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Summary of Qualifications

  • Executive Director and Founder of Pharmalytik.
  • Expertise focuses in GMP/Compliance, Analytical Development, Method Development/Validation/Transfer, Stability and Outsourcing Project management.
  • Provides quality assessment and builds Quality Management Systems (QMS) for clients.
  • Provides consulting activities for pharmaceutical companies including those operating under Consent Decree.
  • Provides technical training for cGMP compliance and quality topics for national and international organizations such as ACS, AAPS, Pittburgh Conference, and many other international training groups.
  • Provides in-house cGMP and Stability training to several pharmaceutical companies in US, Brazil, Asia and India.
  • Adjunct Professor of Analytical Graduate Program of Illinois Institute of Technology in Chicago.
  • Adjunct Professor of QA/RA Graduate Program of Temple University, School of Pharmacy in Philadelphia.
  • Adjunct Professor of General Chemistry of Widener University.
  • Possesses over 25 years of experiences in various areas of pharmaceutical development working with Wyeth, DuPont Pharmaceuticals, Bristol-Myers Squibb, ICI Americas (currently Astra Zeneca).

Volunteer Activities

  • Serves in the Executive Committee of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President.
  • Serves as USP Council of Expert (2015-2020), Chair of Chemical Medicines IV Expert Committee.
  • Active member of ACS, AAPS, PSDG.
  • Serves as Chair of USP Good Documentation Practices Expert Panel and Member of USP Impurities Expert Panel.
  • Serves on the editorial board of AAPS Open Journal.
  • Served as Member of USP General Chapters Expert Committee – Physical Analysis (2010-2015), and member of USP Reference Standard Project Team and USP Prescription/Non-Prescription Stakeholder Forum of previous cycle.
  • Founder and Chair of the AAPS Stability Focus Group, Member of AAPS Publication committee, Steering Committee Member of the AAPS Pharmaceutical Impurities and CMC Focus Groups.

Awards

  • 2015 Recognition Award for AAPS Stability Testing 101 eLearning Course.
  • 2014 Recognition Award for AAPS Regulatory Sciences 101 eLearning Course.
  • 2013 EAS President Achievement.
  • 2013 Service Award from AAPS Regulatory Sciences (RS).
  • 2008 Service Award from AAPS Analysis and Pharmaceutical Quality (APQ).
  • 2008 Recognition Award from AAPS Regulatory Sciences.
  • 2001 Asian American Leadership Award from DuPont.

Books

  • Co-author “Introduction of Pharmaceutical Analysis”, to be published by John Wiley & Sons Publisher, expected 2016.
  • Editor of "Current Trends of Stability Testing To Support Global Markets", published by Springer Publisher & AAPS, 2010.
  • Editor of ""Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices", published by Springer Publisher, 2008.

