Approved: The Life Cycle of Drug Development
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 wor...
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| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Lenguaje: | inglés |
| Publicado: |
Cham :
Springer Nature Switzerland : Imprint: Springer,
2025.
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| Edición: | 1st ed. 2025. |
| Materias: | |
| Acceso en línea: | https://doi.org/10.1007/978-3-031-81787-8 |
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Tabla de Contenidos:
- 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.