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Drug Discovery in Japan: Investigating the Sources of Innovation
Paperback
Business GeneralGeneral ScienceJapanese History
ISBN13: 9789811389085
Publisher: Springer
Published: Nov 6 2020
Pages: 333
Weight: 1.09
Height: 0.73 Width: 6.14 Depth: 9.21
Language: English
Foreword
Acknowledgement
Chapter 1: Introduction
1.1 Objectives
1.2 Drugs discussed in the case studies
References
Chapter 2: Compactin
The discovery of statin, penicillin for cholesterol
Abstract
2.1 Introduction
2.2 Timeline of the discovery and development of compactin
2.3 Statin discovery program
2.4 Novelty of the Endo's discovery program
2.5 Collaboration with academia
Box 2.1 Academic-industrial collaboration to understand the mechanism of action of statin
2.6 Crises and discontinuations
2.6.1 First crisis: failure in rats
2.6.2 Second crisis: suspected hepatotoxicity
2.6.3 Third crisis: discontinuation of clinical development
2.7 Science sources that supported the discovery of compactin
2.8 Responses to discontinuation of the clinical trial
2.9 Invisible discovery competition
2.10 Compactin is the basis for all statins
2.11 Statin sales
2.12 Conclusion
References
Chapter 3: Pravastatin (Pravachol, Mevalotin) Blockbuster statin discovered from the metabolites of compactin
Abstract
3.1 Introduction
3.2 Characteristics of pravastatin
3.3 Timeline of R&D for pravastatin
3.4 Discovery of pravastatin: from the metabolites of compactin
3.5 Pre-clinical studies using WHHL rabbits
3.6 Development of a two-step fermentation production process
3.7 Five yeas from initiating clinical trials to the approval for human use
3.10 Global large-scale and long-term clinical studies
3.12 Clinical development through collaboration between industry and academia
3.11 Toward a blockbuster drug
3.12 Partnership with Bristol-Myers Squibb
Box 3.1 Statin development competition: Sankyo vs Merck3.13 Conclusion
References
Chapter 4: Rosuvastatin(Crestor) Super statin which became a global block buster despite its late entry
Abstract
4.1 Introduction
4.2 Timeline of rosuvastatin synthesis and development
4.3 Discontinuation of the Clinical Trial by Shionogi4.4 AstraZeneca resumed clinical trials
4.5 Sources of discovery: fluvastatin as the lead compound
4.6 Crestor sales: Peak sales exceed 7.1 billion USD
4.7 Rosuvastatin vs atorvastatin
4.8 Properties of commercially available statins
4.9 Economic value of follow-on innovation
Box 4.11 different editions
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