1st Edition
Signal Analysis in Pharmacovigilance Principles and Processes
This book provides detailed concept 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. Towards 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.
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
Biography
Dr. Anoop Kumar is currently working as Assistant Professor in Department of Pharmacology, Delhi Pharmaceutical Sciences & Research University (DPSRU), Govt. of NCT of Delhi, New Delhi, India. He has earlier served as Assistant Professor in the Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPER), Raebareli. He has also worked as Associate Professor and Head in the Department of Pharmacology, ISF College of Pharmacy, Moga, Punjab. He has also worked as Research Scientist in Translational Health Science Institute (THSTI), Faridabad and Medical Affairs and Clinical Research Department of Sun Pharmaceutical Limited, Gurugram, India.
He has authored more than 100 research and review articles as well as 20 book chapters in International Journals and Publishers of repute. His current h-index is 25, i10 index 53 with citations of 2132. He is also an author of 03 books. He has also filed 05 Indian patents. He has received research grants from the Indian Government (DST SERB, ICMR, and IIT Delhi). He was receipt of DST INSPIRE Fellow (2012-2016), as well as receipt of Distinguished and Notable Researcher Award (2021-2022). He has also been included in the top 2% lists of scientists released by Stanford. Currently, he is also working as member secretary of human ethics committee approved by Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare, Government of India and Treasure of International Society for Pharmacoeconomics and Outcomes Research (ISPOR) India Chapter. He is also an expert member in Board of studies of various reputed Universities. He is life time members of various professional societies like Indian Pharmacological Society (IPS), Association of Pharmaceutical Teachers of India (APTI), and Society for Alternatives to Animal Experiments (SAAE), India. He has also worked as member secretary and animal house In charge approved by Committee for Control and Supervision of Experiments on Animals (CCSEA), Government of India. His research interests are drug repurposing using computational and experimental studies, Meta-analysis, Signal analysis in Pharmacovigilance, Pharmacoeconomic studies.
