Approved: The Life Cycle of Drug Development / edited by Narendra Chirmule, Vihang Vivek Ghalsasi.

Format:

Book

Contributor:

Chirmule, Narendra, Editor.

Ghalsasi, Vihang Vivek., Editor.

Series:

Biomedical and Life Sciences Series

Language:

English

Subjects (All):

Pharmacology.

Drug delivery systems.

Toxicology.

Drug Delivery.

Local Subjects:

Pharmacology.

Drug Delivery.

Toxicology.

Physical Description:

1 online resource (XXVII, 634 p. 126 illus., 123 illus. in color.)

Edition:

1st ed. 2025.

Place of Publication:

Cham : Springer Nature Switzerland : Imprint: Springer, 2025.

Summary:

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.

Contents:

Foreword 1

Foreword 2

Life Cycle of Drug Development

Vaccines as prophylactics and therapeutics

Discovery of Biologic Drugs: past, present, and future

Cellular Therapies: from a theoretical concept to an immuno-augmented reality

Hope Unlocked: Gene therapies with viral vectors and Gene Editing

Process development for biologic therapeutics

Manufacturing of biologic therapeutics

Pharmacology of protein based therapeutics

The role of biomarkers in clinical development and its relevance in precision medicines

Examining the Toxicological Landscape of New Molecular Entities and Biotherapeutics

Perspective on Clinical Trials: What Researchers need to know

From Orphan Drugs to Inclusive Research: Bridging Global Gaps in Rare Disease Treatment

N=1: development pipeline for rare diseases

What Entrepreneurs Need to Know About Intellectual Property When Building a Strong Patent Portfolio

The power of Data Analytics: manufacturing Quality & Compliance

Quality Risk Analysis – the key to failure prevention

Regulatory Strategy

Epilogue

APPENDIX.

Notes:

Description based on publisher supplied metadata and other sources.

ISBN:

3-031-81787-7

OCLC:

1524420895