Critical Assessment of Pharmaceutical ProcessesA Rationale for Changing the Synthetic Route
AstraZeneca, Process R&D, Avlon/Charnwood, Avlon Works, Severn Road, Hallen, Bristol BS10 7ZE, U.K., GlaxoSmithKline, Synthetic Chemistry, Old Powder Mills, Tonbridge, Kent TN11 9AN, U.K., and Pfizer, Chemical R&D, PGR&D, Ramsgate Road, Sandwich, Kent CT13 9NJ, U.K.
Chem. Rev., 2006, 106 (7), pp 3002–3027
DOI: 10.1021/cr050982w
Publication Date (Web): March 8, 2006
Table of Contents
- 1. Introduction
- 2. Criteria for Process Assessment
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- 2.1. Safety Issues2.1.1. Potential Safety Issues and Their Significance
- 2.1.2. Prediction and Assessment of Safety Issues
- 2.1.3. Options To Manage Safety Issues
- 2.1.4. Designing a Safer New Route
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- 2.2. Environmental Issues
- 2.2.1. Potential Environmental Issues and Their Significance
- 2.2.2. Prediction and Assessment of Environmental Issues
- 2.2.3. Options To Manage Environmental Issues
- 2.2.4. Designing a New “Greener” Route
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- 2.3. Legal Issues
- 2.3.1. Potential Legal Issues and Their Significance
- 2.3.2. Prediction and Assessment of Legal Issues Associated with Regulated Substances
- 2.3.3. Prediction and Assessment of Legal Issues Associated with Patent Infringement
- 2.3.4. Options To Manage Patent Issues
- 2.3.5. Designing a New Route with Freedom To Operate
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- 2.4. Economic Issues
- 2.4.1. Potential Economic Issues and Their Significance
- 2.4.2. Prediction and Assessment of Economic Issues
- 2.4.3. Options To Manage Economic Issues
- 2.4.4. Designing a Cost-Effective New Route
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- 2.5. Control Issues
- 2.5.1. Potential Control Issues and Their Significance
- 2.5.2. Prediction and Assessment of Control Issues
- 2.5.3. Options To Manage Control Issues
- 2.5.4. Designing a New Route with Adequate Control Measures
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- 2.6. Throughput Issues
- 2.6.1. Potential Throughput Issues and Their Significance
- 2.6.2. Prediction and Assessment of Throughput Issues
- 2.6.3. Options To Manage Throughput Issues
- 2.6.4. Designing a New Route with High Throughput
- 3. Interrelationships between Process Issues
- 4. Conclusions
- 5. Acknowledgments
- 6. References
Filed under: PROCESS, Promising clips Tagged: Critical Assessment, Pharmaceutical Processes, Rationale for Changing, Synthetic Route