHICS COMMITTEES, PROTOCOL AND INFORMED CONSENT (10 HRS). STATISTICAL SIGNIFICANCE. DESCRIPTIVE AND INFERENTIAL STATISTICS. SUPERIORITY, EQUIVALENCE AND NON-INFERIORITY STUDIES (6 HOURS). MARKETING AUTHORISATION. NATIONAL PROCEDURE. CENTRALISED AND MUTUAL RECOGNITION PROCEDURES. ROLLING REVIEW (2 HOURS). CLINICAL TRIALS OF MEDICAL DEVICES (4 HOURS). CRITICAL ANALYSIS OF CLINICAL TRIALS. SYSTEMATIC REVIEWS AND META-ANALYSES (4 HOURS). OBSERVATIONAL AND INTERVENTIONAL CLINICAL STUDIES. CASE/CONTROL AND COHORT STUDIES. RELATIVE RISK AND ODDS RATIOS (8 HRS.). PAEDIATRIC CLINICAL TRIALS. ORPHAN DRUGS AND THERAPEUTIC INNOVATION (6 HOURS). |
| Teaching Methods | |
|---|---|
| LECTURE |
| Verification of learning | |
|---|---|
| ORAL EXAMINATION |
| Texts | |
|---|---|
| FARMACOLOGIA GENERALE E MOLECOLARE- CLEMENTI E FUMAGALLI. V EDIZIONE. EDRA FARMACOLOGIA - RANGE E DALE. VIII EDIZIONE. EDRA FARMACOLOGIA - GOVONI E AAVV. II EDIZIONE. CEA TEACHING MATERIAL PROVIDED BY THE TEACHER DURING THE COURSE |
| More Information | |
|---|---|
| ITALIAN TEACHING AT THE DEPARTMENT OF PHARMACY |
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