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Research Methodology: Methods, Approaches and Techniques, 2 Volumes / Mishra, Baidyanath; Satapathy, Ashok Kumar & Mishra, Sujata (Dr.)
Research Methodology: Methods, Approaches and Techniques, 2 Volumes
Mishra, Baidyanath; Satapathy, Ashok Kumar & Mishra, Sujata (Dr.)
List Price : US$ 49.95
Our Price : US$ 39.96

  Book ID : 42989
  ISBN-10 : 81-7637-329-X / 817637329X
  ISBN-13 : 978-81-7637-329-6 / 9788176373296
  Place of Publication : Varanasi
  Year of Publication : 2014
  Edition : (First Edition)
  Language : English
  x+202p., xi+226p., 10 B/W Illus., Figs., Tables, 24 cm. (Jaikrishnadas Ayurveda Series No. 281)


I. Bioethics-Ethical issues in Biology & Technology
1.0. Introduction
1.1. Impact
1.2. Bioethics & Ayurveda
1.3. Other ethical committee

II. Ethical issues in Clinical Research
2.0. Introduction
2.1. Ethical & Safety considerations
2.2. What should be done when an institution does not have IEC
2.3. Format for human ethics approval
2.4. Is human ethical review committee- Human (HERC) required?

III. Product Development Process
3.0. Introduction
3.1. Drug, Nutrients and Nutraceuticals with utrigenomics
3.2. Duration for new product development
3.3. Monitoring authorities of Drug Development
3.4. Steps involved in new product development process
3.5. Ethical issues in product development
3.6. Ethical issues in clinical research
3.7. Terminologies related to product development
3.8. Study of acute, Sub acute and chronic toxicity test

IV. Research & Pharmaco-poeial standards
4.0. Introduction
4.1. Ayurvedic Pharmacopoea Committee
4.2. Quality control in Ayurvedic drugs-ASU
4.3. Important regulatory/legal provisions
4.4. Good manufacturing practices (GMP)
4.5. Good Agricultural & Collection Practices (GACP)

V. Good Clinical Practices (GCP)
5.0. Introduction
5.1. Important definitions
5.2. ASU drugs & GCP
5.3. Principles of ICH-GCP
5.4. Responsibilities of Institutional Review Board (IRB)/Institutional Ethical Committee (IEC)
5.5. Composition & Function of IEC
5.6. Principles of GCP-Global Stand

VI. Essentials & Preparatory before Clinical study
6.0. General information
6.1. Aims & Objectives of the study
6.2. Ethical consideration
6.3. Study Design
6.4. Inclusion, Exclusion and With drawal of subjects
6.5. Assessment of efficacy
6.6. Assessment of safety
6.7. Statistics
6.8. Data Handling and Management
6.9. Quality control and Quality assurance
6.10. Finance and Insurance
6.11. Publication Policy
6.12. Decision of Ethical Committee

VII. Informed Consent
7.0. Introduction
7.1. Process
7.2. Notes and steps during emergency condition
7.3. Compensation of patients/volunteers
7.4. Sample form for the informed consent form

VIII. Clinical Trial Designs
8.0. Introduction
8.1. Approach to Classify Clinical Studies According to Objective
8.2. Importance of clinical trial design
8.3. Types of Clinical designs
8.4. Common Designs
8.5. Special designs for the small scale trials
8.6. Advantages Vs Disadvantages of various designs

IX. Case Record Form (CRF)
9.0. Introduction
9.1. Procedure
9.2. Collection of Participant Data
9.3. Data to be collected on CRF
9.4. Audit trials
9.5. Check list for handling CRFs

X. Randomization and Blinding of Trial
10.0. Introduction
10.1. Need of randomization
10.2. What is meant by randomized clinical trial
10.3. How to randomize
10.4. Methods of Randomization
10.5. Problems and Additional Benefits of Randomization
10.6. Blinding
10.7. Masking & Blinding
10.8. Placebo & Blinding
10.9. Does blinding prevent bias
10.10. What to look for in descriptions of blinding

