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Dr. Miller's Publications, Books and Book Chapters


2020. Miller, M.J. Rapid Methods, in Cosmetic Microbiology, in Cosmetic Microbiology, Third Edition. Edited by Philip A. Geis. CRC Press, Taylor & Francis Group, LLC.

2019. Miller, M.J. Rapid Microbiological Methods, in Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing. Edited by David Roesti and Marcel Goverde. John Wiley & Sons, Inc.

2017. Miller, M.J. A Comprehensive Review of the Revised European Pharmacopoeia Chapter 5.1.6. Part 2. European Pharmaceutical Review. 22(6): 27-30.

2017. Miller, M.J. A Comprehensive Review of the Revised European Pharmacopoeia Chapter 5.1.6. Part 1. European Pharmaceutical Review. 22(5): 20-24.

2017. Miller, M.J. The Regulatory Acceptance of Rapid Microbiological Methods. European Pharmaceutical Review. 22(3): 55-58.

2017. Miller, M.J. The Role of Rapid Microbiological Methods in Aseptic Processing, in Aseptic and Sterile Processing, Control, Compliance and Future Trends. Edited by Tim Sandle and Edward C. Tidswell. PDA and DHI Publishing, LLC.

2016. Miller, M.J., van den Heuvel, E.R., Roesti, D. The Role of Statistical Analysis in Validating Rapid Microbiological Methods. European Pharmaceutical Review. 21(6): 46-53.

2015. Miller, M.J. Rapid Methods Update: Revisions to a United States Pharmacopeia Chapter. European Pharmaceutical Review. 20(4): 38-43.

2015. Miller, M.J. A Fresh Look at USP <1223> Validation of Alternative Microbiological Methods and How the Revised Chapter Compares with PDA TR33 and the Proposed Revision to Ph. Eur. 5.1.6. American Pharmaceutical Review. 18(5): 22-35.

2014. Miller, M.J. Rapid Microbiological Methods and the Regulatory Environment. European Pharmaceutical Review. 19(5): 24-27.

2013. Miller, M.J. Rapid Microbiology and the Newly Revised PDA Technical Report No. 33. American Pharmaceutical Review. 16(7): 34-38.

2013. Miller, M.J., Ragheb, S.M. Towards the Real Application of Rapid Microbiological Methods in developing Countries. European Pharmaceutical Review. 18(5): 13-16.

2013. Miller, M.J. An Introduction to Rapid Microbiological Methods: Regulatory Acceptance, Validation and Implementation. BioPharma Asia. 2(3): 28-33.

2013. Miller, M.J. The Encyclopedia of Rapid Microbiological Methods: The New Fourth Volume Discusses Technologies, Regulatory Acceptance and Validation Case Studies. European Pharmaceutical Review. 18(3): 11-13.

2013. Miller, M.J. Framework for Fast Microbiological Assessment. Pharmaceutical Manufacturing. 12(3): 39-41.

2013. Miller, M.J. Looking to the Future: Rapid and Automated Microbial Identification Technologies, in Encyclopedia of Rapid Microbiological Methods, Volume 4. Edited by Michael J. Miller. PDA and Davis Healthcare International Publishing.

2013. Miller, M.J.; Walsh, M.R.; Shrake, J.L.; Dukes, R.E.; Hill, D.B. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part II: Case studies in environmental monitoring during aseptic filling, intervention assessments and glove integrity testing in manufacturing isolators, in Encyclopedia of Rapid Microbiological Methods, Volume 4. Edited by Michael J. Miller. PDA and Davis Healthcare International Publishing.

2013. Miller, M.J.; Lindsay, H.; Valverde-Ventura, R.; O’Connor, M.J. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part I: Review of the technology and comparative studies with conventional methods., in Encyclopedia of Rapid Microbiological Methods, Volume 4. Edited by Michael J. Miller. PDA and Davis Healthcare International Publishing.

2013. Encyclopedia of Rapid Microbiological Methods, Volume 4. Edited by Michael J. Miller. PDA and Davis Healthcare International Publishing.

2013. Miller, M.J., Fragoeiro, S., Ramachandran, A., van Empel, P.: Improving the Quantitation of Live Antigens Used to Produce Rabbit Generated Serotype Specific Aniserum. European Pharmaceutical Review. 18(1): 55-57.

2012. Miller, M.J.: Hot Topics in Rapid Methods: Revisions to Validation Guidance and Real-Time Environmental Monitoring. European Pharmaceutical Review. 17(6): 58-61.

2012. Miller, M.J. Looking to the Future: Rapid and Automated Microbial Identification Technologies, in Microbial Identification. The Keys to a Successful Program. Edited by Mary Griffin and Dona Reber, PDA and Davis Healthcare International Publishing. Chapter 15: 1-29.

2012. Miller, M.J.; Miyashita, N. Rapid Micro Methods and the Next Generation in ATP Bioluminescence. European Pharmaceutical Review. 17(5): 14-16.

