Navigating FDA Drug Approval

Par : Dr. Nilesh Panchal
Offrir maintenant
Ou planifier dans votre panier
Disponible dans votre compte client Decitre ou Furet du Nord dès validation de votre commande. Le format ePub protégé est :
  • Compatible avec une lecture sur My Vivlio (smartphone, tablette, ordinateur)
  • Compatible avec une lecture sur liseuses Vivlio
  • Pour les liseuses autres que Vivlio, vous devez utiliser le logiciel Adobe Digital Edition. Non compatible avec la lecture sur les liseuses Kindle, Remarkable et Sony
  • Non compatible avec un achat hors France métropolitaine
Logo Vivlio, qui est-ce ?

Notre partenaire de plateforme de lecture numérique où vous retrouverez l'ensemble de vos ebooks gratuitement

Pour en savoir plus sur nos ebooks, consultez notre aide en ligne ici
C'est si simple ! Lisez votre ebook avec l'app Vivlio sur votre tablette, mobile ou ordinateur :
Google PlayApp Store
  • FormatePub
  • ISBN8227636478
  • EAN9798227636478
  • Date de parution25/09/2024
  • Protection num.Adobe DRM
  • Infos supplémentairesepub
  • ÉditeurBig Dog Books, LLC

Résumé

"Navigating FDA Drug Approval: A Comprehensive Guide to Application Success" is an essential resource for pharmaceutical professionals, researchers, and innovators seeking to bring their drug products to market. This book demystifies the complex FDA approval process, providing step-by-step guidance on everything from preclinical trials to New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Biologics License Applications (BLA).
Packed with insights into expedited approval pathways, labeling requirements, post-marketing surveillance, and key FDA interactions, this guide equips readers with the knowledge and strategies needed to avoid common pitfalls and achieve regulatory success. Whether you're a seasoned developer or new to the field, this comprehensive guide will help you navigate the regulatory landscape with confidence.
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.