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Critical Assessment of Pharmaceutical Processes, A Rationale for Changing the Synthetic Route

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Changing the Synthetic Route - Chemical Reviews  ACS Publications -    --

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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

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