2012. Miller, M.J. Opportunities for Rapid Methods Discussions: Where the Experts are Meeting! European Pharmaceutical Review. 17(4): 11-13.

2012. Miller, M.J. Rapid Sterility Testing and the Impact of Recent Changes to the US Code of Federal Regulations. European Pharmaceutical Review. 17(3): 65-67.

2012. Miller, M.J. Rapid Micro Methods and EMA’s Post Approval Change Management Protocol. European Pharmaceutical Review. 17(2): 65-67.

2012. Miller, M.J. Case Study of a New Growth-Based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count. American Pharmaceutical Review. 15(2): 18-25.

2012. Miller, M.J. Rapid Micro Methods: New Year, Old Challenges! European Pharmaceutical Review. 17(1): 8-11.

2011. Miller, M.J. Detection of Microorganisms Using Micro-Electro-Mechanical Systems (MEMS). European Pharmaceutical Review. 16(6): 7-10.

2011. Miller, M.J. Detection of Microorganisms Using Micro-Electro-Mechanical Systems (MEMS). European Pharmaceutical Review. 16(5): 62-65.

2011. Miller, M.J. Detection of Microorganisms Using Optical Spectroscopic-Based Rapid Method Technologies. European Pharmaceutical Review. 16(4): 40-42.

2011. Miller, M.J. Detection of Microorganisms Using Cellular Component-Based Rapid Method Technologies. European Pharmaceutical Review. 16(3): 8-10.

2011. Miller, M.J. QbD, PAT, and the Future of Microbiology. Environmental monitoring with RMM. Contract Pharma. 13(4): 70-73.

2011. Miller, M.J. Direct Detection of Microorganisms Using Viability-Based Technologies. European Pharmaceutical Review. 16(2): 14-15.

2011. Miller, M.J. Rapid Microbiological Methods 2011. A Review of Growth-Based Technologies. European Pharmaceutical Review. 16(1): 38-41.

2011. Miller, M.J. Microbiology Series. Rapid Microbiological Methods 2011. European Pharmaceutical Review. 16 (1), 38-41.

2010. Miller, M.J. Microbiology Series. Article 6: The Implementation of Rapid Microbiological Methods. European Pharmaceutical Review. 15 (6), 27-31.

2010. Miller, M.J. Microbiology Series. Article 5: The Implementation of Rapid Microbiological Methods. European Pharmaceutical Review. 15 (5), 9-11.

2010. Miller, M.J. The Implementation of Rapid Microbiological Methods, in Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices. Edited by Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell, Business Horizons.

2010. Miller, M.J. Microbiology Series. Article 4: The Implementation of Rapid Microbiological Methods (EMA Perspectives). European Pharmaceutical Review. 15(4): 17-19.

2010. Miller, M.J. Microbiology Series. Article 3: The Implementation of Rapid Microbiological Methods (FDA Perspectives). European Pharmaceutical Review. 15(3), 18-21.

2010. Miller, M.J. Developing a validation strategy for rapid microbiological methods. American Pharmaceutical Review. 13 (3), 28-33.

2010. Miller, M.J. Microbiology Series. Article 2: The Implementation of Rapid Microbiological Methods (Method Validation). European Pharmaceutical Review. 15(2), 24-26.

2010. Miller, M.J. Microbiology Series. Article 1: The Implementation of Rapid Microbiological Methods (Overview of RMMs). European Pharmaceutical Review. 15(1), 39-41.

2010. Miller, M.J.; Moldenhauer, J. Revision of PDA Technical Report Number 33. American Pharmaceutical Review. 13 (1), 86-91.

2009. Miller, M.J. Breaking the rapid microbiological method financial barrier: A case study in RMM return on investment and economic justification. BioPharm International. 22 (9), 44-53.

2009. Miller, M.J. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles, in Environmental Monitoring, Volume 3. Edited by Jeanne Moldenhauer, PDA and Davis Healthcare International Publishing. 269-288.

2009. Miller, M.J. Rapid microbiological methods and demonstrating a return on investment: It's Easier than you think! American Pharmaceutical Review. 12 (5), 42-47.

2009. Miller, M.J. Real-time environmental monitoring: PAT solutions using rapid microbiological methods. European Pharmaceutical Review. 14 (4), 40-46.

2009. Miller, M.J. Ensuring ROI from your RMM. Pharmaceutical Manufacturing. 8 (6), 32-35.

2009. Miller, M.J.; Lindsay, H.; Valverde-Ventura, R.; O'Connor, M.J. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part I: Review of the technology and comparative studies with conventional methods. PDA J. Pharm. Sci. Technol. 63 (3), 244-257.

2009. Miller, M.J.; Walsh, M.R.; Shrake, J.L.; Dukes, R.E.; Hill, D.B. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part II: Case studies in environmental monitoring during aseptic filling, intervention assessments and glove integrity testing in manufacturing isolators. PDA J. Pharm. Sci. Technol. 63 (3), 258-282.

