clinical research and pharmacovigilance book pdf free download

A Textbook of Clinical Research and Pharmacovigilance PDF

This book describes all concepts, practices, methods and regulatory guidelines related to clinical research, clinical trials and pharmacovigilance in a simple, lucid and easily understandable manner and covers the entire syllabus prescribed by Pharmacy Council of India (PCI), New Delhi for Pharm.D and M. Pharm courses.             The book provides a comprehensive knowledge of various aspects such as drug development and approval process, pharmacological and toxicological approaches and methods, pharmaceutical dosage form approaches for drug development, clinical approaches and clinical trials, phases, types, designs and statistical tests of clinical trials, regulatory aspects, GCP as per ICH, WHO, ICMR, Schedule Y and regulatory environment in US, Europe and India in 20 chapters. Special emphasis is given to Pharmacovigilance methods and Pharmacovigilance programme of India (PvPI).             The book provides a comprehensive knowledge of all aspects of clinical research, clinical trials, GCP guidelines and Pharmacovigilance as per the requirements of clinical research industry and personnel. The subject is presented in a simple, lucid and easily underst...

Chapter List (27 chapters):

• Chapter 1: Cover
• Chapter 2: Halftitle
• Chapter 3: Title
• Chapter 4: Copyright
• Chapter 5: Preface
• Chapter 6: Foreword
• Chapter 7: Contents
• Chapter 8: Drug Discovery, Development and Approval Process: An Overview
• Chapter 9: Approaches to Drug Discovery (Pharmacological and Toxicological)
• Chapter 10: Drug Characterization, Preformulation and Dosage Form Development
• Chapter 11: The Investigational New Drug (IND)Application and New Drug Application (NDA)
• Chapter 12: Clinical Development of Drugs -Introduction and Evolution of Clinical Research
• Chapter 13: Clinical Research Methodology (Phases, Types, Designs and Statistical Concepts of Clinical Trials
• Chapter 14: Clinical Trials Research in India(Clinical Trial Phases, Process, Documentation and Regulations)
• Chapter 15: Methods of Post Marketing Surveillance (PMS)
• Chapter 16: Abbreviated New Drug Application (ANDA) Submissions
• Chapter 17: Guidelines and Principles of Good Clinical Practices (ICH & WHO)
• Chapter 18: Comparison of Clinical Trial Regulations in India, Europe and USA
• Chapter 19: Challenges in the Implementation of GCP Guidelines
• Chapter 20: Ethical Guidelines in Clinical Research
• Chapter 21: Composition, Role and Responsibilities of Institutional Ethics Committee (IEC) in Clinical Trials
• Chapter 22: Regulatory Environment in US, India and Europe
• Chapter 23: Role and Responsibilities of Clinical Trial Personnel as per GCP
• Chapter 24: Designing of Clinical Study Documents and Informed Consent Process
• Chapter 25: Data Management in Clinical Research
• Chapter 26: Safety Monitoring in Clinical Trials
• Chapter 27: Pharmacovigilance

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Pharmacovigilance Books Free Download

Download Pharmacovigilance Books PDF For Free. In this post of MyPharmaGuide , we have shared Free Books For the subject of Pharmacovigilance. All these books going to be extremely helpful for your studies. So Download them for free and start learning. Pharmacovigilance is the science and activity which is related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problems.

Table of Contents

A Practical Guides On Pharmacovigilance For Beginners

Contents of this book are:

• Standard Terms & Definitions in Pharmacovigilance
• Global perspective of Pharmacovigilance
• Domestic perspective of Pharmacovigilance
• Guidelines and laws governing Pharmacovigilance
• Global Adverse Event Reporting systems and Reporting forms
• Individual Case Safety Reports
• Periodic Safety Update Reports
• Answers for Case studies
• Answers for Exercise based Questions
• Pharmacovigilance

