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Full Description
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.
Contents
Chapter 1: Herbal medicinal trials: Methodologies, regulatory agencies, and future directions. Chapter 2: Introduction to Clinical Trials with special focus on botanicals. Chapter 3: Competitive Landscape Analysis and Market Dynamics of Herbal Medicines. Chapter 4: Integrating Traditional Wisdom and Modern Science: Evidence-Based Approaches and Reverse Pharmacology in Herbal Medicine. Chapter 5: Stakeholders and Their Roles in the Clinical Trials of Herbal Medicines: Navigating Collaboration and Compliance. Chapter 6: Quality Control, Standardization, and Safety Evaluation Strategies of Herbal Medicines for Clinical Trials. Chapter 7: Ethical Aspects of Clinical Trials of Herbal Medicines Across the Globe. Chapter 8: Regulatory Aspects of Clinical Trials of Herbal Medicines in the US. Chapter 9: Regulatory Aspects of Clinical Trials of Herbal Medicines in Non-European Countries. Chapter 10: Good Clinical Practices for Clinical Trials of Herbal Medicine. Chapter 11: Regulatory Aspects, Challenges, and opportunities in Clinical Trials of the Indian System of Medicines. Chapter 12: Latest Advancements in Clinical Trials of Herbal Medicines. Chapter 13: Clinical Trials of Indian System of Medicine based on Case Studies. Chapter 14: Clinical Trials of the Traditional Chinese Medicine (TCM) System Based on Case Studies. Chapter 15: Challenges and future perspectives of herbal medicines. Chapter 16: Future Trends, Emerging Technologies, and Interdisciplinary Collaborations for Clinical Trials of Herbal Drugs.
