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Books

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  1. M.W. Dong, HPLC and UHPLC for Practicing Scientists, 2nd Ed., Wiley, Hoboken, New Jersey, 2019. Available from Amazon.com or Wiley as E-Book or Paperback.

  2. M.W. Dong, Modern HPLC for Practicing Scientists, Wiley, Hoboken, New Jersey, 2006 (A best seller in HPLC with 8000 copies sold)

  3. Handbook of Pharmaceutical Analysis by HPLC, S. Ahuja and M.W. Dong (Eds), Elsevier/Academic Press, Amsterdam, the Netherlands, 2005.   

  4. J.L. DiCesare, M.W. Dong, and L. S. Ettre. Introduction to High-Speed Liquid Chromatography, Perkin-Elmer, Norwalk, CT, 1981.

  5. D. Guillarme and M. W. Dong (Eds). UHPLC: Where we are ten years after its commercial introduction, Trends in Anal. Chem., 63, 1-188, 2014 (Special issue).

  6. M.W. Dong, My Career as a Separation Scientist, KDP, 2021. (Print and eBook, Chinese version available as eBook),

2019, 2nd Ed.
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Technical Papers
 

130+ publications (>100 as first author). Selected titles are shown here. Download papers with underlined links for pdf files. Please do not share without permission from the author. Most popular articles in Red. Coauthors' organizations listed on right.

 

Stability Studies and Testing (A series of 3 white papers)

  1. K. Huynh-Ba and M. W. Dong, Stability Studies and Testing of Pharmaceuticals: An Overview, LCGC North Am. 38(6), 325-336, 2020.
     

  2. M. W. Dong, K. Huynh-Ba, and J. T. Ayers, Development of Stability-Indicating Analytical Procedures by HPLC: An Overview and Best Practices, LCGC North Am. 38(8), 440-455, 2020.
     

  3. K. Huynh-Ba, A. Wong,  and M. W. Dong, Validation of Stability-Indicating HPLC Methods for Pharmaceuticals: Overview, Methodologies and Case Studies, LCGC North Am. 38(101, 606-618, 2020.


 

Separation Science in Drug Development (A series of 4 white papers)

 

  1. M. Wong, B. Murphy, J. H. Pease and M. W. Dong, Separation Science in Drug Development, Part 1: High –Throughput Purification. LCGC North Am. 33(6), 402-413, 2015.
     

  2. B. Lin, J. H. Pease and M. W. Dong, Separation Science in Drug Development, Part 2: High –Throughput Characterization. LCGC North Am. 33(8), 534-545, 2015.
     

  3. M. W. Dong, Separation Science in Drug Development, Part 3: Analytical Development, LCGC North Am, 33(10), 764-775, 2015.
     

  4. D. Kou, L. Wigman, P. Yehl and M. W. Dong, Separation Science in Drug Development, Part 4: Quality Control, LCGC North Am. 33(12), 900-909, 2015.

 

UHPLC (A series of 3 white papers)
 

  1. M.W. Dong, UHPLC 1: Perspectives and Instrumental Features, LCGC North Amer. 35(6), 374-381, 2017.
     

  2. M.W. Dong and D. Guillarme, UHPLC 2: Benefits, LCGC North Amer. 35(8), 486-495, 2017.
     

  3. M.W. Dong, UHPLC 3: Potential Issues, LCGC North Amer. 35(11), 818-823, 2017.
     

HPLC Instruments (A series of 4 white papers)
 

  1. K. Shoykhet, K. Broeckhoven, and M.W. Dong, Modern HPLC Pumps: Perspectives, Principles, and Practice, LCGC North Amer. 37(6), 374-384, 2019.
     

  2. C. Paul, F. Steiner and M.W. Dong, HPLC Autosamplers: Perspectives, Principles, and Practices, LCGC North Amer. 37(8), 514-529, 2019.
     

  3.  M.W. Dong and J. Wysocki, Ultraviolet detectors: Perspectives, Principles, and Practices, LCGC North Amer. 37(10), 750-759, 2019.
     

  4. R. Mazzarese, S. M. Bird, M.W. Dong, Chromatography Data Systems: Perspective, Principles and Trends, LCGC North Amer. 37(12), 852-866, 2019.
     

  5. M. W. Dong, New HPLC Systems and Related Products Introduced in 2018-2019: A Brief Review, LCGC North Am, 37(4), 252-259, 2019. (Same series from 2013-2020).(Seven installments total)
     

HPLC Method Development

 

  1. M.W. Dong, A Three-Pronged Template Approach for Rapid HPLC Method Development. LCGC North Am. 31(8), 612-621, 2013.
     

  2. M. W. Dong, A Universal Reversed-Phase HPLC Method for Pharmaceutical Analysis, LCGC North Am, 34(6), 408-419, 2016.
     

  3. M. W. Dong, D. Guillarme, S. Fekete, R. Rangelova, J. Richards, D. Prudhomme, and N. P. Chetwyn. High-resolution separations of complex pharmaceuticals by UHPLC: Case studies and quality control implications, LC GC North Am. 32(11), 868-76, 2014.
     

