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Pharmacovigilance Essentials de Mukesh Nandave

Pharmacovigilance Essentials

Editat de Mukesh Nandave, Anoop Kumar
en Limba Engleză Hardback – 4 apr 2024

Structura volumului Pharmacovigilance Essentials, coordonat de Mukesh Nandave și Anoop Kumar, este riguros organizată pentru a acoperi întregul spectru al siguranței medicamentului, de la fundamentele istorice până la provocările tehnologice actuale. Remarcăm progresia logică a materialului: primele capitole stabilesc cadrul teoretic și procesarea reacțiilor adverse (ADR), urmate de o analiză comparativă a sistemelor de reglementare din UE, SUA și regiunile non-UE. Apreciem în mod deosebit includerea unor nișe critice, precum capitolul 12 dedicat herbovigilenței și capitolul 13 axat pe materiovigilență, domenii care primesc adesea o atenție secundară în manualele standard.

Această ediție 2024 se poziționează pe linia clinică a lucrării Medicines Safety and Pharmacovigilance de Rabia Hussain, dar cu un accent pregnant pe integrarea noilor tehnologii. În timp ce titluri precum Mann's Pharmacovigilance oferă o perspectivă enciclopedică, Pharmacovigilance Essentials se distinge prin actualitatea informațiilor privind rolul inteligenței artificiale și al farmacogeneticii în evaluarea riscurilor. Experiența de lectură este una densă, clinică, facilitată de o segmentare clară a bazelor de date globale și a metodelor de detectare a semnalelor.

Editorul Mukesh Nandave aduce în acest volum expertiza sa vastă în farmacologie, vizibilă și în lucrări anterioare precum Ethnopharmacology and OMICS Advances in Medicinal Plants Volume 2. Dacă în operele precedente s-a concentrat pe mecanismele moleculare și compoziția chimică, aici coordonează o sinteză sistemică despre modul în care aceste substanțe sunt monitorizate post-marketing pentru siguranța pacientului.

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Specificații

ISBN-13: 9789819989485
ISBN-10: 9819989485
Pagini: 508
Ilustrații: XIX, 486 p. 1 illus.
Dimensiuni: 160 x 241 x 31 mm
Greutate: 1.01 kg
Ediția:2024
Editura: Springer
Locul publicării:Singapore, Singapore

De ce să citești această carte

Recomandăm această lucrare profesioniștilor din domeniul farmaceutic și autorităților de reglementare care au nevoie de o resursă actualizată pentru 2024. Cititorul câștigă o perspectivă globală asupra sistemelor de raportare și, esențial, înțelege cum inteligența artificială și farmacogenetica transformă detecția semnalelor de siguranță. Este un instrument indispensabil pentru implementarea sistemelor de farmacovigilență conform standardelor internaționale actuale.

Despre autor

Editorul Mukesh Nandave este un cercetător recunoscut în domeniul farmacologiei, cu o expertiză ce variază de la studiul plantelor medicinale la farmacologia cardiovasculară. Printre lucrările sale notabile se numără Ethnopharmacology and OMICS Advances in Medicinal Plants Volume 2, unde explorează mecanismele genetice ale plantelor, și Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors in Heart Failure, axat pe terapii moderne pentru diabet și boli cardiovasculare. În volumul de față, Mukesh Nandave își folosește experiența vastă pentru a sintetiza protocoalele complexe de siguranță necesare în practica medicală și farmaceutică contemporană.

Cuprins

Chapter 1_ Introduction to Pharmacovigilance.- Chapter 2_ History of Pharmacovigilance and Regulatory Actions.- Chapter 3_ Databases Used in Pharmacovigilance Across the Globe.- Chapter 4_ Processing of ADRs.- Chapter 5_ Signal Detection and Aggregate Reporting.- Chapter 6_ Reporting of ADRs across the globe.- Chapter 7_ Pharmacovigilance System in India. - Chapter 8_ Pharmacovigilance System in EU.- Chapter 9_ Pharmacovigilance System in USA.- Chapter 10_ Pharmacovigilance System in non-EU Countries.- Chapter 11_ Vaccine Safety Surveillance.- Chapter 12_ Herbovigilance.- Chapter 13_ Materiovigilance.- Chapter 14_ Hemovigilance.- Chapter 15_ Role of Pharmacogenetics in Pharmacovigilance.- Chapter 16_ Signal Detection and Assessment in Pharmacovigilance.- Chapter 17_ Role of Artificial Intelligence in Pharmacovigilance.- Chapter 18_ Current Challenges and Future Perspectives.

Notă biografică

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.
Dr. Anoop Kumar currently working as an Assistant Professor in the Department of Pharmacology, Delhi Pharmaceutical Sciences & Research University (DPSRU), Govt. of NCT of Delhi, New Delhi, India. Earlier, he worked as an Assistant Professor and Head in the Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, and as an officiating Head and Associate Professor in the Department of Pharmacology, ISF College of Pharmacy, Moga, Punjab. He has also worked as a research scientist in the medical affairs and clinical research department of sun pharmaceutical industries limited, Gurugram, and Translational Health Science Institute (THSTI), Faridabad. He has completed his Ph.D. from Birla Institute of Technology, Mesra, Ranchi as a DST INSPIRE Fellow. He has also served as an expert member of the Board of Studies (BOS) of the Clinical Research Programme of IKGPTU, Jalandhar, Punjab (2019-2021) and Drug Discovery Hackathon 2020 joint initiative of AICTE, CSIR, and Govt. of India. 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.

Textul de pe ultima copertă

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 a comprehensive guide for healthcare professionals, researchers, regulators, and policymakers involved in pharmacovigilance.

Caracteristici

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

Descriere

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The book explores the field of pharmacovigilance, its historical context, along with its critical role in ensuring the safety of medications across the world.