Pharmacovigilance: A Practical Approach

Häftad, Engelska, 2018

Av Thao Doan, Linda Scarazzini, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, MD Doan, Thao, USA) Scarazzini, Linda, MD (Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, United States) Renz, Cheryl (Senior Medical Director, Safety Science, Pharmacovigilance and Patient Safety, AbbVie, North Chicago, Illinois, PhD H.C. Lievano, Fabio, MD, Chicago. IL) Bhattacharya, Mondira, MD (Head, Benefit-Risk Management, Innovative Platforms Initiative & Epidemiology, Pharmacovigilance and Patient Safety, AbbVie Inc.

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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.

Produktinformation

Utgivningsdatum2018-08-02
Mått191 x 235 x 16 mm
Vikt480 g
FormatHäftad
SpråkEngelska
Antal sidor228
FörlagElsevier Health Sciences
ISBN9780323581165

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Farmakologi inom Medicin

Thao Doan is Group Medical Director, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Department of Pharmacology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA Linda Scarazzini is Senior Vice President, Pharmacovigilance and Patient Safety, Epidemiology and R&D Quality Assurance, Chief Safety Officer, AbbVie, North Chicago, IL, United States. Fabio Lievano isVice President, Patient Safety, Scientific Collaborations, and New Business Advancement, Pharmacovigilance and Patient Safety, Epidemiology and, R&D Quality Assurance, AbbVie, North Chicago, IL, United States; Adjunct Faculty, Loyola University Stritch School of Medicine, Maywood, IL, United States; Adjunct Faculty, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.

Introduction1. Does Regulation Drive Science or Does Science Drive Regulation?2. Role of Epidemiology in Pharmaceutical Industry3. Real World Epidemiologic Studies and Patient RegistriesSection III. Benefit-Risk in the Drug Development Life Cycle4. Signal Management and Methods of Signal Detection5. 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 Trials7. Benefit-Risk Assessments8. Communicating benefit risk9. Pharmacovigilance and Medical Devices 10. Vaccine Safety Surveillance11. Pharmacovigilance in Special Populations (Pediatrics and Elderly)12. Pharmacovigilance in Pregnancy13. Impact and Implications of Technology on Pharmacovigilance14. The Future of Pharmacovigilance