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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

 

S.N.

Chapter Page

 

Chapter-I

Bioethics-Ethical issues in Biology & Technology

 

1.0

Introduction

1

1.1

Impact

1

1.2

Bioethics & Ayurveda

2

1.3

Other ethical committee

3

Chapter-II

Ethical issues in Clinical Research

 

2.0

Introduction

4

2.1

Ethical & Safety considerations

4

2.2

What should be done when an institution does not have IEC

6

2.3

Format for human ethics approval

11

2.4

Is human ethical review committee- Human (HERC) required?

13

Chapter-III

Product Development Process

 

3.0

Introduction

15

3.1

Drug, Nutrients and Nutraceuticals with utrigenomics

15

3.2

Duration for new product development

17

3.3

Monitoring authorities of Drug Development

17

3.4

Steps involved in new product development process

18

3.5

Ethical issues in product development

19

3.6

Ethical issues in clinical research

20

3.7

Terminologies related to product development

22

3.8

Study of acute, Sub acute and chronic toxicity test

25

Chapter-IV

Research & Pharmaco-poeial standards

 

4.0

Introduction

29

4.1

Ayurvedic Pharmacopoea Committee

29

4.2

Quality control in Ayurvedic drugs-ASU

32

4.3

Important regulatory/legal provisions

33

4.4

Good manufacturing practices (GMP)

34

4.5

Good Agricultural & Collection Practices (GACP)

42

Chapter- V

Good Clinical Practices (GCP)

 

5.0

Introduction

43

5.1

Important definitions

43

5.2

ASU drugs & GCP

50

5.3

Principles of ICH-GCP

50

5.4

Responsibilities of Institutional Review Board (IRB)/Institutional Ethical Committee (IEC)

51

5.5

Composition & Function of IEC

52

5.6

Principles of GCP-Global Stand

54

Chapter- VI

Essentials & Preparatory before Clinical study

 

6.0

General information

56

6.1

Aims & Objectives of the study

56

6.2

Ethical consideration

57

6.3

Study Design

57

6.4

Inclusion, Exclusion and With drawal of subjects

58

6.5

Assessment of efficacy

58

6.6

Assessment of safety

58

6.7

Statistics

58

6.8

Data Handling and Management

59

6.9

Quality control and Quality assurance

59

6.10

Finance and Insurance

59

6.11

Publication Policy

60

6.12

Decision of Ethical Committee

61

Chapter- VII

Informed Consent

 

7.0

Introduction

62

7.1

Process

63

7.2

Notes and steps during emergency condition

66

7.3

Compensation of patients/volunteers

66

7.4

Sample form for the informed consent form

67

Chapter- VIII

Clinical Trial Designs

 

8.0

Introduction

77

8.1

Approach to Classify Clinical Studies According to Objective

78

8.2

Importance of clinical trial design

79

8.3

Types of Clinical designs

81

8.4

Common Designs

84

8.5

Special designs for the small scale trials

85

8.6

Advantages Vs Disadvantages of various designs

87

Chapter-IX

Case Record Form (CRF)

 

9.0

Introduction

90

9.1

Procedure

91

9.2

Collection of Participant Data

91

9.3

Data to be collected on CRF

92

9.4

Audit trials

92

9.5

Check list for handling CRFs

92

Chapter-X

Randomization and Blinding of Trial

 

10.0

Introduction

94

10.1

Need of randomization

94

10.2

What is meant by randomized clinical trial

94

10.3

How to randomize

97

10.4

Methods of Randomization

97

10.5

Problems and Additional Benefits of Randomization

99

10.6

Blinding

100

10.7

Masking & Blinding

103

10.8

Placebo & Blinding

103

10.9

Does blinding prevent bias

104

10.10

What to look for in descriptions of blinding

104

Chapter-XI

Phases of Clinical trial

 

11.0

Introduction

106

11.1

Discussion & types of clinical trial (Phase-0 to IV)

107

Chapter-XII

Drug sources and method of identification

 

