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Biomedical Research. From Ideation to Publication

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Invaluable Text for PG’s,
Aspiring & Experienced
Researchers in Biomedical &
Life Sciences

Editors
G. Jagadeesh, Ph.D.
Sreekant Murthy, Ph.D.
Y.K. Gupta, M.D.
Amitabh Prakash, M.D.

PRICE
INR 695.00
ONLY

ISBN: 978-81-8473-200-9 • Pub. Month: Dec. '09 • Pages: 594 • Illustrations: 56 • Tables: 113 (Approx.) • Format: Paperback
Biomedical Research From Ideation to Publication

BOOK DESCRIPTION FEATURES

Specially designed for aspiring researchers, this book presents a systematic • The importance of creativity as well as of critical thinking is
exposition of the basic principles and methodologies involved in biomedical research. discussed.
The book covers the entire research process from the conception of an idea, its • Research protocols and proposal development
development, investigation and execution, and finally to its publication. Various
research methodologies including study design and statistical approaches to data • Literature review
analysis are also discussed in detail. The importance of ethics and integrity in research • Guidelines for writing good scientific papers
is highlighted extensively. In addition, the book discusses relevant issues relating to • Pathways to publication
the commercialization of research innovations and outlines the steps necessary for • Research support and grants
successful entrepreneurship.

Table Of Contents
Section A: Getting Started in Research
ABOUT THE AUTHORS 1. Creative and Critical Thinking in Biomedical
Research
G. Jagadeesh, Ph.D. 2. Research: A Burning Passion to Discover
3. The Four Cornerstones of a Research Project:
Expert Pharmacologist
Division of Cardiovascular and Renal Products Health Problem in Focus, Objectives, Hypothesis,
Center for Drug Evaluation and Research, Research Question
US Food and Drug Administration, 4. An Overview of the Research Process
Silver Spring, MD 20993, USA Section B: Planning for Non-Clinical Science
Research
5. Writing a Research Protocol in Pharmacology and
Sreekant Murthy, Ph.D. Toxicology
Professor of Medicine 6. Research Methods in Ion Channel Biology
Professor of Biomedical Engineering
7. Writing Protocols for Preclinical Drug Disposition
Vice Provost for Research Compliance (ADME) Studies
Office of Regulated Research Compliance
8. Pharmaceutics and Drug Delivery Research
Drexel University College of Medicine
Philadelphia, PA 19102, USA 9. Research in Nanomedicine Technologies
10. Pharmacogenomics: From Statistics to
Mechanisms and Applications
Y.K. Gupta, M.D.
11. Alternatives to Animal Experimentation in
Professor & Head Research
Department of Pharmacology Section C: Planning for Clinical Research
Editor, Indian Journal of Physiology and
12. Clinical Science Research
Pharmacology
13. Principles of Study Designs in Clinical Research
All India Institute of Medical Sciences,
New Delhi 110029, India 14. Writing a Clinical Trial Protocol
15. Clinical Pharmacology: Characterisation of a Drug
Product
Amitabh Prakash, M.D.
16. Bioavailability / Bioequivalence: Study
Editor Considerations
Clinical Pharmacokinetics and the American
Section D: Study Design and Statistical Analysis
Journal of Cardiovascular Drugs
Wolters Kluwer | Adis 17. Statistics in Pharmacology
Auckland, New Zealand 18. Design and Statistical Analysis of Toxicology
Studies
19. Statistical Consideration: Design and Approaches
for Bioequivalence and Bioavailability Studies
Section E: Exploring the Literature for Reaching
Ideas
20. Comprehensive Review of the Literature
21. Finding Information in Medical Sciences:
Searching the Medical Literature
Section F: Scientific Communication
22. How to Write a Good Scientific Paper
23. ABC of Medical Writing: Language and Style in
Scientific Communication
24. Structure of a Scientific Paper in Biomedical
Sciences
25. How to Structure an Abstract, Title and
Introduction
26. Writing the Results
27. Writing a 'Discussion' Section in a Medical
Article: An Exercise in Critical Thinking and
Argumentation
28. Synthesis of a Thesis
29. Reference Style and Common Errors with
Referencing
Section G: Tools for Scholarly Publications
30. Working with Journals: Cover Letter to the
Journal, Peer Review and Revision Process
31. Health Research Reporting Guidelines:
An Overview
Section H: Seeking Research Support
32. How to Write a Successful Research Proposal:
The Science, Art and Economics of it
33. Writing a Grant Proposal
34. Funding Opportunities in Biomedical Sciences
and Preparing a Successful Grant Application
Section I: Innovation in Career
35. Beyond Knowledge for Knowledge's Sake
Section J: Research and Publication Integrity
36. Research Ethics for the Biomedical Sciences