Seminars

  1. “Regulatory Expectations on Method Validation for Drug Products”, K. Huynh-Ba, Strategies of Stability Testing Conference, LaJolla, CA, on July 26-27, 2007
  2. “Effects of Global Regulations and markets on Stability Program for Product Registration”, K. Huynh-Ba, IPC Canada, presented at Stability Testing Conference in Toronto, Canada, in October 2006.
  3. “Analytical Method Validation”, K. Huynh-Ba, IPC Canada, presented at Stability Testing Conference in Toronto, Canada, in October 2006.
  4. “SOP: Validation of Chromatographic Methods”, K. Huynh-Ba, International Validation Technology, presented at Laboratory Compliance Conference in Alexandria, Virginia, in August 2006.
  5. “Method Transfer for Analytical Test Methods”, K. Huynh-Ba, International Validation Technology, presented at Technology Transfer Conference in Philadelphia, PA in July 2006.
  6. “Key Factors in Method Transfer”, K. Huynh-Ba, International Validation Technology, presented at Tech Transfer Conference in Philadelphia, PA in July 2006.
  7. “Development of Global Stability Protocols”, K. Huynh-Ba, Center of Business Intelligence, presented at Stability Summit in Princeton, NJ, in June 2006.
  8. “Stability Method Development and Validation”, K. Huynh-Ba, International Validation Technology, presented at Stability Conference in Amsterdam, Netherlands, in November 2005.
  9. “Stability Data Record and Reports – A Balancing Act among Quality, Efficiency and Integrity”, K. Huynh-Ba, International Validation Technology, presented at Stability Conference in Amsterdam, Netherlands, in November 2005.
  10. “FDA Expectations on Method Validation for Mature Drug Products”, K. Huynh-Ba, International Validation Technology, presented at Laboratory Compliance Conference in Dublin, Ireland, in April 16, 2005.
  11. “Developing and Validating Stability Indicating Methods”, K. Huynh-Ba, International Validation Technology, presented at Laboratory Compliance Conference in Dublin, Ireland, in April 2005.
  12. “Validation of Chromatographic Methods for Pharmaceutical Products”, K. Huynh-Ba, International Validation Technology, presented at Laboratory Compliance Conference in Dublin, Ireland, in April 2005.
  13. “Record Stability Data in R&D Pharmaceutical Laboratories”, K. Huynh-Ba, Pharmaceutical Stability Testing Conference hosted by SWE International, LaJolla, March 7-8, 2005.
  14. “Developing Dissolution Methods of Comparator Products”, K. Huynh-Ba, presented at the AAPS Workshop on Dissolution: New Technologies and Regulatory Initiatives, sponsored by AAPS, CRS and USP in Bethesda, MD, March 29-31, 2004.
  15. “Analytical Data Management for Stability Testing in Pharmaceutical Laboratories”, K. Huynh-Ba, International Validation Technology, presented at the Laboratory Validation Conference in Philadelphia, PA, August 18-22, 2003.
  16. “Outsourcing Analytical Testing”, K. Huynh-Ba, International Validation Technology, presented at the Laboratory Validation Conference in Philadelphia, PA, August 18-22, 2003.
  17. “Record Analytical Data for Stability Testing in Pharmaceutical Laboratories”, K. Huynh-Ba, International Stability Program hosted by CBI International, presented in Philadelphia, PA, July 17-18, 2003.
  18. “Overview of Drug Development Process”, K. Huynh-Ba, 2001 Conference of Molecular Biology and Pharmacology, hosted by Vietnamese Association of Clinical Biochemists, Ho Chi Minh City, Vietnam, June 26-28, 2001.
  19. “Stability: ICH Guidelines on New Drug Application”, K. Huynh-Ba, 2001 Conference of Molecular Biology and Pharmacology, hosted by Vietnamese Association of Clinical Biochemists, Ho Chi Minh City, Vietnam, June 26-28, 2001.
  20. “Outsourcing a Stability Program: Building a Partnership”, K. Huynh-Ba, Global Stability Program 2001 hosted by IIR International, Philadelphia, PA, April 19, 2001, and International Stability Program 2001 hosted by CBI, Philadelphia, PA, June 15, 2001.
  21. “Record Analytical Data for Stability Testing in Pharmaceutical Laboratories”, K. Huynh-Ba, Stability Data Management Conference hosted by CBI International, Philadelphia, PA, January 29, 2001.
  22. “Developing Stability Strategies for Phase I, II and III”, K. Huynh-Ba, Global Stability Program 2000 hosted by IIR International, Philadelphia, PA, September 27, 2000.
  23. "Statistical Applications for Stability Data", K. Huynh-Ba and M. A. Gorko, DMPC Pharmaceutical R&D, Wilmington, DE, Ausgust 14, 1996.
  24. "Purity Evaluation of HPLC Acetonitrile Under Buffered and Non-Buffered Gradient Elution System -- Recovery and Clean-up Study of Aromatic Amine and Nitro Compounds From Soil Using Solid Phase Extraction", K. B. Cao and R. L. Grob, Villanova University, Villanova, PA , May 1989.
  25. "Evaluation of High Performance Liquid Chromatographic Solvents", K. B. Cao and R. L. Grob, Mid Atlantic Regional Meeting, Atlantic City, NJ, May 1987.