12.0

Introduction

111

12.1

Discussion on various types of authentication-Herbal, Mineral & Animal origin ingredients with LCMS, HOLC, HPTLC, TLC, AAS etc

111

Chapter-XIII

Good Laboratory Practice (GLP)

 

13.0

Introduction

127

13.1

Aim of GLP

127

13.2

Fundamental points of GLP

127

13.3

OECD-GLP Principles

129

13.4

GLP inspection check list

134

Chapter-XIV

Bio-informatics

 

14.0

Introduction

152

14.1

Why Bioinformatics is so important

152

14.2

Enormity of Genetic Data

152

14.3

Major Bioinformatics Applications

153

14.4

Aim of informatics

153

14.5

Bio-informatics and Ayurveda

154

Chapter- XV

Pharmacovigilance

 

15.0

Introduction

156

15.1

Why is it import

156

15.2

Evolution of Pharmacovigilance

157

15.3

Benefits of Pharmacovigilance

157

15.4

Responsibilities of Pharrnacovigilance

157

15.5

Process in Pharmacovigilance

157

15.6

National Pharmacovigilance Programme for ASU drugs

159

Chapter-XVI

Pharmacoeconomics and Pharmacoepidemiology

 

16.0

Introduction

166

16.1

Methodological issues in conducting pharmacoeconomics evaluation

166

16.2

Types of pharmacoeconomic analysis

167

16.3

Need of Pharmacoeconomics

167

16.4

Pharmacoepidemiology & Ayurvedic Pharmacoepidemiology

167

Chapter- XVII

Pharmacogenomics

 

17.0

Introduction

169

17.1

Pharmacogenomics usefulness

169

17.2

Pharmacogenomics and Ayurveda

170

Chapter- XVIII

RadioBiology

 

18.0

Introduction

172

18.1

Radiation effect of cells

172

18.2

Process of radiation damage

173

18.3

Direct action of radiation damage

173

18.4

Indirect action of cell damage

173

18.5

Fate of irradiated cell

175

18.6

Repair of Radiation Damage

176

18.7

Tissue and Organ Sensitivity to Radiation

176

18.8

Radiation Effects

176

18.9

Deterministic Effects

176

18.10

Thresholds for Deterministic Effects-Health hazard

177

18.11

Stochastic Effects

177

18.12

High Dose Effects

178

18.13

Late Effects of High Dose Radiation

178

Chapter-XIX

Various in-vivo (animal) & in-vitro models of bioresearch

 

19.0

Introduction

179

19.1

Uses of animal model

179

19.2

History of use of animals in research

181

19.3

Types of animal model

181

19.4

In-vitro

182

19.5

Models of in-vitro

182

Chapter-XX

Phamacokinetics and Pharmacodynamics

 

20.1

Pharmacokinetics

185

20.2

Pharmacodynamics

186

20.3

Therapeutic drug monitoring

187

20.4

Process of Pharmacokinetics

189

20.5

Models of Pharmacokinetics

191

20.6

Some terminologies

192

20.7

Applications of Pharmacokinetics in Ayurveda

192

Chapter-XXI

Government organization related to Clinical Research

 

21.1

Clinical Trial Registry of India (CTRI)

194

21.2

Central Drugs Standard Control Organization (CDSCO)

195

21.3

Central Council Of Research In Ayurvedic Sciences (CCRAS)

196

21.4

Indian Council Of Medical Research (ICMR)

198

Chapter-XXII

Intellectual Property Rights (IPR)

 

22.0

What is Intellectual Property Rights

200

22.1

Areas of Intellectual Property- Patent, Trade Mark etc

200

22.2

Types of Intellectual Property- Patent, Trade Mark etc

201

22.3

Ayurveda and Intellectual Properties Rights 203

 

22.4

Organizations associated with Intellectual Property Rights

203

Chapter-XXIII

Protocols

 

23.1

Safety & Toxicity profile evaluation of Ayurveda plants and drugs

207

23.2

Rules No. 170, GSR 893 (E), Drugs & Cosmetic Act (4th Amendment) 2008: Guidelines of evaluation of ASU drugs

209

 


Research Methodology (Methods, Approaches and Techniques)

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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

 

S.N.

