Approved: The Life Cycle of Drug Development



de

,

Éditeur :

Springer


Paru le : 2025-04-29



eBook Téléchargement , DRM LCP 🛈 DRM Adobe 🛈
Lecture en ligne (streaming)
200,44

Téléchargement immédiat
Dès validation de votre commande
Ajouter à ma liste d'envies
Image Louise Reader présentation

Louise Reader

Lisez ce titre sur l'application Louise Reader.

Description

Drug development stands at a transformative threshold in modern medicine. Over the past three decades, biotherapeutics have redefined medical innovation, paving the way for treatments that are not only effective but also accessible. This book provides a comprehensive exploration of the intricate world of drug development, shedding light on the essential balance between efficiency, regulatory compliance, and quality to achieve both innovation and affordability.
 
Written by leading experts, this guide delves into the multi-faceted process of drug development, covering critical areas such as pharmacology, biomarkers, toxicology, product development, manufacturing, and clinical trials—all framed within the stringent requirements set by the FDA. Readers will find in-depth discussions on the latest technologies, statistical approaches, and quality assurance measures essential to navigating today’s complex regulatory landscape.
 
With practical case studies, project reports, and curated article reviews, this book offers valuable insights into risk assessment and mitigation at every stage of development. It serves as an indispensable resource for students, educators, and industry professionals, aiming to foster a deeper understanding of the challenges and opportunities in drug development and to inspire the next generation of scientific innovators.
Pages
634 pages
Collection
n.c
Parution
2025-04-29
Marque
Springer
EAN papier
9783031817861
EAN PDF
9783031817878

Informations sur l'ebook
Nombre pages copiables
6
Nombre pages imprimables
63
Taille du fichier
38994 Ko
Prix
200,44 €
EAN EPUB
9783031817878

Informations sur l'ebook
Nombre pages copiables
6
Nombre pages imprimables
63
Taille du fichier
53883 Ko
Prix
200,44 €

Dr. Narendra Chirmule has over three decades of experience in  drug development. He has held senior leadership positions at Biocon (Bangalore, India), Amgen (Thousand Oaks, CA) and Merck (Philadelphia, PA) . He is an expert in the area of immune responses to biologics and vaccines. Dr. Chirmule has a Ph.D. from University of Mumbai, post-doctoral training at Cornell University Medical College, New York, and teaching and research experience University of Pennsylvania.

 

Dr. Vihang Vivek Ghalsasi is a molecular biologist and science educator. With over nine years of industry and academic experience, including roles at Syngene International (Bangalore, India) and Shoolini University (Solan, Himachal Pradesh, India), he is also a BELS-certified copy-editor who supports researchers in scientific writing. Dr. Ghalsasi holds a PhD in molecular biology from Heidelberg University, Germany, and master’s in biotechnology from Indian Institute of Technology Bombay. He is a passionate explorer, travel blogger, and science communicator.

Suggestions personnalisées