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Signal Analysis in Pharmacovigilance. Principles and Processes

ISBN: 9781032629704
ISBN: 9781032629704
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Διαστάσεις 25 × 18 cm
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108,00€(Περιλαμβάνεται ΦΠΑ 6%)

Διαθεσιμότητα: 23-28 ημέρες

Περιγραφή

This book provides detailed concepts and information on principles and processes of signal analysis in pharmacovigilance along with case studies. It covers the fundamental concepts and principles of pharmacovigilance, emphasizing the need for robust signal detection and analysis methods. The book reviews the diverse array of databases and tools employed for signal detection, including electronic health records (EHRs), social media mining, claims data, and distributed data networks. In turn, the book discusses the application of molecular dynamics, molecular docking, and the use of the FDA Adverse Event Reporting System (FAERS) database in signal analysis.

Toward the end, the book explores the identification, validation, and assessment of signals associated with vaccines. This book is useful for graduate, post-graduate students of pharmaceutical sciences, and scientists in pharmacology research and drug development.

Περιεχόμενα

Chapter 1: Introduction to Pharmacovigilance: Ensuring Medication Safety

 

Sachin Kumar and Vikas Maharshi

 

Chapter 2: Drug Safety Signal Detection and management in Pharmacovigilance

 

Mira Desai

 

Chapter 3: Databases and Tools for Signal Detection of Drugs in Post-Marketing Surveillance

Jeesa George, Prizvan Lawrence Dsouza, Yalamanchili Jahnavi, Hemendra Singh, Pramod Kumar A

 

Chapter 4: Role of Electronic medical records, Social Media, Claims data, distributed data networks in signal analysis

 

Vandana Roy

 

Chapter 5: Uncovering False Alarms: Examining Biases and Confounders in Disproportionality Analysis

 

Lipin Lukose, Mansi Pawar, Aina M Shaju, Gouri Nair, Subeesh K Viswam

 

Chapter 6: Role of Medical Coding in Signal Detection

 

Dipika Bansal, Beema T Yoosuf, Muhammed Favas KT

 

Chapter 7: Regulatory Aspects in Signal Detection and Assessment

 

James Buchanan

 

Chapter 8: Disproportionality Methods for Signal Detection in Pharmacovigilance

 

Krishna Undela and Christy Thomas

 

Chapter 9: Bayesian methods of signal detection

 

Dipika Bansal, Muhammed Favas KT, Beema T Yoosuf

 

Chapter 10: Subgroup and sensitivity analysis

 

Faiza Javed and Anoop Kumar

 

Chapter 11: Causality Assessment of ICSRs

 

V. Kalaiselvan and Rishi Kumar

 

Chapter 12: Signal Analysis of Drug-Drug Interaction Using Spontaneous Reporting Method

 

Rima Singh, Ruchika Sharma, Deepti Pandita, Anoop Kumar

 

Chapter 13: Use of network pharmacological approaches in signal analysis

 

Vipin Bhati, Ruchika Sharma, Deepti Pandita, and Anoop Kumar

 

Chapter 14: Docking studies in signal analysis: An overview

 

Kumari Kala Sah, Ruchika sharma, S.latha and Anoop Kumar

 

Chapter 15: Molecular Dynamics simulations in signal validation

 

Debanjan Dey and Anoop Kumar

 

Chapter 16: Identification and validation of novel signal of drugs using FAERS database: A case study

 

Sweta Roy, Vipin Bhati, Ruchika Sharma, Deepti Pandita, and Anoop Kumar

 

Chapter 17: Molecular docking and molecular dynamics in Signal analysis: A case study

 

Sweta Roy, Ruchika Sharma, and Anoop Kumar

 

Chapter 18: Available Databases and Tools for signal detection of vaccines

 

Sachin Kumar and Vikas Maharshi

 

Chapter 19: Identification and validation of signals associated with vaccines

 

Juny Sebastian

 

Chapter 20: Neurological and behaviour alterations with COVID-19 vaccines using Vaccine Adverse Event Reporting System (VAERS): A Retrospective study

 

Amir, Saquib Haider and Anoop Kumar

 

Chapter 21: Pharmacovigilance based drug repurposing via inverse signals

 

Simran Ohra and Anoop Kumar

 

Chapter 22: Prospective role of preclinical experimentation in validating the safety signals

 

Chandragouda Raosaheb Patil, Chandrakant Gawli and Shwetank Bhat

 

Chapter 23: Role of Artificial Intelligence in Signal Detection

 

Rethesh Kiran, Priyanka, Jeesa George, Pramod Kumar A, Prizvan Lawrence Dsouza