The Quintessence of Basic and Clinical Research and Scientific Publishing

Gowraganahalli Jagadeesh, Ph.D. has worked for more than three decades for the US Food and Drug Administration as a Senior Expert Pharmacologist in the Office of Cardiology, Hematology, Endocrinology, and Nephrology at the Center for Drug Evaluation and Research. He was an Adjunct Scientist at the NIH, Bethesda while working at the FDA. He had also taught at Banaras Hindu University, Varanasi, India, and was a Canadian Heart Foundation Fellow and NIH staff scientist (at Northeastern University, Boston). Dr. Jagadeesh received B. Pharm, MSc and Ph.D. degrees from RGUS-Bengaluru, All-India Institute of Medical Sciences-Delhi, and BHU, respectively. He is currently a Distinguished Visiting Professor at College of Pharmaceutical Sciences, Dayananda Sagar University, Bengaluru; and a visiting professor at College of Pharmacy, Adichunchanagiri University, BG Nagara, Karnataka; and College of Pharmaceutical Sciences, Manipal Academy of Higher Education (Deemed-to-be University), Manipal, India. More than 60 scientific papers, including book chapters, have been authored by him, and he has edited three books as well.   Pitchai Balakumar, M.Pharm., Ph.D. is working as Professor & Director, Centre for Scholarly Scientific Training and Publishing, The Office of Research and Development, Periyar Maniammai Institute of Science & Technology (Deemed-to-be University), Vallam, Tamil Nadu, India. Previously, he was a Professor of Pharmacology at King Khalid University, Saudi Arabia, and Senior Associate Professor and Head of Pharmacology Unit at the Faculty of Pharmacy, AIMST University, Malaysia. He was the Visiting Scientist at the University of Montreal, Canada in 2009. Prof. Balakumar’s name has been featured, for the third consecutive time (since 2020), among the World Ranking Top 2% Scientists in the Field: Pharmacology & Pharmacy, based on a study done by Stanford University scientists. He obtained M.Pharm and Ph.D. degrees in Pharmacology specialized in Cardiovascular Pharmacology from Punjabi University-Patiala, Punjab, India. He has two decades of teaching, research and editorial experience in the field of Cardiovascular-Renal Sciences, and trained several graduates in India and abroad. He has published around 125 scientific papers (over 5350 citations with h-index 40), and received several awards and honors for excellence in overall academic and research performance. Along with two senior scientists from the US FDA, Prof. Balakumar edited a reference book titled ‘Pathophysiology and Pharmacotherapy of Cardiovascular Disease’ published by Springer in 2015. He also edited a number of focused Special Issues in cardiovascular sciences. Prof. Balakumar is a 'Consulting Editor' at Pharmacological Research-Elsevier.   Fortunato Fred Senatore, MD, PhD, FACC received his bachelor degree in biochemistry and master degree in biomedical engineering from Columbia University, and Ph.D. in chemicalengineering from Rutgers University. He served as an assistant professor of chemical engineering at Texas Tech University and focused on artificial organ research and biocompatible prostheses. He attended medical school at the Texas Tech University School of Medicine during his tenure at the Texas Tech University School of Engineering. He trained in Internal Medicine at the Mayo Clinic and Cardiology at Harvard University-Massachusetts General Hospital. He served in the pharmaceutical industry with increasing levels of responsibility for 17 years where he conducted and supervised clinical research in cardiovascular disease, renal disease, and endocrinology. He subsequently joined the FDA in the Division of Cardiology and Nephrology and has been serving as Medical Officer since 2012. For the past four years, he has been serving as Lead Physician.

