Nilesh Panchal

Navigating the Investigational New Drug (IND) Applications: A Comprehensive Guide (Mastering the FDA Approval Process, #6) (eBook, ePUB)

• Format: ePub

Produktbeschreibung

Navigating the Investigational New Drug (IND) Applications: A Comprehensive Guide is a detailed resource for professionals involved in drug development, regulatory affairs, and clinical research. This guide offers a step-by-step approach to understanding the intricacies of the IND application process, providing insight into the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Covering everything from preclinical studies and clinical trial design to safety reporting and FDA interactions, this book equips readers with the knowledge to successfully navigate the IND submission journey. With practical tips, real-world examples, and a focus on compliance, this comprehensive guide is an essential tool for ensuring the smooth progression of investigational drugs from the lab to human trials.

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Produktdetails

• Verlag: DrMedHealth
• Erscheinungstermin: 14. November 2024
• Englisch
• ISBN-13: 9798230589969
• Artikelnr.: 72285348

Autorenporträt

Dr. Nilesh Panchal is a distinguished Public Health Practitioner and Health Scientist with over two decades of experience, making significant contributions to the fields of infectious diseases, mental health, and public health education. Holding a DrPH in Public Health Practice, Dr. Panchal is a prolific author known for his ability to translate complex medical concepts into accessible and engaging content for a broad audience. His work, including the acclaimed series "Global Outbreaks: The Saga of Humanity's Health Battles," provides invaluable insights into the challenges posed by infectious diseases, making it an authoritative source for understanding humanity's ongoing battle against deadly pathogens. Dr. Panchal's dedication to educating the public extends to his "Mindfulness and Well-Being Series," where his compassionate and practical approach empowers readers to enhance their mental and emotional well-being.

In addition to his focus on infectious diseases and mental health, Dr. Panchal has made remarkable strides in lifestyle medicine, particularly in the prevention of diabetes. His book series "Healthy Living, Healthy Future: Diabetes Prevention Series" offers evidence-based strategies that empower individuals to make lasting lifestyle changes for a healthier, diabetes-free life. Dr. Panchal's commitment to public health is also reflected in his guide "Essential First Aid: Life-Saving Techniques for Everyone," where he provides clear, step-by-step instructions for managing emergencies. Through his extensive research, Dr. Panchal continues to be a respected voice in global health, contributing to medical journals, speaking at international conferences, and leading health innovation projects aimed at integrating AI into clinical practice. His body of work not only informs but also inspires, making a lasting impact on global health practices and public education.