Papadopoulou Lefkothea
Mansoor A Khan, RPh, PhD
  • Division of Product Quality Research, OTR/OPQ
    Food and Drug Administration
    New Hampshire Avenue, Silver Spring, USA
    Phone: 301-796-0016




Ph.D. in Pharmaceutics (focus on industrial pharmacy and biopharmaceutics)

St. John's University, College of Pharmacy and Allied Health Professions, New York.


M.S. in Pharmaceutics (focus on physical pharmacy and drug delivery systems)

Idaho State University, Idaho.


M.S. in Pharmaceutical Technology

Andhra University, India



Dr. Mansoor A. Khan is the Director of Product Quality Research and a Senior Biomedical Research Scientist (SBRS) at CDER in FDA where he leads research teams on biotech products, chemistry and stability, drug delivery systems and bioavailability/bioequivalence. Prior to joining FDA in 2004, he was a Professor of Pharmaceutics and Director of Graduate Program in the School of Pharmacy at Texas Tech University Health Science. He is a registered pharmacist, and earned his Ph.D. degree in Industrial Pharmacy from the St. John's University School of Pharmacy in 1992. He has published over 275 peer-reviewed manuscripts, four texts including "Pharmaceutical and Clinical Calculations", 25 book chapters, 200 poster presentations, and more than 175 invited presentations world-wide. He has held several leadership positions at the AAPS including elected chair of pharmaceutics and drug delivery (PDD) and the founding chair of formulations design and development (FDD).  He serves on the editorial board of Pharmaceutical Technology, International Journal of Pharmaceutics, AAPS Pharmsci Tech, and Drug Delivery and Translational Research.  He has received the AAPS Research Achievement Award in Formulations Design and Development in 2012, and is an AAPS Fellow.

Research Interest

  • Formulations design and development
  • Bioavailability/Bioequivalence
  • Novel Drug Delivery Systems


Professional Activities:

Teaching Experience:

2004- Present

Food and Drug Administration, Maryland, USA

2005- Present

Director, Division of Product Quality Research, Center for Drug Evaluation and Research SBRS Scientist

2000- 2004

Professor of Pharmaceutics and Director of Graduate Program, Texas Tech University Health Sciences Center, School of Pharmacy

1998- 2000

Associate Professor of Pharmaceutics and Director of Graduate Program, Texas Tech University Health Sciences Center, School of Pharmacy

1996- 1998

Associate Professor of Pharmaceutics, University of Louisiana at Monroe

1992- 1996

Assistant Professor of Pharmaceutics, University of Louisiana at Monroe

Professional Organizations:


AAPS awards committee member


NIH Study Section, Eunice Kennedy Shriver NICHD, ZHD1 DSR-K (PT), 2009, 2010, and 2011, BTSS section


DARPA Peer review Committee


Planning Committee Member and Moderator, Charles Jarowski Sympoium, ST. Johns University, NY.
Fellows Committee Chair, FDD, AAPS.
Fellows Committee Member, AAPS National Committee.
Panel Member, Quality by Design Workshop, European Compliance Agency, Austria.
Member planning committee for the AAPS/FDA workshop on simulations, Bethesda, MD


Member, planning committee for international workshop on excipients by United States Pharmacopoea


Moderator and Co-Chair, AAPS Workshop on Quality by Design in Analytical Sciences.
Moderator and C0-Chair, FIP International workshop in Basel, Switzerland.
Moderator and C0-Chair, International Workshop on Quality by Design, Antalya, Turkey.
Moderator and Co-Chair: AAPS Workshop on Dissolution, Arlington, VA.
Moderator and Co-Chair, Charles Jarowski Symposium, St. Johns University, NY.
Moderator and C-Chair, International Pharmaceutical Technology Symposium (IPTS), Antalya, Turkey.
Moderator, AAPS Round Table on Quality by Design, AAPS National Meeting.
Founding Chair, AAPS Formulations Design and Delivery Section


Member Planning Committee, AAPS PDD Open Forum on Quality by Design.
Elected Chair of the Pharmaceutics and Drug Delivery Section of the AAPS.
Planning Committee Member, Controlled Release Society Workshop, CA.
Planning Committee Member, AAPS Workshop on Stability


International Federation of Pharmacy (FIP), Organizing committee member

Honors and Awards:


FDA/CDER: Regulatory Science Excellence Award. Chemometric methods for tacrolimus crystallinity


FDA Group Recognition Award. Unapproved Cough, Cold, and Allergy Enforcement Group.
FDA Group Recognition Award. CDER QBD and PAT Workshop Planning and Advisory Committee


CDER Team Excellence Award for development of Post Approval Chewable Tablet Policies.
Team Excellence Award for size of beads in products labelled for sprinkle.
Team Excellence Award: Phthalates as excipients in CDER regulated products.
FDA Group Recognition Award for the creation and launching of FDA’s Strategic Plan for Regulatory Science.


