Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

The book has three parts. The first discusses the special properties of herbal medicines that need to be considered when designing research protocols.

Author: World Health Organization. Regional Office for the Western Pacific

Publisher: World Health Organization

ISBN: 9290611103

Category: Medical

Page: 86

View: 650

Sets out detailed guidelines for conducting scientific research on the safety and efficacy of herbal medicines. The guidelines which reflect the consensus reached by 17 experts in pharmacology biochemistry and traditional medicine respond to the need to assure the safety of widely-used herbal medicines while also facilitating the search for new pharmaceutical products. Specific research criteria are covered together with general principles of investigation including ethical concerns. The book has three parts. The first discusses the special properties of herbal medicines that need to be considered when designing research protocols. The second part provides detailed guidance on the objectives of research the contents of a research protocol and the methods of investigation for non-clinical studies and for Phase I to Phase IV clinical trials. The third part which forms the core of the book presents three sets of research guidelines: for quality specifications of plant materials and preparations for pharmacodynamic and general pharmacological studies of herbal medicines and for toxicity investigation of herbal medicines. Topics covered range from the information required to establish the identity and quality of plant materials or preparations through the selection of appropriate test systems for pharmacodynamic studies to detailed advice on the many different tests examinations observations and experimental procedures required in experimental animals and controls to establish the safety of herbal medicines. The guidelines are intended to facilitate the work of research scientists and clinicians while also furnishing some reference points for the governmental industrial and non-profit organizations providing financial support.
Categories: Medical

Traditional Herbal Medicine Research Methods

Traditional Herbal Medicine Research Methods

According to the definition in Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines of the World Health Organization (WHO), issued in 1994, herbal medicine is a plant-derived material or preparation with ...

Author: Willow J.H. Liu

Publisher: John Wiley & Sons

ISBN: 9780470922668

Category: Science

Page: 448

View: 234

This book introduces the methodology for collection and identification of herbal materials, extraction and isolation of compounds from herbs, in vitro bioassay, in vivo animal test, toxicology, and clinical trials of herbal research. To fully understand and make the best use of herbal medicines requires the close combination of chemistry, biochemistry, biology, pharmacology, and clinical science. Although there are many books about traditional medicines research, they mostly focus on either chemical or pharmacological study results of certain plants. This book, however, covers the systematic study and analysis of herbal medicines in general – including chemical isolation and identification, bioassay and mechanism study, pharmacological experiment, and quality control of the raw plant material and end products.
Categories: Science

International Cooperation Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation  Convergence and Harmonization of Pharmaceutical Regulations

Supported by several WHA and Executive Board resolutions, WHO has developed and issued a series of technical guidelines (e.g., guidelines for the assessment of herbal medicines, research guidelines for evaluating the safety and efficacy ...

Author: Pierre-Louis Lezotre

Publisher: Academic Press

ISBN: 9780128005699

Category: Medical

Page: 376

View: 242

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area
Categories: Medical

Drug Discovery Development

Drug Discovery   Development

2 Upto several Seven Evaluate hundreds months to effectiveness , further year safety evaluation 3 Several 1-4 years ... researched should follow WHO's Research guidelines for evaluating the safety and efficacy of herbal medicines .

Author: Bhushan Patwardhan

Publisher: New India Publishing

ISBN: 8189422294

Category: Medical

Page: 368

View: 718

While biotechnological advances, genomics and high throughput screenings or combinatorial and asymmetric syntheses are opening new opportunities in drug discovery, the industry is facing serious innovation deficit. The total number of new molecules registered per year has dropped in contrast to expected increase. Post marketing failures of blockbuster drugs have become major concerns of industries. On the other side, globally there is a major shift to sue of traditional medicine involving complementary and alternative therapies. Ethnopharmacology and traditional medicines have contributed in past significantly in the process of natural product drug discovery. There are two clear tracks where ethnopharmacology has potential to contribute in future drug research. First, as a discovery engine to provide new targets, leads, and second, use of quality assured and standardized traditional medicines. In this scenario, it is important to understand the mechanisms of drug discovery and pharmaceutical development with a focus on herbal drugs and neutraceutical. This book provides historical perspective, future prospects and significance of ethnopharmacology in drug research. It also provides important steps in botanical drug discovery and development including bioprospecting, quality control, standardization, pharmaceutics, stability, pharmacokinetics, and bioavailability with examples from ethnopharmacology and herbal medicine. One of the important feature of this book is to give an excellent insight to Good Laboratory and Good Clinical Practices along with very useful summary steps involved in filing IND or NDA of botanical products. The book also gives Regulators' perspective of validating claims and how ethnopharmacological or traditional medicines need different approach.
Categories: Medical

Essentials of Herbal Drug Technology

Essentials of Herbal Drug Technology

RESEARCH. GUIDELINES. FOR. EVALUATING. THE. SAFETY. AND. EFFICACY. OF. HERBAL. MEDICINES. Herbs are the mines of useful drugs have been used in traditional medical systems, for thousands of years and have made a great contribution to ...

