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Clinical Research: Principles, Practice, and Regulation
Modern medicine depends on clinical research to transform scientific discovery into safe and effective therapies. Behind every approved treatment lies a complex system of study design, ethical oversight, regulatory evaluation, and rigorous data analysis.
Clinical Research: Principles, Practice, and Regulation explores how this system works—from the earliest stages of drug discovery to the conduct of clinical trials and the regulatory decisions that bring new therapies to patients. The book examines the scientific and ethical questions that guide modern investigation: How are clinical trials designed to generate reliable evidence? How are risks balanced against potential benefits for participants? What role do ethics committees, investigators, sponsors, and regulators play in safeguarding research integrity?
Drawing on global standards such as Good Clinical Practice and international regulatory frameworks, the book explains the structure of Phase I–IV trials, real-world evidence generation, safety monitoring, and data governance. Operational aspects—including trial organization, monitoring, documentation, and regulatory inspections—are also examined.
Written for postgraduate students, researchers, investigators, and clinical trial professionals, this book provides a clear view of the scientific, ethical, and regulatory foundations that shape modern clinical research.
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Dr. Thalugula Sunitha, Dr. Nerella Mounika, Rajesh Oruganti
Dr. Thalugula Sunitha is an Indian pharmaceutical researcher and academician
specializing in pharmacology & Toxicology and novel drug delivery systems, affiliated
with the University College of Pharmaceutical Sciences, Kakatiya University,
Warangal, Telangana State, India. She holds a Ph.D. in Pharmaceutical Sciences
and working on anti-diabetic research, nanomedicine, and phytochemical analysis.
Dr. Nerella Mounika earned her Doctorate from Mewar University, Rajasthan, in
2022. She is currently serving as an Assistant Professor at Anurag University,
Hyderabad, Telangana, India. She completed both her Bachelor’s and Master’s
degrees from Kakatiya University, Warangal. Dr. Mounika has 11 years of academic
and research experience.
Mr. Rajesh Oruganti Currently serving as Assistant Professor at Chaitanya deemed to be
University, Telangana, India. He completed both his Bachelor’s and Master’s degrees
from Kakatiya University, Warangal. Mr. Oruganti having 8 years of academic and
research experience, and having 5 years’ experience as statistical programmer
