Navigating ANDA

Navigating ANDA

Dr. Nilesh Panchal

45,27 €
IVA incluido
Disponible
Editorial:
Draft2Digital
Año de edición:
2024
ISBN:
9798227382818
45,27 €
IVA incluido
Disponible
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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.

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