About the Author

Dr. Baidyanath Mishra completed B.A.M.S as a topper in the university examination from Govt. Ay Medical College & Hospital Balangir Orissa affiliated to Sambalpur University. Later he completed M.D (Ay) from one of the premier institutes of education and research i,e Institute of P.G Ayu Education and Research affiliated to University of Calcutta, and now under West Bengal University of Health Sciences. Presently, he is pursuing his Ph.D (Ay) in the Faculty of Health Sciences at SCSVMB (Kanchi University) at Kanchipuram. Dr. Mishra has contributed more than two decades to teaching and research, including of PG teaching. He successfully guided more than ten students of M.D (Ay) of Sharir Rachana (Anatomy). Presently he is working as Professor & HoD of Sharir Rachana (Anatomy) at Adichunchanagiri Shikshana Trust's'" Sri Kalabyraveswara Swamy Ay Medical College Hospital & Research Centre (SKAMC) Bangalore. Prior to that he was working as Professor in PG Department of Alva's Ayu Medical College Hospital Moodbidri, SJS Ay Medical College Nazarathpettai, Chennai unit of SCSVMB (Kanchi University), and Dhanwanatari Ay Medical College Research centre Siddapura. He has been invited as a resource person for various national & international conferences in India & abroad on key issues on natural products. Apart from hi teaching, he has contributed in research projects associated with other organizations of repute in research & delivery. Presently he is a board member with Bharati Dashan University, Trichy for the M.Sc (Biodiversity) apart from closely associated with various leading organization that includes of recent includes Inno Vision Therapeutics, INC USA, and Inno Vision HealthCare India on various research projects from natural sources delivering patentable deliverable forms.

Foreword

There is no doubt that traditional medicinal system of medicines including Ayurveda, Siddha, and Unani (ASU) plays a crucial in healthcare in India. Even the worldwide interest in the use of natural products and plant-based remedies had led to different situations developing in different countries. In countries with a strong foundation of traditional medicine such as India and China, nationally recognized parallel traditional systems have run for long periods, along with Western medicine with varying degrees of acceptance, integration and assimilation.

That is resulting in developing and manufacturing quality of ASU stands very crucial and is the mantra of the safe and effective therapy. Government of India brings various regulatory guidelines with an aim to provide in the best of the consumers, and continuously advise and train the technical people in working out a vast range of drugs for human & animal use and have evolved in developing the research, documentation and involving sophistication in the production of medicaments.

Accordingly, department of AYUSH has brought forward the detailed guidelines of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and regularly amend the related portion of Drugs & Cosmetics Act to create general awareness among the persons who are involved in this professions or who are keen in this profession was long felt.

It is this backdrop that the present book titled 'Comprehensive text book on research methodology with clinical research methods, approaches & techniques' penned by learned Dr. Baidyanath Mishra who is working as professor with a tremendous knowledge on techno- scientific and regulatory inserts of global regulatory on herbals/botanicals, is a desired addition which is by virtue of its meaningful inclusion is bound to go a long way in clearing to the void, which is in operations as of now.

Dr. Mishra along with other supporting authors has diligently and articulately attempted to cover all the aspects of research including special topics on clinical research, domestic regulatory critical points etc in bringing awareness starting from the graduates of Ayurveda.

I am sure that this notable attempt will result in fulfilling the legitimate needs and expectations of the researchers and quality aware-scavy students starting from the study in undergraduate.

I record my gratitude and appreciation to the author for his herculean effort in dispensing a gigantic task.

Preface

Research is a lifelong passion. It is driven by a restless curiosity that is refined by meticulous attention to the minutest details. Research necessitates high self-esteem, advanced skills, robust knowledge and humility. The last quality bespeaks of the fact that science is a collective global enterprise. All this requires years of apprenticeship and training. We are in requirement of more number of people with dual competences in both Ayurveda and basic sciences taking this traditional healthcare facility through scope of research globally. Without such a critical mass, it is unrealistic to expect high quality research.

Ayurveda, the ancient Indian medical wisdom prescribed numerous ways and means to overcome the chronic and incurable diseases and associated medical, psychological and social problems in a holistic way including various metabolic, respiratory, reproductive, digestive, dermatological, musculoskeletal, cardiovascular disorders including cancer.

World Health Organization (WHO) including Government of India along with various key International regulatory organizations enlisted key points in establishing various traditional medicinal systems including of Ayurveda to document the safety, efficacy and purity of the products and practices through the approved research protocols. ASU medicines are governed by rules and regulations prescribed by Drugs & Cosmetic Act] 940 and Rules 1945, whereas herbal nutraceutical products are governed by rules & regulations of Food Safety Standards and Authority of India (FSSAI) Act 2006 and rules 2011. Those design special guidelines which are updated periodically in developing various formulations for India, and these products follow respective guidelines based on the country of export.

The main sources of inspiration to bring out this book have been my continued interaction with students, faculty and practitioners of health sciences including Ayurveda engaged in public health services at various institutions in India and abroad.

This book consists of twenty two chapters and are arranged in descent manner that suits the reading and comprehensive skill of the reader. This book covers variety of topics such as identification and prioritization of research problems that includes bio-ethics, ethical issues in clinical research, product development process, pharmacopoeal standards of ASU ingredients, critical points of good clinical practice, good laboratory and Manufacturing practices including ICH & AYUSH standards, bio-informatics, PKPD, Radiobiology, Pharmacoeconomics etc. which are of time requirement.

Students will find this book is helpful for them with a clear and concise overview of the important topics in which they must become proficient to practice skillfully, ethically and efficiently which are equally cover their recommended study curriculum.

I am thankful with Chaukhamba Orientalia making this mission successful extending my thought process in globalizing Ayurveda through research across all Ayurveda teaching institutes in India and abroad by publishing this book.

I am equally thankful to express my heartfelt appreciation with Mrs. Sujata Mishra-senior faculty in psychology and Mr. Ashok Kumar Satapathy who is a learned faculty in physical sciences contributing their expertise in various related chapters, thus making this book more elaborative.

Hope that it will fulfill the felt needs of not only post-graduate students, but also the young teaching faculty in healthcare profession. However looking forward suggestions from the readers are always welcome so as to enable to incorporate the same in future editions to make this book more reader compatible.

INDEX