XI. Phases of Clinical trial
11.0. Introduction
11.1. Discussion & types of clinical trial (Phase-0 to IV)

XII. Drug sources and method of identification
12.0. Introduction
12.1. Discussion on various types of authentication-Herbal, Mineral & Animal origin ingredients with LCMS, HOLC, HPTLC, TLC, AAS etc

XIII. Good Laboratory Practice (GLP)
13.0. Introduction
13.1. Aim of GLP
13.2. Fundamental points of GLP
13.3. OECD-GLP Principles
13.4. GLP inspection check list

XIV. Bio-informatics
14.0. Introduction
14.1. Why Bioinformatics is so important
14.2. Enormity of Genetic Data
14.3. Major Bioinformatics Applications
14.4. Aim of informatics
14.5. Bio-informatics and Ayurveda

XV. Pharmacovigilance
15.0. Introduction
15.1. Why is it import
15.2. Evolution of Pharmacovigilance
15.3. Benefits of Pharmacovigilance
15.4. Responsibilities of Pharrnacovigilance
15.5. Process in Pharmacovigilance
15.6. National Pharmacovigilance Programme for ASU drugs

XVI. Pharmacoeconomics and Pharmacoepidemiology
16.0. Introduction
16.1. Methodological issues in conducting pharmacoeconomicsevaluation
16.2. Types of pharmacoeconomic analysis
16.3. Need of Pharmacoeconomics
16.4. Pharmacoepidemiology & Ayurvedic Pharmacoepidemiology

XVII. Pharmacogenomics
17.0. Introduction
17.1. Pharmacogenomics usefulness
17.2. Pharmacogenomics and Ayurveda

XVIII. RadioBiology
18.0. Introduction
18.1. Radiation effect of cells
18.2. Process of radiation damage
18.3. Direct action of radiation damage
18.4. Indirect action of cell damage
18.5. Fate of irradiated cell
18.6. Repair of Radiation Damage
18.7. Tissue and Organ Sensitivity to Radiation
18.8. Radiation Effects
18.9. Deterministic Effects
18.10. Thresholds for Deterministic Effects-Health hazard
18.11. Stochastic Effects
18.12. High Dose Effects
18.13. Late Effects of High Dose Radiation

XIX. Various in-vivo (animal) & in-vitro models of bioresearch
19.0. Introduction
19.1. Uses of animal model
19.2. History of use of animals in research
19.3. Types of animal model
19.4. In-vitro
19.5. Models of in-vitro

XX. Phamacokinetics and Pharmacodynamics
20.1. Pharmacokinetics
20.2. Pharmacodynamics
20.3. Therapeutic drug monitoring
20.4. Process of Pharmacokinetics
20.5. Models of Pharmacokinetics
20.6. Some terminologies
20.7. Applications of Pharmacokinetics in Ayurveda

XXI. Government organization related to Clinical Research
21.1. Clinical Trial Registry of India (CTRI)
21.2. Central Drugs Standard Control Organization (CDSCO)
21.3. Central Council Of Research In Ayurvedic Sciences (CCRAS)
21.4. Indian Council Of Medical Research (ICMR)

XXII. Intellectual Property Rights (IPR)
22.0. What is Intellectual Property Rights
22.1. Areas of Intellectual Property- Patent, Trade Mark etc
22.2. Types of Intellectual Property- Patent, Trade Mark etc
22.3. Ayurveda and Intellectual Properties Rights 203
22.4. Organizations associated with Intellectual Property Rights

XXIII. Protocols
23.1. Safety & Toxicity profile evaluation of Ayurveda plants and drugs
23.2. Rules No. 170, GSR 893 (E), Drugs & Cosmetic Act (4th Amendment) 2008: Guidelines of evaluation of ASU drugs



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.


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.




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