Publications

  • “Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape”, K Huynh-Ba et. al., AAPS PharmSci Tech, December 21, 2013.
  • “Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms”, K Huynh-Ba et. al., AAPS PharmSci Tech, November 27, 2013.
  • “2007 Highights of Advances in the Pharmaceutical Sciences: An AAPS perspective”, K. Huynh-Ba et. Al, The AAPS Journal, 9(2), June 22, 2007.
  • “Highlights of Current Drug Product Stability Issues, K. Huynh-Ba and E. Nelson, Pharmaceutical Technology, December 27, 2006.
  • “Analytical Development Stategies for Comparator Products”, K. Huynh-Ba and A. F. Aubry, American Pharmaceutical Review, Summer 2003 and American Pharmaceutical Outsourcing, Summer 2003.
  • “Application of The Zymark Multidose Automated Workstation: The Challenge of Dissolution Medium Containing Surfactant with the UV Spectroscopic Analysis”, I. Y. Ma, K. Huynh-Ba and J. J. Mullen, published in the Laboratory Robotics and Automation Journal in January 2001.
  • “From Laboratory Notebook to Laboratory Worksheets: Recording Analytical Data for Stability Testing of Pharmaceuticals”, K. Huynh-Ba and A.F. Aubry, Managing Modern Laboratory, Vol. 4, N. 4, June 2000 and American Laboratory, Vol.32, N.24, December 2000.
  • "Application of The Zymark Multidose Automated Workstation With Dissolution Medium Containing Surfactant", K. Huynh-Ba, I.Y. Ma and J. J. Mullen, International Symposium on Laboratory Automation and Robotics (ISLAR) proceedings, 1999.
  • "HPLC Study of The Recovery of Aromatic Amine and Nitro Compounds from Soil", K. B. Cao and R. L. Grob, J. of Env. Sci. and Health, Feb. 90.
  • "Evaluation of Purity Level of HPLC Solvents", K. B. Cao and R. L. Grob, J. of Env. Sci. and Health, Feb. 90.
  • "Acetonitrile-Phosphate Buffer System under Gradient Condition", K. B. Cao and R. L. Grob, J. of Env. Sci. and Health, Feb. 90
  • "Effect of Phosphate Buffer on Different C18 Stationary Phases in Gradient Separation", K. B. Cao and R. L. Grob, J. of Env. Sci. and Health, Feb. 90.

Courses

  • “Complying with FDA/ICH Requirements for Stability Testing”, K. Huynh-Ba, Pharmaceutical Training Institute (PTI), presented from 2002 to present in Philadelphia, Washington DC, Boston, New Brunswick, Chicago, San Francisco, North Carolina and San Diego.
  • “Stability Fundamentals of Drug Products and API”, K. Huynh-Ba & M. A. Gorko, Sunrise School session, 2006 AAPS annual meeting, San Antonio, Texas, 01 November 2006.
  • “Modern HPLC in Pharmaceutical Analysis”, K. Huynh-Ba & Michael Dong, ACS Spring Meeting, Atlanta, GA on 28-29 March 2006.
  • “Stability Regulations: Methodologies and Best Practices”, K. Huynh-Ba & Michael Dong, ACS Spring Meeting, Atlanta, GA on 28-29 March 2006.
  • "Stability Testing of Pharmaceutical Products: Fundamentals, Analytics and Regulations", K. Huynh-Ba, EAS annual meeting, Somerset, November 2006.
  • “Modern HPLC in Pharmaceutical Analysis”, K. Huynh-Ba & Michael Dong, EAS annual meeting, Somerset, November 2006.
  • Complying with CMC requirements”, K. Huynh-Ba & J. J. Chen, Pharmaceutical Training Institute (PTI), presented in 2003-2004 in Philadelphia, Washington DC, Boston, New Brunswick, Chicago, San Francisco, North Carolina and San Diego.
  • “Introduction to cGMP”, K. Huynh-Ba, presented in 2004-2005 in Somerset, New Jersey.

