Nilesh Panchal

Mastering Biologics License Applications (BLA): A Step-by-Step Approach (Mastering the FDA Approval Process, #4) (eBook, ePUB)

• Format: ePub

Produktbeschreibung

Mastering Biologics License Applications (BLA): A Step-by-Step Approach is a comprehensive guide designed to simplify the intricate process of gaining approval for biologics. This book takes readers through every phase of the BLA journey, from understanding the regulatory landscape to navigating preclinical studies, clinical trials, and manufacturing requirements. With detailed insights into Chemistry, Manufacturing, and Controls (CMC), as well as practical strategies for risk management and post-marketing commitments, this guide equips biologics developers with the knowledge and tools needed to succeed. Whether you are a regulatory professional, a biotech entrepreneur, or a pharmaceutical researcher, this book offers a clear and structured roadmap to mastering the complexities of BLA submissions and achieving market approval.

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Produktdetails

• Verlag: DrMedHealth
• Erscheinungstermin: 14. November 2024
• Englisch
• ISBN-13: 9798230399711
• Artikelnr.: 72286105

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.