Chapter Page

 

Chapter-I

Bioethics-Ethical issues in Biology & Technology

 

1.0

Introduction

1

1.1

Impact

1

1.2

Bioethics & Ayurveda

2

1.3

Other ethical committee

3

Chapter-II

Ethical issues in Clinical Research

 

2.0

Introduction

4

2.1

Ethical & Safety considerations

4

2.2

What should be done when an institution does not have IEC

6

2.3

Format for human ethics approval

11

2.4

Is human ethical review committee- Human (HERC) required?

13

Chapter-III

Product Development Process

 

3.0

Introduction

15

3.1

Drug, Nutrients and Nutraceuticals with utrigenomics

15

3.2

Duration for new product development

17

3.3

Monitoring authorities of Drug Development

17

3.4

Steps involved in new product development process

18

3.5

Ethical issues in product development

19

3.6

Ethical issues in clinical research

20

3.7

Terminologies related to product development

22

3.8

Study of acute, Sub acute and chronic toxicity test

25

Chapter-IV

Research & Pharmaco-poeial standards

 

4.0

Introduction

29

4.1

Ayurvedic Pharmacopoea Committee

29

4.2

Quality control in Ayurvedic drugs-ASU

32

4.3

Important regulatory/legal provisions

33

4.4

Good manufacturing practices (GMP)

34

4.5

Good Agricultural & Collection Practices (GACP)

42

Chapter- V

Good Clinical Practices (GCP)

 

5.0

Introduction

43

5.1

Important definitions

43

5.2

ASU drugs & GCP

50

5.3

Principles of ICH-GCP

50

5.4

Responsibilities of Institutional Review Board (IRB)/Institutional Ethical Committee (IEC)

51

5.5

Composition & Function of IEC

52

5.6

Principles of GCP-Global Stand

54

Chapter- VI

Essentials & Preparatory before Clinical study

 

6.0

General information

56

6.1

Aims & Objectives of the study

56

6.2

Ethical consideration

57

6.3

Study Design

57

6.4

Inclusion, Exclusion and With drawal of subjects

58

6.5

Assessment of efficacy

58

6.6

Assessment of safety

58

6.7

Statistics

58

6.8

Data Handling and Management

59

6.9

Quality control and Quality assurance

59

6.10

Finance and Insurance

59

6.11

Publication Policy

60

6.12

Decision of Ethical Committee

61

Chapter- VII

Informed Consent

 

7.0

Introduction

62

7.1

Process

63

7.2

Notes and steps during emergency condition

66

7.3

Compensation of patients/volunteers

66

7.4

Sample form for the informed consent form

67

Chapter- VIII

Clinical Trial Designs

 

8.0

Introduction

77

8.1

Approach to Classify Clinical Studies According to Objective

78

8.2

Importance of clinical trial design

79

8.3

Types of Clinical designs

81

8.4

Common Designs

84

8.5

Special designs for the small scale trials

85

8.6

Advantages Vs Disadvantages of various designs

87

Chapter-IX

Case Record Form (CRF)

 

9.0

Introduction

90

9.1

Procedure

91

9.2

Collection of Participant Data

91

9.3

Data to be collected on CRF

92

9.4

Audit trials

92

9.5

Check list for handling CRFs

92

Chapter-X

Randomization and Blinding of Trial

 

10.0

Introduction

94

10.1

Need of randomization

94

10.2

What is meant by randomized clinical trial

94

10.3

How to randomize

97

10.4

Methods of Randomization

97

10.5

Problems and Additional Benefits of Randomization

99

10.6

Blinding

100

10.7

Masking & Blinding

103

10.8

Placebo & Blinding

103

10.9

Does blinding prevent bias

104

10.10

What to look for in descriptions of blinding

104

Chapter-XI

Phases of Clinical trial

 

11.0

Introduction

106

11.1

Discussion & types of clinical trial (Phase-0 to IV)

107

Chapter-XII

Drug sources and method of identification

 