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 CHAPTER 35  Beyond Knowledge for Knowledge’s Sake v

Preface

The principles for excellence in scientific research are many-fold. Chief among them is that scientific research
must be purposive.. Further, research must follow standard processes and norms. These processes must
involve the development of a testable hypothesis, vigorous testing of this hypothesis, paying particular
attention to the variables, and rigorous conduct of the investigation using appropriate and contemporary
methodologies. The research must be accurate and reproducible and researchers must have the ability to
view things objectively by taking a broad view of research accomplishments. Finally, the research findings
must be communicated to peers and the wider society in an accurate, succinct and clear manner.
These basic tenets of research are unfortunately not innate to everyone. Therefore, the vast majority of
young researchers with a passion to discover require guidance from experienced researchers. This will help
them to progress successfully from the development of an idea to its execution and eventual publication.
Such guidance should enable researchers to achieve the highest honor in their chosen field of research.
This book is an attempt to provide this guidance to aspiring researchers. It addresses the required core
competencies by covering the following topics: creativity, critical thinking, passion to discover, research pro-
tocol and proposal development, statistical analysis, ethical and responsible conduct of research, publication
ethics, pathways to publication and finally commercialization of research innovations. These areas are often
unfamiliar to young investigators and our intent is to provide accurate information, succinct explanations and
useful advice. After reading the book, we hope that aspiring researchers will understand that their approach
should be innovative and scholarly and appreciate that research is undertaken to discover, interpret, and
revise existing knowledge through perpetual questioning. This questioning, when put into a systematic
framework, creates a multitude of additional ideas that generate new topics for investigation.
For ease of use, the book is divided into number of distinct groups of chapters. Many chapter authors
and contributors have provided examples of research methodologies, including statistical approaches for
the analysis of data. We have included pertinent chapters that discuss the actual writing of a scientifically
and intellectually sound research manuscript and publication etiquette on how to respond to journal edi-
tor’s and reviewers’ queries.
Albert Einstein once remarked, “Many people say that it is the intellect which makes a great scientist. They
are wrong; it is character.” Several chapters in the book address the issue of integrity in scientific research, at
the bench, and in publication. They highlight how integrity will improve research outcomes, reduce nega-
tive consequences, and improve the credibility of the research enterprise and the importance of scientific
findings.
Finally, yet importantly, researchers and research institutions are in the midst of substantial change and
are becoming entrepreneurial. This book addresses those needs and outlines steps to be taken to become a
successful entrepreneur.

Prelims.indd v 11/16/2009 11:54:13 AM

 vi  Preface

In essence, this book is intended to provide impetus to young researchers to build successful scientific careers
and help them conduct research using well developed, appropriate, and established scientific methods.
This book could not have been written without the invaluable contributions from chapter authors and
co-authors whose inquisitive minds, perseverance and opinions provide a solid foundation for the many
aspects of scientific investigation that a researcher has to master. We thank all the authors and co-authors
for their time and effort in preparing these chapters.
We hope that aspiring researchers may find this book useful. Comments and suggestions for its further
improvement will be gratefully received and acknowledged.

G. Jagadeesh, Ph.D.
Sreekant Murthy, Ph.D.
Y. K. Gupta, M.D.
Amitabh Prakash, M.D.

Prelims.indd vi 11/16/2009 11:54:13 AM

 CHAPTER 35  Beyond Knowledge for Knowledge’s Sake vii

Contents

Preface v

Contributors vii

Section A: Getting Started in Research

1. Creative and Critical Thinking in Biomedical Research 3
2. Research: A Burning Passion to Discover 18
3. The Four Cornerstones of a Research Project: Health Problem in
Focus, Objectives, Hypothesis, Research Question 28
4. An Overview of the Research Process 36

Section B: Planning for Nonclinical Science Research

5. Writing a Research Protocol in Pharmacology and Toxicology 51
6. Research Methods in Ion Channel Biology 72
7. Writing Protocols for Preclinical Drug Disposition (ADME) Studies 93
8. Pharmaceutics and Drug Delivery Research 111
9. Research in Nanomedicine Technologies 127
10. Pharmacogenomics—From Statistics to Mechanisms and Applications 142
11. Alternatives to Animal Experimentation in Research 155

