Managing the Drug Discovery Process: Insights and advice for students, educators, and practitioners
Autor Susan Miller, Walter Moos, Barbara Munk, Stephen Munk, Charles Hart, David Spellmeyeren Limba Engleză Paperback – 13 mar 2023
This new edition takes a closer look at the challenges and opportunities for new medicines and examines not only the current research milieu that will deliver novel therapies, but also how the latest discoveries can be deployed to ensure a robust healthcare and pharmacoeconomic future. All chapters have been revised and expanded with new discussions on remarkable advances including CRISPR and the latest gene therapies, RNA-based technologies being deployed as vaccines as well as therapeutics, checkpoint inhibitors and CAR-T approaches that cure cancer, diagnostics and medical devices, entrepreneurship, and AI. Written in an engaging manner and including memorable insights, this book is aimed at anyone interested in helping to save countless more lives through science. A valuable and compelling resource, this is a must-read for all students, educators, practitioners, and researchers at large—indeed, anyone who touches this critical sphere of global impact—in and around academia and the biotechnology/pharmaceutical industry.
- Considers drug discovery in multiple R&D venues - big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes - with a clear description of the degrees and training that will prepare students well for a career in this arena
- Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work
- Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable
- Addresses new areas such as CRISPR gene editing technologies and RNA-based drugs and vaccines, personalized medicine and ethical and moral issues, AI/machine learning and other in silico approaches, as well as completely updating all chapters
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Specificații
ISBN-13: 9780128243046
ISBN-10: 012824304X
Pagini: 682
Ilustrații: 210 illustrations (90 in full color)
Dimensiuni: 216 x 276 x 35 mm
Greutate: 1.56 kg
Ediția:2
Editura: ELSEVIER SCIENCE
ISBN-10: 012824304X
Pagini: 682
Ilustrații: 210 illustrations (90 in full color)
Dimensiuni: 216 x 276 x 35 mm
Greutate: 1.56 kg
Ediția:2
Editura: ELSEVIER SCIENCE
Public țintă
Primary: Those working in research and development; quality management; operational excellence; medical; quality assurance; production across the pharmaceutical, biopharmaceutical sectorsSecondary: Students at all levels who are contemplating a career in the biopharmaceutical industry, drug discovery and development scientists who early in their careers and those academics with an entrepreneurial interest in drug discovery and development.
Cuprins
Section A: Introduction and Overview
1. Backgrounder—Part 1
2. Backgrounder—Part 2
Section B: Preprofessional Education
3. Introduction: Preprofessional education
4. Two-year certification and degree programs
5. Four-year undergraduate degree programs
6. The big decision
Section C: Graduate and Professional Education
7. Graduate and postgraduate education at a crossroads
8. Master’s degree programs
9. Doctoral and professional programs
10. The big leap
Section D: Research and Discovery
11. Drug discovery: Standing on the shoulders of giants
12. Drug discovery processes: When and where the rubber meets the road
13. Drug discovery: Chaos can be your friend or your enemy
14. Research and discovery: Essential partners but just a start
Section E: Chemical, Biological, and Healthcare Product Development, Quality Requirements, and Regulatory Affairs
15. Turning a potent agent—a chemical "drug"—into a registered product
16. Chemical development: Synthetic studies and engineering including aspects of batch production and continuous processing
17. Chemical development: Analytical studies
18. FDA path and process: Sponsor’s regulatory tasks for drug approval
19. Development of biological and other healthcare products
Section F: Pharmaceutical Research and Development: Concluding Remarks
20. Epilogue
1. Backgrounder—Part 1
2. Backgrounder—Part 2
Section B: Preprofessional Education
3. Introduction: Preprofessional education
4. Two-year certification and degree programs
5. Four-year undergraduate degree programs
6. The big decision
Section C: Graduate and Professional Education
7. Graduate and postgraduate education at a crossroads
8. Master’s degree programs
9. Doctoral and professional programs
10. The big leap
Section D: Research and Discovery
11. Drug discovery: Standing on the shoulders of giants
12. Drug discovery processes: When and where the rubber meets the road
13. Drug discovery: Chaos can be your friend or your enemy
14. Research and discovery: Essential partners but just a start
Section E: Chemical, Biological, and Healthcare Product Development, Quality Requirements, and Regulatory Affairs
15. Turning a potent agent—a chemical "drug"—into a registered product
16. Chemical development: Synthetic studies and engineering including aspects of batch production and continuous processing
17. Chemical development: Analytical studies
18. FDA path and process: Sponsor’s regulatory tasks for drug approval
19. Development of biological and other healthcare products
Section F: Pharmaceutical Research and Development: Concluding Remarks
20. Epilogue
Recenzii
*4 stars* “…provides updated information on biotechnology- based research [and] the opportunities and challenges in developing novel drugs…. Most topics provide sufficient explanation of how a lead compound is developed and how it is assessed for its bioactivity and toxicity…. There are sufficient illustrations to help readers understand the key concepts... [A] well-written book [that] is useful for students, educators, and people interested in working in the pharmaceutical and biotechnology industry, especially in discovering and delivering novel therapeutics…. [A] must- have for future and current pharmaceutical biotechnology scientists.” --©Doody’s Review Service, 2023, Rahmat M. Talukder, PhD, RPh (The University of Texas at Tyler)