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## Meet the editors

Dr. Charmy S. Kothari has more than 14 years of teaching and research experience. She has 35 research papers and review articles published in reputed Indian and International journals. She received several awards for the best oral and poster presentation and recipient of National Dr. P. D. Sethi's Award for a research paper. She is a recognized Post Graduate and Ph.D. Guide at the Institute of Pharmacy, Nirma University. To date, she has been a

guide for 6 PhD and 35 M.Pharm students. She has received research grants from government funding agencies such as GUJCOST and ICMR. She received the DST-SERB International Travel Grant for attending an international conference AOAC in Canada. Her research areas of interest are stability studies, impurity profiling and isolation, identification and characterization, and the world-wide pharmacovigilance system.

Mr. Manan Shah (B.Pharm, M.S. Forensic Pharmacy (Gold Medalist)) is currently pursuing his Ph.D. at the Institute of Pharmacy, Nirma University in the field of pharmacovigilance. Manan Shah is an active member of the International Society of Pharmacovigilance (ISOP) and has attended an international conference and workshop organized by ISOP. He has presented a paper on Pharmacovigilance in an international conference at

Geneva, Switzerland. He previously worked as Assistant at the Astra Lifecare Pvt. Ltd. in the Regulatory Affairs Department. He has also worked as a Junior Research Associate at Veeda Clinical Research based at Ahmedabad. His areas of interest are Pharmacovigilance and PSUR.

Ms. Rajvi Patel (Pharm.D) has teaching experience of more than two years and is currently engaged at the faculty at Nirma University, Institute of Pharmacy. She is currently guiding M.Pharm students in Regulatory Affairs. She also has prior experience in clinical research and the training department at Cliantha Research Limited where she was involved in training employees in various regulatory aspects. She has also worked as a registered

pharmacist for two years at Basinger's Pharmacy, Illinois. She has actively participated in workshops such as medical writing and conferences such as Nipicon, 54th Indian Pharmaceutical Congress and Indian Pharmacognosy Society and ISPRA. She has presented a poster entitled "Drug abuse trends among pharmacists" during her tenure as pharmacist in USA.

**Preface III**

Basics of Pharmacovigilance **1**

**Chapter 1 3**

**Chapter 2 17**

**Chapter 3 45**

**Chapter 4 61**

*by Marta Vázquez, Pietro Fagiolino, Cecilia Maldonado, Natalia Guevara,* 

**Section 1**

Contents

Monitor Drug Safety

*and Carlos Azambuja*

Introductory Chapter: Pharmacovigilance

Pharmacovigilance in Pediatric Population

Insight into Phenytoin Behaviour

*by Charmy S. Kothari, Manan P. Shah and Rajvi M. Patel*

Evolving Roles of Spontaneous Reporting Systems to Assess and

*by Emanuel Raschi, Ugo Moretti, Francesco Salvo, Antoine Pariente, Ippazio Cosimo Antonazzo, Fabrizio De Ponti and Elisabetta Poluzzi*

*by Roxana De Las Salas and Claudia Margarita Vásquez Soto*

*Manuel Ibarra, Isabel Rega, Adriana Gómez, Antonella Carozzi* 

Active Pharmacovigilance in Epileptic Patients: A Deep

## Contents


Preface

The book "Pharmacovigilance" describes the pathway to understand that pharmacovigilance plays a specialized and pivotal role in ensuring ongoing safety of medicinal products. Written in plain English, the book is concise, jargon-free, facilitates an understanding of the fundamentals of pharmacovigilance, and

Consuming a drug is equivalent to consuming a risk. It is only when the benefit associated with the drug is more than the risk, that the consumption of a drug is justified. Thus, it is the benefit versus risk ratio of the drug that decides whether a drug is to be taken or not. The next question is how to measure risks and how to measure benefits. Due to individualization of drugs to patients, it is the clinical judgment of the physician to identify what will benefit the observations related to Pharmacovigilance. The studies related to Pharmacovigilance indicate the possible

Pharmacovigilance is an emerging area for employment in recent years. Information and in-depth knowledge of drugs is an advantage for anybody who wants to make career in this field. Hence, pharmacists are well suited to exploit the opportunity. The job potential is both local as well as global. Opportunities are enormous, one

Authors have tried to make the contents of the book more informative and inclusive; however, for an ever-changing field such as Pharmacovigilance, updates are probably a daily affair. Authors have attempted to make the content inclusive;

**Charmy Kothari**

Ahmedabad

**Manan Shah**

**Rajvi Manthan Patel**

India

India

Institute of Pharmacy, Nirma University,

Institute of Pharmacy, Nirma University,

Institute of Pharmacy, Nirma University,

explores regulatory aspects involved in pharmacovigilance.

risks associated with the drug.

however, comments are welcome.

only has to make a commitment for the career.
