Navigating ANDA

Strategies for Effective Generic Drug Approval

Dr Nilesh Panchal

$89.95 $76.15

Paperback

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English

Drmedhealth
08 October 2024

Epidemiology & medical statistics; Pharmacology

Series: Mastering the FDA Approval Process

Navigating ANDA: Strategies for Effective Generic Drug Approval provides a comprehensive roadmap for pharmaceutical professionals seeking to understand and master the Abbreviated New Drug Application (ANDA) process. This book delves into the intricacies of FDA regulations, offering practical strategies for preparing, submitting, and obtaining approval for generic drugs. With insights into bioequivalence requirements, patent challenges, and post-approval obligations, it equips readers with the tools needed to overcome common hurdles in the ANDA journey. Whether you are new to the field or a seasoned expert, this guide will help you navigate the complexities of generic drug approval and achieve success in a competitive market.

By: Dr Nilesh Panchal
Imprint: Drmedhealth
Volume: 2
Dimensions: Height: 216mm, Width: 140mm, Spine: 12mm
Weight: 277g
ISBN: 9798227382818
Series: Mastering the FDA Approval Process
Pages: 214
Publication Date: 08 October 2024
Audience: General/trade , ELT Advanced
Format: Paperback
Publisher's Status: Active

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.