Section C: Planning for ClinicalResearch

12. Clinical Science Research 181
13. Principles of Study Designs in Clinical Research 199
14. Writing a Clinical Trial Protocol 226
15. Clinical Pharmacology: Characterisation of a Drug Product 259
16. Bioavailability/Bioequivalence—Study Considerations 277

Prelims.indd vii 11/16/2009 11:54:13 AM

 viii  Contents

Section D: Study Design and Statistical Analysis

17. Statistics in Pharmacology 291
18. Design and Statistical Analysis of Toxicology Studies 338
19. Statistical Consideration: Design and Approaches for Bioequivalence
and Bioavailability Studies 367

Section E: Exploring the Literature for Reaching Ideas

20. Comprehensive Review of the Literature 377
21. Finding Information in Medical Sciences—Searching the Medical Literature 388

Section F: Scientific Communication

22. How to Write a Good Scientific Paper 411
23. ABC of Medical Writing: Language and Style in Scientific Communication 421
24. Structure of a Scientific Paper in Biomedical Sciences 428
25. How to Structure an Abstract, Title and Introduction 444
26. Writing the Results 448
27. Writing a ‘Discussion’ Section in a Medical Article: An Exercise in
Critical Thinking and Argumentation 457
28. Synthesis of a Thesis 466
29. Reference Style and Common Errors with Referencing 479

Section G: Tools for Scholarly Publications

30. Working with Journals: Cover Letter to the Journal, Peer Review and Revision Process 491
31. Health Research Reporting Guidelines: An Overview 500

Section H: Seeking Research Support

32. How to Write a Successful Research Proposal: The Science, Art and Economics of It 509
33. Writing a Grant Proposal 519
34. Funding Opportunities in Biomedical Sciences and Preparing a
Successful Grant Application 527

Section I: Innovation in Career

35. Beyond Knowledge for Knowledge’s Sake 555

Section J: Research and Publication Integrity

36. Research Ethics for the Biomedical Sciences 563
Index 589

Prelims.indd viii 11/16/2009 11:54:13 AM

 584  Contributors
Contributors
C. Adithan, MD, PhD, DNB
Director, Professor and Head
Department of Pharmacology
Jawaharlal Institute of Postgraduate Medical
Education and Research
Puducherry 605 006, India
Victoria A Cartwright, BA (Hons.)
Managing Editor, Clinical and Experimental
Ophthalmology
Faculty of Medical and
Health Sciences
University of Auckland
85 Park Road
Auckland 1142, New Zealand
Kalyan Chakravarthy
Research Assistant
School of Biomedical Sciences
Engineering and Health Systems
Drexel University
3141 Chestnut Street
Philadelphia, PA 19104, USA
Shripad B. Deshpande, MD, PhD
Professor and Head
Department of Physiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi 221 005, UP, India
Contributors.indd 584
Angelica M. Dorantes
Acting Team Leader
Division of Clinical Pharmacology I
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
US Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA
Susan M. Foggin, MA, DipNZLS
Philson Library Information Services Manager
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road, Auckland 1142, New Zealand
Srinivas Ghatta, PhD
Principal Scientist
Neuronal Ion Channel Biology
Respiratory Center of Excellence in
Drug Discovery
GlaxoSmithKline
709 Swedeland Road
King of Prussia, PA 19406, USA
Frederick L. Grover, MD
Professor and Aragón/Gonzalez-Giusti Chair
Department of Surgery
Director, Lung Transplantation
University of Colorado Health Sciences Center
Anschutz Medical Center, Academic Office One
12631 E. 17th Avenue, Aurora, CO 80045, USA
11/2/2009 3:41:05 PM
 Contributors  585

Anil Gulati, MD, PhD Andres Kriete, PhD

Associate Dean and Professor School of Biomedical Engineering, Science, and
Midwestern University Health Systems
Chicago College of Pharmacy Drexel University
555 31st Street 3141 Chestnut Street
Downers Grove, IL 60515, USA Philadelphia, PA 19104, USA