Posters

  1. "Optimization of Experimental Conditions for the Determination of Intrinsic Dissolution of a Poorly Water-Soluble Drug”, I. Y. Ma, V. Sharma, K. Huynh-Ba, A. Aubry and M. Xie, American Association of Pharmaceutical Scientists, Denver, CO, October 23, 2001.
  2. "Development of Dissolution Testing for Suspension Products", K. Huynh-Ba, I. Y. Ma, J. Q. Xu and V. A. Gray, American Association of Pharmaceutical Scientists, New Orleans, MI, November 14, 2000.
  3. "Automating Dissolution Testing of Efavirenz Tablets Using the Zymark Multidose Dissolution Testing System", K. Huynh-Ba, I.Y. Ma, J. J. Mullen and V. A. Gray, International Symposium on Laboratory Automation and Robotics, Boston, MA, October 19, 1999.
  4. "Determination of DPC 961 in Dissolution Samples of DPC 961 Tablets", K. Huynh-Ba, J. Q. Xu and V. A Gray, Eastern Analytical Symposium, Somerset, NJ, November 18, 1999.
  5. "Dissolution Condition Selection for DMP 777 Capsules", J. J. Mullen, V. A. Gray and K. Huynh-Ba, American Association of Pharmaceutical Scientists, New Orleans, MI, November 14, 1999.
  6. "Investigation of Photodegradation of formulated and non-formulated Non-Nucleoside Reverse Transcriptase Inhibitors", A. F. Aubry, D. Bindra, J. Q. Xu and K. Huynh-Ba, American Association of Pharmaceutical Scientists, New Orleans, MI, November 14, 1999.
  7. “Selection of Dissolution Media for DMP 777 Capsules”, J. J. Mullen, K. Huynh-Ba, V. A. Gray, N. Gangrade, DPC Analytical Symposium, Wilmington, DE, October 14, 1998.
  8. “Dissolution Method Development for DMP 961 Tablets”, J. Xu, K. Huynh-Ba, D. Bindra, S. Badawy, DPC Analytical Symposium, Wilmington, DE, October 14, 1998.
  9. “Evaluation of AR&D dissolution baths using mechanical parameters and the NCDA #2 calibrator tablets”, J. Scott, T. McCummings, K. Huynh-Ba, V. A Gray, DuPont Summer Intern Poster Session, Wilmington, DE, August 16, 1998.
  10. “Comparison of Stability Study Designs”, K. Huynh-Ba and M. A. Gorko, AAPS National Meeting, Seatle, WA, October 29, 1996.
  11. “Statistical Evaluation for Naltrexone Hydrochloride (ReVia) Tablets”, K. Huynh-Ba, K. R. Lung and M. A. Gorko, DMPC Analytical Symposium, Wilmington, DE, October 20, 1995.
  12. “Comparison of Stability Study Matrixing Designs”, K. Huynh-Ba and M. A. Gorko, DMPC Analytical Symposium, Wilmington, DE, October 20, 1995.
  13. “HPLC Method Development and Validation of DMP 728”, K. Huynh-Ba, S. L. Kintner and B. J. Mueller, DMPC, Science Commitment Conference, Newark, DE, August 26, 1993.
  14. “DMP 728 Clinical IV formulation Development”, K. Huynh-Ba, S. L. Kintner, B. J. Mueller, T. J. Lee, T. Y. Lee and C. A. Abboud, DMPC, Science Commitment Conference, Newark, DE, August 26, 1993.
  15. “Compatability of DMP 728 IV Formulation with PVC/Non-PVC Infusion Bags and Tubing Sets”, K. Huynh-Ba, S. L. Kintner, B. J. Mueller, C. A. Abboud, M. A. Ramos and T. Y. Lee, DMPC, Science Commitment Conference, Newark, DE, August 26, 1993.


Highlights

  • Coming soon.

"Introduction of Pharmaceutical Analysis"

Expected in September 2016,
John Wiley & Sons Publisher.

by K. Huynh-Ba (ed.)



Pharmaceutical Stability Testing to Support Global Markets

February 2010,
Springer Publisher & AAPS.

by K. Huynh-Ba (ed.)



"Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices"

November 2008,
Springer Publisher.

by K. Huynh-Ba (ed.)


Contact Info



Pharmalytik

Newark, DE USA


info@pharmalytik.com


(302) 731-9959