2009. Miller, M.J. Quality Risk Management and the Economics of Implementing Rapid Microbiological Methods. European Pharmaceutical Review. April; 2: 66-73.

2009. Miller, M.J. It's Time to Get Rapid!. PDA Letter. April; 45(4): 1-21.

2009. Miller, M.J. Rapid Microbiological Methods in Support of Aseptic Processing, in Practical Aseptic Processing: Fill and Finish. Edited by Jack Lysfjord, PDA and Davis Healthcare International Publishing.

2008. Miller, M.J. Rapid Microbiological Methods, in Microbiology in Pharmaceutical Manufacturing, 2nd Edition. Edited by Richard Prince, PDA and Davis Healthcare International Publishing.

2008. Miller, M.J.; Claerbout, M.E.; DeMaio, R.A.; et al. Microbiological Control Strategies during the Development of Pharmaceutical Products and Processes, in Microbiology in Pharmaceutical Manufacturing, 2nd Edition. Edited by Richard Prince, PDA and Davis Healthcare International Publishing.

2006. Miller, M.J. Rapid Microbiological Methods for a New Generation. Pharmaceutical Manufacturing. February 2006; 5(2): 14-23.

2005. Foreword, Encyclopedia of Rapid Microbiological Methods, Volumes 1-3. Edited by Michael J. Miller, PDA and Davis Healthcare International Publishing.

2005. Miller, M.J. The Impact of Process Analytical Technology (PAT), cGMPs for the 21st Century and Other Regulatory and Compendial Initiatives on the Implementation of Rapid Microbiological Methods, in Encyclopedia of Rapid Microbiological Methods, Volume 1. Edited by Michael J. Miller, PDA and Davis Healthcare International Publishing.

2005. Miller, M.J. Rapid Microbiological Methods and FDA's Initiatives for Process Analytical Technology and Pharmaceutical cGMPs for the 21st Century: A Risk Based-Approach. American Pharmaceutical Review. January/February 2005; 8(1): 104-107.

2003. Reich, R.; Miller, M.; Patterson, H. Developing a viable environmental monitoring program for nonsterile pharmaceutical operations. Pharmaceutical Technology. March 2003.

2002. Tchao, R.; McCanna, D.; Miller, M.J. Comparison of contact lens multi-purpose solutions by an in vitro sodium fluorescein permeability assay. CLAO J. 28: 151-156.

2001. Miller, M.J.; Emerson, R. Auditing the Pharmaceutical Microbiology Laboratory, in Microbiology in Pharmaceutical Manufacturing. Edited by Richard Prince, Davis Horwood International Publishing, Limited. Pages 647-686.

2001. Miller, M.J.; Callahan, D.E.; McGrath, D.; et al. Disinfection Efficacy of Contact Lens Care Solutions against Ocular Pathogens. CLAO J. 27: 16-22.

2000. Miller, M.J.; Manchester, R.J.; Callahan, D. Antimicrobial activity of ReNu MultiPlus against Pseudomonas. Contact Lens Spectrum. 15: 23-30.

2000. Miller, M.J.; Manchester, R.J.; Callahan, D. Setting the record straight on ReNu MultiPlus solution. Optician. 219: 40-42.

1999. Lever, A.M.; Miller, M.J. Comparative antimicrobial efficacy of multi-purpose lens care solutions using the FDA's revised guidance document for industry. CLAO J. 25: 52-56.

1995. Miller, M.J. Contact lens disinfectants. In Handbook of Disinfectants and Antiseptics, edited by J. Ascenzi. Marcel Dekker, Inc., New York, pp. 83-110.

1991. Miller, M.J.; Wilson, L.A.; Ahearn, D.G. Adherence of Pseudomonas aeruginosa to rigid gas-permeable contact lenses. Arch. Ophthalmol. 109: 1447-1448.

1990. Meridith, T.A.; Aguilar, H.E.; Miller, M.J.; et al. Comparative treatment of experimental Staphylococcus epidermidis endophthalmitis. Arch. Ophthalmol. 108: 857-860.

1990. Meridith, T.A.; Trabelsi, A.; Miller, M.J.; et al. Spontaneous sterilization in experimental Staphylococcus epidermidis endophthalmitis. Invest. Ophthalmol. Vis. Sci. 31: 181-186.

1988. Ward, M.A.; Miller; M.J. The microbiology of contact lens wear. Contact Lens Forum. 13(2): 25-29.

1988. Miller, M.J.; Wilson, L.A.; Ahearn, D.G. Effects of protein, mucin, and human tears on adherence of Pseudomonas aeruginosa to hydrophilic contact lenses. J. Clin. Microbiol. 26: 513-517.

1987. Miller, M.J.; Ahearn, D.G. Adherence of Pseudomonas aeruginosa to hydrophilic contact lenses and other substrata. J. Clin. Microbiol. 25: 1392-1397.

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