Approved: The Life Cycle of Drug Development

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.

• Erscheinungsdatum: 29.04.2025
• Autor/Autorin: Narendra Chirmule
• Reihe: Biomedical and Life Sciences (R0)
• Format: E-Book
• Dateiformat: PDF
• Kopierschutz: Wasserzeichen
• Dateigröße: 38.1 MB
• Verlag: SPRINGER
• Sprache: Englisch
• Umfang: 634 Seiten
• ISBN: 9783031817878
• Lieferung: Sofort per Download
• Hinweis: Sofort per Download lieferbar. Kein physischer Versand.
• Kompatibilität: Lesbar auf Geräten und Apps mit PDF-Unterstützung.