• Introduction
• Legal Basis – EU
• Legal Basis – United States
• Ethical Oversight, Consent and Confidentiality
• Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation
• Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials
• Mechanisms of Adverse Drug Reactions
• Micturin and Torsades de Pointes
• Withdrawal of Terodiline: A Tale of Two Toxicities
• Nomifensine and Haemolytic Anaemia
• WHO Programme – Global Monitoring
• Medical Dictionary for Regulatory Activities (MedDRA®)
• Regulatory Pharmacovigilance in the EU
• Spontaneous Reporting – UK
• Spontaneous Reporting – France
• Spontaneous Reporting in Germany
• Spontaneous Reporting – United States
• Statistical Methods of Signal Detection
• Statistical Methods of Evaluating Pharmacovigilance Data
• Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
• Pharmacovigilance in the Netherlands
• CIOMS Working Groups and their Contribution to Pharmacovigilance
• PEM in the UK
• PEM in New Zealand
• MEMO in the United Kingdom
• The General Practice Research Database: Now and the Future
• Overview of North American Databases
• Other Databases in Europe for the Analytic Evaluation of Drug Effects
• Surveillance for Medical Devices – USA
• Pharmacovigilance and Risk Management in Japan
• Dermatological ADRs
• Gastrointestinal ADRs
• Haematological ADRs
• Hepatic ADRs
• Ocular Side Effects of Prescription Medications
• Drug Safety in Pregnancy
• Renal Adverse Drug Reactions
• Anaesthetic Adverse Drug Reactions.
• Pharmacovigilance in Pediatrics
• The Cardiovascular Spectrum of Adverse Drug Reactions
• Drugs and the Elderly
• US Activities in Risk Management of Pharmaceutical Products
• Risk Management – a European Regulatory View
• The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents
• Pharmacoepidemiology of Hormone Therapy: An Evolving Picture
• NSAIDs – COX-2 Inhibitors – Risks and Benefits
• Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences
• Teaching and Learning Pharmacovigilance
• Practical Experience in Teaching Pharmacovigilance
• Fatal Medication Errors and Adverse Drug Reactions – Coroners’ Inquests and Other Sources
• Pharmacogenetics and the Genetic Basis of ADRs
• Keynote Clinical Lessons from Pharmacovigilance

A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines

The contents of this book are:

• Pharmacovigilance centre
• Passive pharmacovigilance
• Active pharmacovigilance
• Minimum reporting requirements
• How to report
• Where to report
• What to report
• When to report
• Who should report
• Sharing the results
• ntroduction
• Epidemiology
• First step – Implementation
• Second step – establishing the cohort(s)
• Third step – acquiring the data The medicines
• Database for CEM
• Maximizing the reporting rate
• General advice and information
• Fourth step – Clinical review
• Quality control
• Coding of medicines and diseases
• Using CemFlow
• Collating and summarizing the events
• Serious events
• Pregnancies
• Lactation exposure
• Lack of efficacy
• Late onset reactions
• Concomitant morbid conditions
• Relationship/Causality assessment
• Signal identification
• Strengthening the signal
• Identifying risk factors
• Differences between spontaneous reporting and CEM
• Organization
• Communication

MindMaps of Pharmacovigilance Basics

• Introduction to Drug Development Process
• History of Pharmacovigilance
• Reporting of Adverse Reactions and Adverse Events
• Post Marketting Survellance
• Casuality Assessment
• Signal Management Process
• Risk Management Plan
• Short Notes

Pharmacovigilance Nirali

• Introduction to Pharmacovigilance
• Introduction to Adverse Drug Reactions
• Basic Terminologies Used in Pharmacovigilance
• Drug and Disease Classification
• Drug Dictionaries and Coding in Pharmacovigilance
• Establisihing Pharmacovigilance Programme
• Vaccine and Safety Survellance
• Pharmacovigilance Method
• Communication in Pharmacovigilance
• Statistical MEthods for Evaluating Medication Safety Data Data Generation
• ICH Guidelines for Pharmacovigilance
• Pharmacogenomics of Adverse Drug Reaction, Drug Safety Evaluation in special population
• CDSO (India) and Pharmacovigilance