Chapter 1. The Roadmap to Research: Fundamentals of a Multifaceted Research Process.- Chapter 2. Processes involved in the generation of novel ideas.- Chapter 3. Creativity and critical thinking contribute to scholarly achievement.- Chapter 4. Writing protocols in Pharmacological studies.- Chapter 5. Basics of Designing General Toxicology Studies.- Chapter 6. General design considerations in Reproductive and developmental toxicity studies.- Chapter 7. Genetic toxicology studies.- Chapter 8. Rodent Carcinogenicity Studies.-Chapter 9. Designing studies in pharmaceutical and medicinal chemistry.- Chapter 10. Experimental protocols in phytochemistry and natural products: an ever-evolving challenge.- Chapter 11. Drug substance/ product quality analysis (Quality assessment).- Chapter 12. Drug Delivery Systems: Lipid Nanoparticles Technology in Clinic.- Chapter 13. Pharmacokinetic studies for drug development.- Chapter 14. New Alternative Methods in drug safety assessment.- Chapter 15. Animal models for the study of human disease.- Chapter 16. Physiologically based Pharmacokinetic Modelling in Drug Discovery and Clinical Development: A Treatise on Concepts, Model Workflow, Credibility, Application and Regulatory Landscape.- Chapter 17. Design and conduct of pharmacokinetics studies influenced by extrinsic factors.- Chapter 18.  Specific Populations: Clinical Pharmacology Considerations.- Chapter 19. Impact of genetic variation on drug response.-Chapter 20. Phases of clinical trials.- Chapter 21. Common clinical trial designs.- Chapter 22. Elements of clinical trial protocol design.- Chapter 23. Good clinical practice in clinical trials, substantial evidence of efficacy, and interpretation of the evidence.- chapter 24. Grandfathered Drugs of 1938 in the United States.- Chapter 25. General overview of the statistical issues in clinical studydesigns.- Chapter 26. Introduction to pharmacoepidemiology and its application in clinical research.- Chapter 27. Pharmacovigilance through phased clinical trials, post-marketing surveillance and ongoing life cycle safety.- Chapter 28. The design and statistical analysis of randomized pre-clinical experiments.- Chapter 29. Descriptive and Inferential Statistics in Biomedical Sciences: an overview.- Chapter 30.  Principles and applications of statistics in biomedical research: parametric and non-parametric tests including tests employed for Post-hoc analysis.- Chapter 31. Artificial intelligence generative chemistry design of target-specific scaffold-focused small molecule drug libraries.- Chapter 32. Artificial intelligence technologies for clinical data pharmacoanalytics. Case studies on Alzheimer’s disease.- Chapter 33. Bioinformatics: Theory and Application.- Chapter 34. Drug targets and drug discovery research.- Chapter 35. Role of Nonclinical Programs in Drug Development.- Chapter 36. Drug repurposing: strategies and study design in bringing back old drugs to the mainline.- Chapter 37. Empowering knowledge on efficient literature search: an overview of biomedical search engines and databases.- Chapter 38. Literature Reviews: An Overview of Systematic, Integrated, and Scoping Review.- Chapter 39. How To Create A Bibliography.- Chapter 40. Publication metrics /Bibliometrics.- Chapter 41. How to write a scientific paper.- Chapter 42. Preparing and structuring a manuscript for publication.- Chapter 43. Writing a scientific article.- Chapter 44. How to Present Results in a Research Paper.- Chapter 45. Communicating results of quantitative research.- Chapter 46. How to Efficiently Write a Persuasive Discussion Section.- Chapter 47. Submitting a manuscript for publication, the peer review process, and getting past the gatekeepers.- Chapter 48. Writing a Postgraduate or Doctoral Thesis: A Step-by-Step Approach.- Chapter 49. Poster presentation at scientific meetings .- Chapter 50. Strategies for the preparation and delivery of oral presentation.- Chapter.-51. Grant Process and Peer Review ─ US National Institutes of Health System.- Chapter 52. Rigor and specifics in writing research proposal.- Chapter 53. Writing research grant proposals ─ from an Indian Perspective.- Chapter 54. Funding opportunities (resources) in biomedical sciences: Indian perspective.- Chapter 55. Mentorship in biomedical sciences.- chapter 56. Commercializing the technology – transitioning from the academic lab to the market.- Chapter 57. Patent law fundamentals for biomedical scientists.- Chapter 58. Research integrity: responsible conduct of research.- Chapter 59. Publication integrity, authorship, and misconduct.