Y. K. Gupta, MD, FAMS, FNASc, FIPS Gopala Krishna, PhD, DABT, MBA
Editor, Indian Journal of Physiology and Pharmacol- Senior Director and Head
ogy (Pharmacology) Department of Preclinical
Professor and Head Candidate Evaluation
Department of Pharmacology Supernus Pharmaceuticals, Inc.
All India Institute of Medical Sciences 1550 E. Gude Drive
New Delhi 110 029, India Rockville, MD 20850, USA

Gowraganahalli Jagadeesh, PhD Arun Kumar, DBA, DVM, PhD

Expert Pharmacologist Senior Scientist and Head
Division of Cardiovascular and Renal Products (Functional Biology)
Office of Drug Evaluation 1, Office of New Drugs Department of Medicine
Center for Drug Evaluation and Research (Cardiovascular Sciences)
US Food and Drug Administration Bioscience Institute,
10903 New Hampshire Avenue University College Cork
Silver Spring, MD 20993, USA College Road, Cork, Ireland

Milos Jenicek, MD, PhD, FRCPC, CSPQ Karl K. Lin, PhD

Professor (McMaster), Professor Emeritus Supervisory Statistical Reviewer
(Montréal), Division of Biometrics 6,
Adjunct Professor (McGill) Office of Biostatistics,
Department of Clinical Epidemiology & Center for Drug Evaluation and Research
Biostatistics US Food and Drug Administration
Faculty of Health Sciences 10903 New Hampshire Avenue
Michael G. DeGroote School of Medicine Silver Spring, MD 20993, USA
McMaster University
1200 Main Street West Patrick J. Marroum, PhD
Hamilton, Ontario, L8N 3Z5, Canada Special Assistant to the Office Director
Office of New Drug Quality Assessment
Dhananjaya V. Kalvakolanu, PhD Center for Drug Evaluation and Research
Professor US Food and Drug Administration
Department of Microbiology & Immunology 10903 New Hampshire Avenue
Greenebaum Cancer Center Silver Spring, MD 20993, USA
University of Maryland School of Medicine
660 West Redwood Street Robert B. McGrath, PhD
Howard Hall Suite 324 Executive Director & Associate Vice Provost
Baltimore, MD 21201, USA Entrepreneurship and Technology
Commercialization
Kallappa M. Koti, PhD Drexel University
Mathematical Statistician 3141 Chestnut Street
Office of Biostatistics Philadelphia, PA 19104, USA
Center for Drug Evaluation and Research
US Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA

Contributors.indd 585 11/2/2009 3:41:05 PM

 586  Contributors

Keith A Meadows, AMRS, BA, PhD Sreekant Murthy, PhD

Associate Director of Research & Professor of Medicine
Development Professor of Biomedical Engineering
NHS Tower Hamlets Department of Internal Medicine
Mile End Hospital Vice Provost for Research Compliance
2nd Floor, Aneurin Bevan House
Drexel University College of Medicine
81-91 Commercial Road
3-Parkway, 1600 Cherry Street
London E1 1RD, UK
and Philadelphia, PA 19102, USA
DHP Research & Consulting B.M. Padhy, MD
113 Lower Camden Senior Resident
Chislehurst
Department of Pharmacology
Kent BR7 5JD, UK
All India Institute of Medical Sciences
Gerald O. McDonald, MD New Delhi 110 029, India
Senior Consultant for Surgery
Ravikumar Peri, PhD, DABT
Department of Veterans Affairs, Central Office
Principal Research Scientist II
Office of Patient Care Services
Neurodegeneration Research
810 Vermont Avenue NW
Wyeth Research
Washington, DC 20420, USA
865 Ridge Road
Divya Menon-Andersen, PhD Monmouth Junction, NJ 08852, USA
Reviewer
Constance Perry, PhD
Division of Clinical Pharmacology I
Associate Professor
Office of Clinical Pharmacology
Health and Society Programs
Center for Drug Evaluation and Research
College of Nursing and Health Professions
US Food and Drug Administration
Drexel University
10903 New Hampshire Avenue
Mail Stop 1030
Silver Spring, MD 20993, USA
1505 Race Street, Room 525
Elena V. Mishina, PhD Philadelphia, PA 19102, USA
Senior Clinical Pharmacologist
Omathanu P. Perumal, PhD
Division of Clinical Pharmacology I
Assistant Professor
Office of Clinical Pharmacology
Department of Pharmaceutical Sciences,
Center for Drug Evaluation and Research
College of Pharmacy
US Food and Drug Administration
116 Intramural Building
10903 New Hampshire Avenue
South Dakota State University
Silver Spring, MD 20993, USA
Brookings, SD 57007, USA
Sakya Mohapatra
Satheesh K. Podaralla, MPharm, PhD Student
Research Assistant
Department of Pharmaceutical Sciences,
School of Biomedical Sciences
College of Pharmacy
Engineering and Health Systems
116 Intramural Building
Drexel University
South Dakota State University
3141 Chestnut Street
Brookings, SD 57007, USA
Philadelphia, PA 19104, USA