CDER Team Excellence Award for development of a new dissolution method to demonstrate bioequivalence of Vancomycin hydrochloride to allow submissions of ANDA


CDER Center Director’s Special Citation for exemplary performance in providing innovative and emerging science to CDER.
College of Pharmacy Excellence Award, Texas A&M Health Science Center


CDER Team Excellence Award for outstanding efforts in identifying the impact of tablet splitting on product stability.
Outstanding ALUMNUS award for career achievements at St. John’s University, New York convocation.


CDER Scientific Achievement Award, “Excellence in Analytical Science,” Presented to Research Team for Development of Chemometric, Spectroscopic and Imaging Tools to Assess Pharmaceutical Quality.
Sigma Xi Outstanding Poster Winner (Coauthor) in FDA “Imaging-Based Algorithms for Determining the Uniformity of Drug Products and Blends.”


Team Excellence Award for outstanding efforts in identifying a potentially fatal alcohol related adverse reaction with Palladone in CDER, FDA.
Team Excellence Award for outstanding performance in CDER Visiting Professor Lecture Series, CDER/FDA



  1. Awotwe-Otoo D, Agarabi C, Read EK, Lute S, Brorson KA, Khan MA, Shah RB. Impact of Controlled Ice Nucleation on process performance and quality attributes of a lyophilize monoclonal antibody, Int J Pharm. 2013 Jun 25;450(1-2):70-8.
  2. Xu X, Gupta A, Faustino P, Sathe PM, Sayeed VA, Khan MA*., Development and Validation of a HPLC Method for Dissolution and Stability Assay of Liquid-Filled Cyclosporine Capsule Drug Products. AAPS PharmSciTech. 2013 Sep;14(3):959-67.
  3. Siddiqui, A., Shah, RB, and Khan, MA*. Oseltamivir Phosphate-Amberlite IRP 64 Ionic Complex for Taste-Masking: Preparation and Chemometric Evaluation. J. Pharm. Sci., 2013 Jun; 102(6):1800-12.
  4. Rahman, Z., Siddiqui A., and Khan, M*. Orally disintegrating tablet of novel salt of antiepileptic drug: Formulation strategy and evaluation. Eur. J. Pharm. Biopharm., 2013 Nov;85(3 Pt B):1300-9.
  5. Krishnaiah YS, Yang Y, Bykadi S, Sayeed VA, Khan MA. Comparative evaluation of in vitro efficacy of colesevelam hydrochloride tablets. Drug Dev Ind Pharm. 2013 Jun. [Epub ahead of print].
  6. Anne Zajicek, Michael J. Fossler, Jeffrey S. Barrett, Jeffrey H. Worthington, Robert Ternik, Georgia Charkoftaki , Susan Lum, JörgBreitkreutz, Mike Baltezor, Panos Macheras , Mansoor Khan, Shreeram Agharkar , David Douglas MacLarenA Report from the AAPS Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Dosage Forms, aaps journal, 2013 Oct;15(4):1072-81.
  7. Firat, Aysegul Ozgen, Imran Vural, Olgun Guven, Ergun Karaagaoglu, Mansoor A. Khan, Yilmaz Capan, Development and Evaluation of Paclitaxel Nanoparticles Using a Quality-by-Design (QbD) Approach, J. Pharm. Sci., 2013 Oct;102(10):3748-61.
  8. Zidan Ahmed, Crystal B. Spinks, Muhammad J. Habib and Mansoor A. Khan * .Formulation and transport properties of tenofovir loaded liposomes through Caco-2 cell model, J Liposome Res. 2013 Dec;23(4):318-26.
  9. Chava Kimchi-Sarfaty, Tal Schiller, Nobuko Katagiri, Mansoor Khan, Chen Yanover and Zuben E. Sauna, Developing and Regulating Engineered Therapeutic Proteins, Trends Pharmacol Sci. 2013 Oct;34(10):534-48.
  10. Ziyaur Rahman and Mansoor Khan*, Hunter screening design to understand the product variability of solid dispersion formulation of a peptide antibiotic Int J Pharm. 2013 Nov;456(2):572-82. Epub 2013 Aug.
  11. Rahman, Z., Siddiqui, A., and Khan, MA*., Assessing the impact of nimodipine devitrification in the ternary cosolvent system through quality by design approach, Int. J. Pharm., 2013 Oct;455(1-2). Epub 2013 Jul.