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A Textbook of Clinical Research and Pharmacovigilance

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Pharmacovigilance Essentials

Advances, Challenges and Global Perspectives

• © 2024
• Mukesh Nandave 0 ,
• Anoop Kumar 1

Department of Pharmacology, Delhi Pharmaceutical Sciences and Research University, New Delhi, India

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• Delves into pharmacovigilance fundamentals, history, databases, ADR processing, and signal detection
• Explains pharmacovigilance systems in India, EU, USA, non-EU countries, ensuring global perspective
• Explores emerging fields like vaccine safety, herbovigilance, materiovigilance, hemovigilance, AI integration

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About this book

The book explores the field of pharmacovigilance, its historical context, along with its critical role in ensuring the safety of medications across the world. From its foundational principles to cutting-edge advancements and future challenges, this book provides a thorough understanding of the field's intricacies. The book begins by establishing the fundamentals of pharmacovigilance, emphasizing its significance in monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) that occur during the use of medications. Delving into the history of pharmacovigilance and regulatory actions, the book traces the evolution of the field, highlighting significant milestones and the establishment of regulatory frameworks that govern medication safety. It explores the pivotal role of regulatory authorities in developing guidelines, regulations, and policies to safeguard public health. A significant aspect covered in the book is the processing of ADRs, providing insights into the steps involved in handling and evaluating ADR reports.  The book also addresses specialized areas within pharmacovigilance, including vaccine safety surveillance, herbovigilance (monitoring the safety of herbal medicines), materiovigilance (monitoring the safety of medical devices), and hemovigilance (ensuring the safety of blood products). Additionally, the book explores the role of pharmacogenetics in pharmacovigilance, highlighting how genetic factors influence individual responses to medications and how this knowledge can be integrated into safety monitoring and risk assessment. This book also covers databases used in pharmacovigilance across the globe, aggregate reporting and pharmacovigilance systems in EU and non-EU countries, and the role of artificial intelligence.

Finally, it emphasizes the need for continuous improvement, vigilance, and proactive measures to adapt to the changing healthcare landscape and address emerging safety concerns. The book serves as acomprehensive guide for healthcare professionals, researchers, regulators, and policymakers involved in pharmacovigilance.

• Signal Detection
• Vaccine Safety
• Regulatory Actions
• Drug Evaluation
• Safety Monitoring
• Drug Discovery
• Evidence-Based Medicine
• Adverse Drug Reactions (ADRs)

Table of contents (18 chapters)

Front matter, introduction to pharmacovigilance.

• Surbhi Soni, Mukesh Nandave, Anoop Kumar

History of Pharmacovigilance

• Muntaha Javid, Mukesh Nandave, Anoop Kumar

Databases Used in Pharmacovigilance Across the Globe

• Vipin Bhati, Mukesh Nandave, Anoop Kumar, Deepti Pandita

Processing of ADRs

• Sweta Roy, Mukesh Nandave, Anoop Kumar

Aggregate Reporting

• Rima Singh, Mukesh Nandave, Anoop Kumar, Deepti Pandita

Reporting of ADRs Across the Globe: India, USA, EU, and Non-EU

• Priyanka Sharma, Mukesh Nandave, Anoop Kumar

Pharmacovigilance System in India

• Megha Sahu, Mukesh Nandave, Anoop Kumar

Pharmacovigilance System in EU

• Deepali Siwan, Mukesh Nandave, Anoop Kumar

Pharmacovigilance System in the USA

• Deepika Pandey, Mukesh Nandave, Anoop Kumar

Pharmacovigilance System in Non-EU Countries

• Divya Shukla, Mukesh Nandave, Anoop Kumar, Deepali Siwan

Vaccine Safety Surveillance

• Mohd Amir, Mukesh Nandave, Anoop Kumar

Herbovigilance

• Prabhakar Kumar, Mukesh Nandave, Anoop Kumar, Dipali Nandave

Materiovigilance

• Maneesh Soni, Mukesh Nandave, Anoop Kumar

Haemovigilance

• Mohammad Hamid, Mukesh Nandave, Anoop Kumar

Role of Pharmacogenetics in Pharmacovigilance

• Ruchika Sharma, Mukesh Nandave, Anoop Kumar

Introduction to Signal Detection in Pharmacovigilance

Role of artificial intelligence in pharmacovigilance.