  4. M. W. Dong and K. Zhang, UHPLC in method development, Trend in Anal. Chem., 63, 21-30, 2014.(Not Available from here).
     

Bioscience
 

  1. R. E. Moore, K. Broster, K. Cook, K. D’Silva, E. Niederkofler, A.O. Bailey, J. Bones, and M. W. Dong. Antibody-Drug Conjugates: Perspectives and Characterization. LCGC North Am. 36(6), 362-274, 2018.
     

  2. T. Zhang, C. Quan and M.W. Dong, HPLC for Characterization and Quality Control of Therapeutic Monoclonal Antibodies. LCGC North Am. 32(10), 796-808, 2014.

Drug Development and Regulations (A series of 9 papers, 2022-2024, New)​

  1. M. W. Dong, The Pharmaceutical Industry and the Separation Scientist: Perspective, Trends, and Career Opportunities, LCGC North Am.  40 (6), 252-257, 2022.
     

  2. M. W. Dong, Small Molecule Drug Discovery (SMDD): Processes, Perspectives, Candidate Selection, and Career Opportunities for Analytical Chemists, LCGC North Am.  40 (8), 344-350, 2022.
     

  3. M. W. Dong, Drug Development Process: Nonclinical Development of Small Molecule Drugs, LCGC North Am.  40 (10), 484-492, 2022.
     

  4. L. Doneski and M. W. Dong, Pharmaceutical Regulations: An Overview for the Analytical Chemist, LCGC North Am.  41 (6), 211-215, 2023.
     

  5. L. Doneski, D. Roos, and M. W. Dong, Good Laboratory Practice (GLP): An Overview for the Analytical Chemist, LCGC North Am.  41 (10), xxx, 2023.
     

  6. L. Doneski and M. W. Dong, Good Manufacture Practice (cGMP): An Overview for the Analytical Chemist, LCGC North Am.  41 (11), xxx, 2023.
     

Others

  1. M. W. Dong and B. E. Boyes, Modern Trends and Best Practices in Mobile-Phase Selection in Reversed-Phase Chromatography, LCGC North Am, 36(10), 752-767, 2018.
     

  2. M. W. Dong, Ten Common-Sense Corollaries in Pharmaceutical Analysis by HPLC, LCGC North Am, 36(8), 506-509, 2018.
     

  3. M. W. Dong and R. M. Woods, Quality Control Methodologies for Pharmaceutical Counterions, LCGC North Am, 34(10), 792-797, 2016.
     

  4. M. W. Dong, HPLC Column Standardization in Pharmaceutical Development: A Case Study, LCGC North Am, 34(8), 540-545, 2016.
     

  5. M.W. Dong, Seven Common Faux Pas in Modern HPLC. LCGC North Am. 32(8), 552-557, 2014.
     

  6. D. Guillarme and M. W. Dong. Newer developments in HPLC impacting pharmaceutical analysis: A brief review, Amer. Pharm. Rev. 16(4), 36-43, 2013.
     

  7. S. Fekete, D. Guillarme, and M.W. Dong, Superficially Porous Particles: Perspectives, Practices, and Trends. LCGC North Am. 32(6), 420-433, 2014.
     

  8. M.W. Dong, Myths in UHPLC. LCGC North Am. 31(10), 868-880, 2013.
     

  9. L. Dai, A. C. Quiroga, K. Zhang, H. B. Runes, D.T. Yazzie, K. Mistry, N. P. Chetwyn and M. W. Dong*, A Generic Headspace GC Method for Residual Solvents in Pharmaceuticals: Benefits, Rationale, and Adaptations for New Chemical Entities, LC.GC, 28(1), 54-66, 2010.
     

Regulatory Filings

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  1. Authored CMC sections of IND or IMPD of several new chemical entities for oncology (AKT-0068 (Phase 0 to 2b), IAP-0152 and IAP-0917)
     

  2. Contributed CMC filing to NDA/BLA (OxyContin NDA amendments and BLA for Kadcyla T-DM1 antibody-drug conjugate).

Patents and Research Grants

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  1. U.S. Patent - Apparatus for periodically monitoring of a plurality of samples (dissolution testing).
     

  2. NIH Research Grant - "Occurrence, tumorigenicity, and metabolism of quinolines."

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