Description

Book Synopsis


Table of Contents
Introduction 1. Does Regulation Drive Science or Does Science Drive Regulation? 2. Role of Epidemiology in Pharmaceutical Industry 3. Real World Epidemiologic Studies and Patient Registries Section III. Benefit-Risk in the Drug Development Life Cycle 4. Signal Management and Methods of Signal Detection 5. Causality Assessment and Examples of Adverse Drug Reactions (Drug Induced Liver Injury, Skin, Major Adverse Cardiac Events and Renal) 6. Product Safety Monitoring in Clinical Trials 7. Benefit-Risk Assessments 8. Communicating benefit risk 9. Pharmacovigilance and Medical Devices 10. Vaccine Safety Surveillance 11. Pharmacovigilance in Special Populations (Pediatrics and Elderly) 12. Pharmacovigilance in Pregnancy 13. Impact and Implications of Technology on Pharmacovigilance 14. The Future of Pharmacovigilance

Pharmacovigilance A Practical Approach

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    Order before 4pm tomorrow for delivery by Sat 13 Jun 2026.

    A Paperback by Thao Doan, Linda Scarazzini, Cheryl Renz

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      View other formats and editions of Pharmacovigilance A Practical Approach by Thao Doan

      Publisher: Elsevier Health Sciences
      Publication Date: 8/2/2018 12:00:00 AM
      ISBN13: 9780323581165, 978-0323581165
      ISBN10: 0323581161

      Description

      Book Synopsis


      Table of Contents
      Introduction 1. Does Regulation Drive Science or Does Science Drive Regulation? 2. Role of Epidemiology in Pharmaceutical Industry 3. Real World Epidemiologic Studies and Patient Registries Section III. Benefit-Risk in the Drug Development Life Cycle 4. Signal Management and Methods of Signal Detection 5. Causality Assessment and Examples of Adverse Drug Reactions (Drug Induced Liver Injury, Skin, Major Adverse Cardiac Events and Renal) 6. Product Safety Monitoring in Clinical Trials 7. Benefit-Risk Assessments 8. Communicating benefit risk 9. Pharmacovigilance and Medical Devices 10. Vaccine Safety Surveillance 11. Pharmacovigilance in Special Populations (Pediatrics and Elderly) 12. Pharmacovigilance in Pregnancy 13. Impact and Implications of Technology on Pharmacovigilance 14. The Future of Pharmacovigilance

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