  12. Akhtar Siddiqui, Ziyaur Rahman, Vilayat Sayeed, Mansoor A. Khan*, Chemometric Evaluation of Near Infrared, Fourier Transform Infrared, and Raman Spectroscopic Models for the Prediction of Nimodipine Polymorphs. J Pharm Sci., 2013 Nov; 102(11):4024-35. Epub 2013 Aug.
  13. Xiaoming Xu, Ziyaur Rahman, and Mansoor Khan*. Focused Beam Reflectance Measurement to Monitor Nimodipine Precipitation Process. Int J Pharm. 2013 Nov; 456(2) :353-6.Epub 2013 Sep.
  14. Ziyaur Rahman and Mansoor Khan*. Characterization of A Non Ribosomal Peptide Antibiotic Solid Dispersion Formulation By Process Analytical Technologies (Pat) Sensors. J Pharm Sci. 2013 Dec;102(12) :4337-46. Epub 2013 Oct.
  15. Gupta, A. and Khan, M. Challenges of Pediatric Product Development. A FDA Science Perspective, Int J Pharm. 2013 Nov; 457(1):346-8.
  16. Anwesha Chaudhury, Huiquan Wu, Mansoor Khan, Rohit Ramachandran. A mechanistic population balance model for granulation processes: Effect of process and formulation parameters. Chemical Engineering Science. 107(2014) 76-92.
  17. H.Wu, M. White, R. Berendt, R, Foringer, M. Khan. An Integrated PAT Approach for Nucleation Induction Time Measurement and Nucleation Mechanism Assessment for a Dynamic Multi-Component Pharmaceutical Antisolvent Crystallization System. Ind. Eng. Chem. Res., 2014 Jan, 53 (4):1688–1701.Epub 2014 Jan.
  18. Johnson, Gibbes, Madhavarao, Chikkathur; Agarabi, Cyrus, Wong, Lily;.de; braulke, Khan, Mansoor, Anderson, Howard . Evaluation of Butyrate Induced Production of a Mannose-6-Phosphorylated Therapeutic Enzyme Using Parallel Bioreactors". Biotechnol Appl Biochem.184-192, 2014.
  19. Shivani V. Gandhi, William Rodriguez, Mansoor Khan, and James E. Polli,. Considerations for a pediatric Biopharmaceutics classification system (BCS): Application to five drugs. AAPS PharmSciTech. 2014 Feb. [Epub ahead of print].
  20. Geoffrey K. Wu, Abhay Gupta, Mansoor A. Khan, Patrick J. Faustino. Development and Application of a Validated HPLC Method for the Determination of Clindamycin Palmitate Hydrochloride in Marketed Drug Products: An Optimization of the Current USP Methodology for Assay. JASMI.2013Dec, 3(4): 202-11.
  21. Saeed R Khan, Ravikanth Kona, Patrick J. Faustino, Abhay Gupta, Jeb S. Taylor, Mansoor Khan. Journal of Pharmaceutical Sciences. FDA and DoD Shelf Life Extension Program of Pharmaceutical Products: Progress and Promises. J Pharm Sci. 2014 May; 103(5):1331-6. Epub 2014 Mar.
  22. Gupta A, Chidambaram N, and Khan MA, An index for evaluating difficulty of chewing the chewable tablets. Drug Dev Ind Pharm. 2013 Nov . [Epub ahead of print].
  23. Z. Rahman, X. Xu, U. Katragadda, Y. Krishnaiah, L. Yu, and M. Khan, Quality by Design Approach for Understanding the Critical Quality Attributes of Cyclosporine Ophthalmic Microemulsion. Mol Pharm. 2014 Jan. [Epub ahead of print].
  24. Rakhi B. Shah, Yongsheng Yang, Mansoor A. Khan, Andre Raw, Lawrence X. Yu, and Patrick J. Faustino. Thermodynamic stability assessment of a colloidal iron drug product: Iron sucrose. Int J Pharm. 2014 Apr ;464(1-2):46-52. Epub 2014 Jan.
  25. Stuart Cantor, Abhay Gupta, and Mansoor Khan*, Analytical methods for evaluation of melamine contamination, J Pharm Sci. 2014 Feb;103(2):539-44. Epub 2013 Dec.
  26. Lawrence X. Yu, Gregory Amidon, Mansoor A. Khan, Stephen W. Hoag, and James Polli, G. K. Raju, and Janet Woodcock, Understanding Quality by Design, AAPS Journal, 2014, accepted for publication.
