This book comprehensively provides the research and validation of herbal medicines within modern clinical trials. The book covers the basics of herbal remedies, their historical and cultural contexts, and delves into specific methodologies such as traditional evidence-based medicine, reverse pharmacology, and integrative medicine. It examines pharmacokinetics and pharmacodynamics, herb-drug interactions, and outlines the roles of various stakeholders in herbal medicine trials. Detailed attention is given to quality control, standardization, and safety evaluation, alongside methods for conducting randomized clinical trials. Ethical and regulatory challenges are addressed extensively, with separate focus on regulations in the US, EU, and non-EU countries, including specific challenges in the Indian system of medicines. The text also highlights the use of artificial intelligence and machine learning in clinical trials, presents recent advancements, best practices, and the future trends in herbal medicine research.

Key Features:

· Provides a thorough overview of herbal medicines, detailing their historical and cultural backgrounds alongside modern scientific research

· Explores specific research methodologies like traditional evidence-based medicine, reverse pharmacology, and integrative medicine approaches tailored to herbal medicines

· Includes in-depth examinations of how herbal medicines interact within the body and with other drugs

· Emphasizes the importance of standardization, quality control, and safety evaluation strategies in conducting clinical trials for herbal medicines

· Discusses ethical and regulatory challenges, with specific sections on regulations in the U.S., EU, non-EU countries

This book is an essential resource for regulatory professionals, researchers, and clinicians seeking to bridge traditional herbal practices with rigorous scientific research.

Anoop Kumar currently working as an Assistant Professor in the Department of Pharmacology, Delhi Institute of Pharmaceutical Education and Research (DIPSAR), Delhi Pharmaceutical Sciences & Research University (DPSRU), Govt of NCT of Delhi. Recently, he has also been included in top 2% list of scientists released by Stanford. Earlier, he worked as an Assistant Professor in the Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, and as a Head and Associate Professor in the Department of Pharmacology, ISF College of Pharmacy, Moga, Punjab. He has also worked as Research Scientists in the Medical Affairs and Clinical Research Department of Sun Pharmaceutical Industries Limited, Gurugram, and Translational Health Science Institute (THSTI), Faridabad. He has also worked as an expert in Drug Discovery Hackathon 2020 joint initiative of AICTE, CSIR, and Govt. of India. He has also received various fellowships like GATE, UGC BSR, and DST INSPIRE.

He has authored more than 120 research and review articles and 30 book chapters in the International Journal and publishers of repute. He has also edited 05 International books of reputed publishers like Elsevier, Springer, Taylor and Francis. He is also an Associate editors and editorial board members of various International Journals of Elsevier, Wiley, and Springer Nature. He has also delivered more than 50 expert talks in International and National Conferences. He has also worked as Member Secretary of the Institutional Animal Ethics Committee (IAEC) and Animal House In-charge. Currently, he is working as member secretary of human ethics committee approved by CDSCO and Treasurer of ISPOR India Chapter. His lab also gets funding from DST SERB SRG and CRG, ICMR, National Innovation Foundation (NIF)-India, and IIT-Delhi. His research interests are in the following areas: 1) Drug repurposing 2) Meta-analysis of clinical trials 3) Network Pharmacology 4) Pharmacoeconomic studies 5) Signal analysis in Pharmacovigilance 6) Animal experimental studies

Devesh Tewari currently serving as Assistant Professor in the Department of Pharmacognosy and Phytochemistry, and In-charge UPLC facility at DPSRU, New Delhi. He also served as Visiting Scientist to the Institute of Genetics and Animal Biotechnology of the prestigious Polish Academy of Sciences, Poland. He is amongst Youngest Pharmacognosy teachers in the world featured in the list of “World Ranking of Top 2% Scientists” by Stanford University & Elsevier from last 4 years including carrier wise list. He is a renowned researcher in the field of natural product drug discovery and formulation development with main focus in exploration of medicinal plants of the Himalayan region through Ethnopharmacology. Dr Devesh is a leading expert in the field of natural products drug discovery. In addition, he also served in the high level committees formed to clinically validate some natural products based drugs derived from grassroots innovations/ethnopharmacology. Having significant research achievements in the field of pharmacological validation and phytochemistry of western Himalayan plants. He received several important awards for plant drug research like Young Scientist Award by UCOST, Govt. of Uttarakhand, Best Paper Award by Ministry of AYUSH, Govt. of India, Best Concept Note Award by PCI, Govt. of India, Research Appreciation Award for 3 consecutive years from LPU, First, Second and Third Prize for Presentation of Research work including Monetary Awards for research and Hindi Writing. He is also a Member of the Pharmacopoeia Committee (PCIM&H), expert member for specific publications related to COVID-19 of Ministry of AYUSH and expert reviewer for grant proposals of international research councils. Dr Devesh is having various research grants from DST, Government of India. Resource person/Expert and Presenting Author in prestigious international and national conferences, Editorial Board Member for some prestigious journals. Researcher profile: h-index: 45; i10-index: 106 and citations: >900