• Jyoti Upadhyay, Mukesh Nandave, Anoop Kumar

Current Challenges and Future Perspectives: Pharmacovigilance

• Alishan Zia, Mukesh Nandave, Anoop Kumar

Back Matter

Editors and affiliations.

Mukesh Nandave, Anoop Kumar

About the editors

Dr. Mukesh Nandave is an associate dean (research & development) and head of the Department of Pharmacology and pharmaceutical biotechnology at Delhi Pharmaceutical Sciences and Research University, Govt. of NCT of Delhi, New Delhi, India. He has earlier served as associate professor and head of the department of pharmacology at NMIMS University, Mumbai (2010-2017). He has also worked as a research scientist in the medical affairs and clinical research department of Ranbaxy Research Laboratories (currently known as Sun Pharmaceutical Industries Limited, Gurugram). Dr. Nandave earned his Ph. D. in pharmacology from AIIMS, Delhi and received his post-doctoral training from the Ohio State University Medical Center, Coohio, lumbus, USA.

For more than 20 years, Dr. Nandave has investigated the role of nutraceuticals, herbomineral formulations, and phytoconstituents for myocardial ischemia & reperfusion injury, diabetes, obesity, and pain management. He has published numerous papers in peer-reviewed national and international journals and various book chapters. His lab received more than 3.5 crore total funding from Govt. (DBT, DST, ICMR and AYUSH) as well as industry (Pharmazz, Dabur, Charak, Madhavbaug, Sandu).

Dr. Nandave has received numerous awards. He is secretary-general of the International Academy of Cardiovascular Sciences (IACS)-India section and treasurer of the Society for Promotion and Research of Cardiovascular Sciences (SPARCS). He is a life member of various professional bodies, including the International Society for Heart Research (ISHR), the International Academy of Cardiovascular Sciences (IACS), the Indian Pharmacological Society (IPS), the Indian Pharmaceutical Association (IPA), the Association of Physiologist and Pharmacologist of India (APPI); Association of Pharmaceutical Teachers of India (APTI), and Society for Ethnopharmacology.

He has authored many research and review articles and a few book chapters in the International Journal and publishers of repute. He has also worked as member secretary of the Institutional Animal Ethics Committee (IAEC) and Animal House In-charge. Recently, he has also been included in top 2% list of scientists released by Stanford. His lab also gets funding from DST SERB SRG (30 lakhs), ICMR Mission Project (1.3 crores), and IIT-Delhi (10 lakhs). Dr. Anoop Kumar is Member Secretary of Institutional ethics Committee for Clinical trials and BA/BE studies at DPSRU and Treasurer of ISPOR India Chapter.

Bibliographic Information

Book Title : Pharmacovigilance Essentials

Book Subtitle : Advances, Challenges and Global Perspectives

Editors : Mukesh Nandave, Anoop Kumar

DOI : https://doi.org/10.1007/978-981-99-8949-2

Publisher : Springer Singapore

eBook Packages : Medicine , Medicine (R0)

Copyright Information : The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2024

Hardcover ISBN : 978-981-99-8948-5 Published: 04 April 2024

Softcover ISBN : 978-981-99-8951-5 Due: 18 April 2025

eBook ISBN : 978-981-99-8949-2 Published: 03 April 2024

Edition Number : 1

Number of Pages : XIX, 486

Number of Illustrations : 1 b/w illustrations

Topics : Pharmacology/Toxicology , Biomedicine, general , Drug Safety and Pharmacovigilance , Medicine/Public Health, general , Pharmacy , Public Health

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