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 |
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 |