Contributors.indd 586 11/2/2009 3:41:05 PM

 Contributors  587

Amitabh Prakash, MD, FIPS Trevor Sherwin, PhD

Editor, Clinical Pharmacokinetics and the American Associate Professor
Journal of Cardiovascular Drugs Department of Ophthalmology
Wolters Kluwer Health | Adis Faculty of Medical and Health Sciences
41 Centorian Drive, Private Bag 95601 University of Auckland
85 Park Road
North Shore 0754
Auckland 1142, New Zealand
Auckland, New Zealand
A. Laurie W. Shroyer, PhD, MSHA
Mohammad Atiar Rahman, PhD Department of Veterans Affairs
Senior Statistical Reviewer Health Science Officer,
Division of Biometrics 6, Office of Biostatistics Northport Veterans Affairs Medical Center
Center for Drug Evaluation and Research Research and Development Office
US Food and Administration 79 Middleville Road.
10903 New Hampshire Avenue Northport, NY 11768, USA
Silver Spring, MD 20993, USA and
Program Director, Ph.D.
D. Samba Reddy, PhD, RPh Program in Population Health and
Associate Professor Clinical Outcomes Research
Department of Neuroscience and Experimental Professor of Preventive Medicine,
Therapeutics Division of Evaluative Sciences
College of Medicine Graduate Program in Public Health
Texas A&M Health Science Center Stony Brook University School of Medicine
228 Reynolds Medical Building 100 Nicolls Road
College Station, TX 77843, USA Stony Brook, NY 11794, USA

Fredricka K. Reisman, PhD Bettadapura N. Srikumar, PhD

Interim Associate Dean for Research Laboratoire ‘Physiologie Cellulaire de la Synapse’
Professor, Goodwin College of Professional UMR 5091, Institut François Magendie
Studies Université Bordeaux 2
Director, Drexel/Torrance Center for Creativity 146 rue Léo Saignat,
and Innovation 33077 Bordeaux Cedex,
Drexel University France
3141 Chestnut Street
Philadelphia, PA 19104, USA Visish Srinivasan, PhD
Department of Biology
Pradeep Sharma, PhD Drexel University
Senior Research Scientist 3141 Chestnut Street
Clinical Pharmacology and DMPK Philadelphia, PA 19104, USA
AstraZeneca R & D
Charnwood Bakewell Road, Loughborough Rosie Stather, MA
Leics LE11 5RH, England Editor, Drug Safety
Editorial Manager, Adis Publications
K. Satyanarayana, PhD Wolters Kluwer Health | Adis
Editor, Indian Journal of Medical Research 41 Centorian Drive, Private Bag 95601
Senior Deputy Director-General North Shore 0754
Indian Council of Medical Research Auckland, New Zealand
Ansari Nagar, New Delhi 110 029, India.

Contributors.indd 587 11/2/2009 3:41:05 PM

 588  Contributors
Steven F. Thomson, PhD
Statistical Reviewer
Division of Biometrics 6, Office of Biostatistics,
Center for Drug Evaluation and Research,
US Food and Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA
Khin Maung U, MBBS, MMedSc, MD
(NSW, Australia), MD, FACP
Senior Medical Officer
Division of Cardiovascular and Renal Products
Office of Drug Evaluation 1, Office of New Drugs
Center for Drug Evaluation and Research
US Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA
Ramana S. Uppoor, PhD
Deputy Director
Division of Clinical Pharmacology I
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
US Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA
Contributors.indd 588
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Charles W. Van Way, III, MD
Professor of Surgery
Former Editor-in-Chief, Journal of Parenteral and
Enteral Nutrition
Sosland / Missouri Endowed Chair of Trauma
Services
Director, Shock Trauma Research Center
School of Medicine, University of Missouri –
Kansas City
2301 Holmes Street
Kansas City, MO 64108, USA
Islam Younis, PhD
Reviewer
Division of Clinical Pharmacology I
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
US Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993, USA
11/2/2009 3:41:05 PM