Author: Shanti Bhushan Mishra

Publisher: Educreation Publishing


Category: Education

Page: 318

View: 583

Essentials of Herbal Drug Technology is a unique attempt to arouse the inteDr. Shanti Bhushan Mishra is serving as Associate Professor at United Institute of Pharmacy, Allahabad where he has been since 2010. He received his degree of Bachelor of Science (B.Sc.) from Lucknow University, Lucknow and Bachelor of Pharmacy (B. Pharm.) from Bundelkhand University Jhansi, India. Gold Medalist in Post-graduation (M. Pharm.) from Vinayaka Mission University Salem, Tamilnadu and PhD from Sam Higginbottom Institute of Agriculture, Technology & Sciences (SHIATS), Allahabad. Major contribution has been in the field of Diabetes especially engaged in investigating on natural antioxidant from botanical sources and their role in diabetes management. Presently he is holding the positions of consultant editor of International Journal of Pharmaceutical Sciences and Research, Journal of Pharmaceutical & Biomedical research and International Journal of Therapeutic Application. He has selected as nominee of CPCSEA (Committee for the purpose of control and supervision of experiments on animals) under ministry of environment, forest and climate change government of India. He has published 50 research papers in national and international journals of repute. He has presented 28 papers in various national and international conferences as invited speaker and resource person. He has four books and three book chapters in his credit. He is lifetime member of Association of Pharmaceutical Teachers of India, Indian Science Congress Association Kolkata, Societa Italo-Latino Americana de Etnomedicina, Costa Rica and American Chemical Society of students in this fast-developing branch of pharmacy i.e. Pharmacognosy and related fields like herbal medicine, natural products and their standardization because increasing interest in the field of herbal medicine and ayurvedic dosage forms; their standardization is utmost required. The Book provides in depth information about various guidelines of different regulatory bodies that are required in quality control of herbal drugs. This book has been written with the object that the new syllabus of the bachelor’s in pharmacy, master’s in pharmacy and doctorate in herbal medicines and their pharmacological efficacy as per PCI course curriculum is covered in reasonable detail to provide sound scientific knowledge of quality control and standardization.
Categories: Education

Traditional and Complementary Medicine

Traditional and Complementary Medicine

Since 1991, WHO has developed and issued a series of technical guidelines such as guidelines for the assessment of herbal medicines, research guidelines for evaluating the safety and efficacy of herbal medicines, and guidelines for ...

Author: Cengiz Mordeniz

Publisher: BoD – Books on Demand

ISBN: 9781789841831

Category: Science

Page: 112

View: 207

Modern medicine has reached a point where the patient is not treated as a biopsychosocial-spiritual being but rather is seen as a virtual identity consisting of laboratory findings and images. More focus is placed on relieving the symptoms instead of curing the disease. Mostly, patients are turned into lifetime medication-dependent individuals. New medicines are needed to overcome the side effects, complications, resistance, and intolerance caused by pharmacological and interventional therapies. In hopes of drug-free and painless alternative treatments with fewer complications, there has been a trend to revisit traditional methods that have been dismissed by modern medicine. Traditional medicine has to be reevaluated with modern scientific methods to complement and integrate with evidence-based modern medicine.
Categories: Science

Some Traditional Herbal Medicines Some Mycotoxins Naphthalene and Styrene

Some Traditional Herbal Medicines  Some Mycotoxins  Naphthalene and Styrene

IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, International Agency for Research on Cancer ... 3, 447–452 WHO (1993) Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, Manila WHO ...

Author: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans

Publisher: World Health Organization

ISBN: 9789283212829

Category: Medical

Page: 602

View: 517

This publication represents the views and expert opinions of an IARC Working Group which met in Lyon, 12-19 February 2002.
Categories: Medical

Botanical Dietary Supplements

Botanical Dietary Supplements

In : Botanical Medicine - Efficacy , Quality Assurance and Regulation . ... In : Economic and Medicinal Plant Research . Vol . ... Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines , Manila , World Health ...

Author: Gail B. Mahady

Publisher: CRC Press

ISBN: 9026518552

Category: Science

Page: 288

View: 995

This volume provides reviews and details of the quality, safety and efficacy for some of the top-selling botanicals worldwide, including black cohosh, chamomile, comfrey, echinacea, garlic, ginkgo, ginseng, kava, milk thistle, St John's wort and valerian. The work was written based on a systematic review of the scientific literature from 1975-2000.;Each review includes a brief introduction, a section on quality including a definition of the crude drug, geographical distribution, and a listing of the major chemical constituents. The safety and efficacy sections summarize the medical uses, pharmacology, contraindications, warnings, precautions, adverse reactions, dose and dosage forms. The safety and efficacy sections were written for a busy health-care professional, and should enable one to ascertain which clinical uses are supported by clinical data, without having to read through all the pharmacology. Each chapter is fully referenced, enabling the reader to access further information when necessary.
Categories: Science

Toxicological Survey of African Medicinal Plants

Toxicological Survey of African Medicinal Plants

6.3.3 WHO Recommendations for Subchronic and Chronic Toxicity Study The research guidelines for evaluating the safety ... Research guidelines for evaluating the safety and efficacy of herbal medicines [81] are discussed below: G Animal ...

