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Pharmacovigilance: A Practical Approach

Pharmacovigilance: A Practical Approach

Autorzy
Wydawnictwo Elsevier - Health Sciences Division
Data wydania 01/08/2018
Liczba stron 228
Forma publikacji książka w miękkiej oprawie
Poziom zaawansowania Dla profesjonalistów, specjalistów i badaczy naukowych
ISBN 9780323581165
Kategorie Farmakologia
455.00 PLN (z VAT)
$123.76 / €101.46 / £87.16 /
Produkt na zamówienie
Dostawa 14 dni
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Opis książki

Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance. Covers the evolving regulatory landscape, as well as current and future use of digital technologies. Uses case studies to ensure content is relevant to everyday practice. Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance. Consolidates today's available information on this timely topic into one convenient resource.

Pharmacovigilance: A Practical Approach

Spis treści

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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