12.0

Introduction

111

12.1

Discussion on various types of authentication-Herbal, Mineral & Animal origin ingredients with LCMS, HOLC, HPTLC, TLC, AAS etc

111

Chapter-XIII

Good Laboratory Practice (GLP)

 

13.0

Introduction

127

13.1

Aim of GLP

127

13.2

Fundamental points of GLP

127

13.3

OECD-GLP Principles

129

13.4

GLP inspection check list

134

Chapter-XIV

Bio-informatics

 

14.0

Introduction

152

14.1

Why Bioinformatics is so important

152

14.2

Enormity of Genetic Data

152

14.3

Major Bioinformatics Applications

153

14.4

Aim of informatics

153

14.5

Bio-informatics and Ayurveda

154

Chapter- XV

Pharmacovigilance

 

15.0

Introduction

156

15.1

Why is it import

156

15.2

Evolution of Pharmacovigilance

157

15.3

Benefits of Pharmacovigilance

157

15.4

Responsibilities of Pharrnacovigilance

157

15.5

Process in Pharmacovigilance

157

15.6

National Pharmacovigilance Programme for ASU drugs

159

Chapter-XVI

Pharmacoeconomics and Pharmacoepidemiology

 

16.0

Introduction

166

16.1

Methodological issues in conducting pharmacoeconomics evaluation

166

16.2

Types of pharmacoeconomic analysis

167

16.3

Need of Pharmacoeconomics

167

16.4

Pharmacoepidemiology & Ayurvedic Pharmacoepidemiology

167

Chapter- XVII

Pharmacogenomics

 

17.0

Introduction

169

17.1

Pharmacogenomics usefulness

169

17.2

Pharmacogenomics and Ayurveda

170

Chapter- XVIII

RadioBiology

 

18.0

Introduction

172

18.1

Radiation effect of cells

172

18.2

Process of radiation damage

173

18.3

Direct action of radiation damage

173

18.4

Indirect action of cell damage

173

18.5

Fate of irradiated cell

175

18.6

Repair of Radiation Damage

176

18.7

Tissue and Organ Sensitivity to Radiation

176

18.8

Radiation Effects

176

18.9

Deterministic Effects

176

18.10

Thresholds for Deterministic Effects-Health hazard

177

18.11

Stochastic Effects

177

18.12

High Dose Effects

178

18.13

Late Effects of High Dose Radiation

178

Chapter-XIX

Various in-vivo (animal) & in-vitro models of bioresearch

 

19.0

Introduction

179

19.1

Uses of animal model

179

19.2

History of use of animals in research

181

19.3

Types of animal model

181

19.4

In-vitro

182

19.5

Models of in-vitro

182

Chapter-XX

Phamacokinetics and Pharmacodynamics

 

20.1

Pharmacokinetics

185

20.2

Pharmacodynamics

186

20.3

Therapeutic drug monitoring

187

20.4

Process of Pharmacokinetics

189

20.5

Models of Pharmacokinetics

191

20.6

Some terminologies

192

20.7

Applications of Pharmacokinetics in Ayurveda

192

Chapter-XXI

Government organization related to Clinical Research

 

21.1

Clinical Trial Registry of India (CTRI)

194

21.2

Central Drugs Standard Control Organization (CDSCO)

195

21.3

Central Council Of Research In Ayurvedic Sciences (CCRAS)

196

21.4

Indian Council Of Medical Research (ICMR)

198

Chapter-XXII

Intellectual Property Rights (IPR)

 

22.0

What is Intellectual Property Rights

200

22.1

Areas of Intellectual Property- Patent, Trade Mark etc

200

22.2

Types of Intellectual Property- Patent, Trade Mark etc

201

22.3

Ayurveda and Intellectual Properties Rights 203

 

22.4

Organizations associated with Intellectual Property Rights

203

Chapter-XXIII

Protocols

 

23.1

Safety & Toxicity profile evaluation of Ayurveda plants and drugs

207

23.2

Rules No. 170, GSR 893 (E), Drugs & Cosmetic Act (4th Amendment) 2008: Guidelines of evaluation of ASU drugs

209

 


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