Author: Victor Kuete

Publisher: Elsevier

ISBN: 9780128004753

Category: Medical

Page: 744

View: 201

Toxicological Survey of African Medicinal Plants provides a detailed overview of toxicological studies relating to traditionally used medicinal plants in Africa, with special emphasis on the methodologies and tools used for data collection and interpretation. The book considers the physical parameters of these plants and their effect upon various areas of the body and human health, including chapters dedicated to genotoxicity, hepatotoxicity, nephrotoxicity, cardiotoxicity, neurotoxicity, and specific organs and systems. Following this discussion of the effects of medicinal plants is a critical review of the guidelines and methods in use for toxicological research as well as the state of toxicology studies in Africa. With up-to-date research provided by a team of experts, Toxicological Survey of African Medicinal Plants is an invaluable resource for researchers and students involved in pharmacology, toxicology, phytochemistry, medicine, pharmacognosy, and pharmaceutical biology. Offers a critical review of the methods used in toxicological survey of medicinal plants Provides up-to-date toxicological data on African medicinal plants and families Serves as a resource tool for students and scientists in the various areas of toxicology
Categories: Medical

Healthcare Policies And Systems In Europe And China Comparisons And Synergies

Healthcare Policies And Systems In Europe And China  Comparisons And Synergies

Traditional and Modern Medicine: Harmonizing the Two Approaches, 2000. Guidelines for Clinical Research on Acupuncture, 1995. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, 1993. Clinical Evaluation of ...

Author: Mucelli Attilio

Publisher: World Scientific

ISBN: 9789813231238

Category: Health & Fitness

Page: 516

View: 625

Healthcare Policies and Systems in Europe and China, a product of an interdisciplinary European Union-funded project, comprehensively investigates opportunities for mutual integration in the healthcare sector of the two regions and analyses policies at both national and local levels, the legal environment, medical practices, as well as the state of respective healthcare industries and related businesses. The book sheds light on both the potential benefits and obstacles to the integration of Chinese and Western medicine, as well as practices and industries in Europe and China. An interdisciplinary approach is adopted throughout using tools and technical knowledge derived from the economics, social sciences, legal and medical fields. This edited volume seeks to provide guidelines and policy proposals for policy-makers both in Europe and China, as well as offer operational suggestions for companies working in or with China, to enhance bilateral trade and investment flows. It also presents medical evidence and economic/legal analysis that will help boost the integration of traditional Chinese medicine with Western medicine through research studies. This is a recommended read for graduates, researchers and policy-makers seeking for a holistic understanding of healthcare policies and systems, both in theory and in practice. Contents: Healthcare System and Industry in Europe and China: Common Issues and Future Opportunities: Relevance of Western Medicine and TCM in the Chinese and European Markets: An Overview (Attilio Mucelli) New Horizons of Chinese Healthcare System: Reforms and Perspectives (Daniela Caruso) Effect of Aging on Healthcare Industry's Cooperation Opportunities Between Europe and China (Dan Yang, Qinhong Wu and Attilio Mucelli) The Chinese TCM Industry: Growth, Changes and Policies (Marco R Di Tommaso, Manli Huang, Yue Qi and Chiara Pollio) Trade in Medical Products Between China and EU (Qu Ruxiao, Zeng Yanping and Liu Xia) The Healthcare Industry in the Chinese Economy: Insights from Input–Output Analysis (Noemi Ferracuti, Claudio Socci and Francesca Spigarelli) European Healthcare Industry and Chinese FDI: Where Do Chinese Firms Invest? (Ping Lv, Yu Liang and Francesca Spigarelli) Monopoly in the Chinese Healthcare Market: Norms and Practices (Lihong Zhang and Changmian Zhang) The Chinese Private Hospital Sector and FDI: From Socialization to Opening Up (Federica Monti) Investments, Research, Education, and TCM (Paolo Sospiro) The Integration of Western and Traditional Chinese Medicine: Challenges and Opportunities: Assessing Costs, Benefits, and Cost-Effectiveness in TCM (Attilio Mucelli and Olena Liakh) Evaluating the Use of TCM Through the Theory of Planned Behaviour: A Consumer Survey Analysis (Olena Liakh) Legal Framework on Health Foods in China and Food Supplements in the EU: A Comparison Study in the Perspective of TCM (Pamela Lattanzi and Qingle Hu) The Balance Between Patients' Choice and Economic Constraint in the Use of TCM Therapies: Two European Cases (Erik Longo and Laura Vagni) Understanding Traditional Chinese Medicine from a Legal and Semantic Perspective (Saisai Wang and Kim Van der Borght) Female Doctors in Ancient China: Comparative Studies Through Literature and Science (Elena Santilli) Traditional Chinese Medicine: Evidences from the Medical Field: Using International Perspective to Develop Traditional Chinese Medicine (Xiaolin Yuan and Xu Zhang) Cancer-Related Digestive Symptoms (Qijun Fang, Yujuan Wang and Tianshu Xu) Cancer-Related Fatigue (Qijun Fang, Yuj
Categories: Health & Fitness