  27. Akhtar Siddiqui, Ziyaur Rahman, Srikant Bykadi, and Mansoor Khan*, Chemometric methods for the quantification of crystalline tacrolimus in solid dispersion by powder X-ray diffractometry, J Pharm Sci. 2014 Mar. [Epub ahead of print].
  28. Yelella Krishnaiah, Usha Kattragadda, and Mansoor Khan*, Stereomicroscopic imaging technique for the quantification of cold flow in drug-in-adhesive type of transdermal drug delivery systems, J. Pharm. Sci., 2014, 103: 1433-1442.
  29. David Awotwe, Cyrus Agarabi, and Mansoor Khan*. An Integrated Process Analytical Technology (PAT) approach to monitoring the effect of super-cooling on lyophylization product and process parameters of model monoclonal antibody formulations, J. Pharm. Sci., Accepted, 2014.
  30. Janet Woodcock, and Mansoor Khan*, FDA Analysis of Atorvastatin Products Refutes Report of Methylester Impurities. Ther. Innov. And Reg. Sci., Accepted 2014.
  31. Akhtar Siddiqui, Ziyaur Rahman, and Mansoor Khan*, Application of Chemometric Methods to Differential Scanning Calorimeter (DSC) to Estimate Nimodipine Polymorphs from Cosolvent System. Drug Develop. Ind. Pharm., 2014 May 26: 1-5.
  32. Ziyaur Rahman, Akhtar Siddiqui, Srikant Bykadi, NIR and FTIR Chemometric Methods for Quantification of Crystalline Tacrolimus from Sustained Release Amorphous Solid Dispersion, and Mansoor Khan*, J. Pharm. Sci., Accepted 2014.
  33. Wu, Huiquan; Dong, Zedong; Li, Haitao; Khan, Mansoor, An Integrated Process Analytical Technology (PAT) Approach for Pharmaceutical Crystallization Process Understanding to Ensure Product Quality and Safety: FDA Scientist’s Perspective. J. Organic Process Research and Development., Accepted 2014.
  34. Stuart Cantor, Abhay Gupta, and Mansoor Khan*, Development and Optimization of Taste-Masked Orally Disintegrating Tablets (ODTs) of Clindamycin Hydrochloride, Drug Develop. and Ind. Pharm., Accepted, 2014.
  35. Akhtar Siddiqui, Ziyaur Rahman, and Mansoor Khan*, Root Cause Evaluation of Particulates in the Lyophilized Indomethacin Sodium Trihydrate Plug for Parenteral Administration, Int. J. Pharm., Accepted, 2014.
  36. Wu, Huiquan, White, Maury, and Khan, Mansoor. An Integrated Process Analytical Technology (PAT) Approach for Process Dynamics-related Measurement Error and Process Design Space Development for a Pharmaceutical Powder Blending Bed. . J. Organic Process Research and Development., Accepted 2014.
  37. Yellela S.R. Krishnaiah, Xiaoming Xu, Ziyaur Rahman, Yang Yang, Usha Katragadda, Robert Lionberger, John R. Peters, Kathleen Uhl, Mansoor A. Khan1,* Development of Performance Matrix for Generic Product Equivalence of Acyclovir Topical Creams, Int. J. Pharm., Accepted, 2014.
  38. Moolchandani, V., Gupta, A. Augsburger, A., Khan, M., and Hoag, S. Characterization and Selection of Suitable Grades of Lactose as Functional Fillers for Capsule Filling: Part 1., Drug. Dev. Ind. Pharm., 2014, Accepted for publication.
  39. Ziyuar Rahman, Akhtar Siddiqui, Srikant Bykadi, and Mansoor Khan*, Determination of tacrolimus crystalline fraction in the commercial immediate release amorphous solid dispersion products by a standardized X-ray powder diffraction method with chemometrics. Accepted in Int. J. Pharm., 2014.
  40. Krishanaiah, Y., Yang, Y., Hunt, R., and Khan, M., Cold flow of estradiol transdermal systems: Influence of drug loss on the in vitro flux and drug transfer across human epidermis. Accepted for publication in Int. J. Pharm. 2014.
  41. Mohammad, A., Carlin A., Faustino, P, Khan, M., and Yang Y., Long-term stability study of Prussian blue -A quality assessment of water content and thallium binding. Accepted for publication in Int. J. Pharm. 2014.
  42. Adil, M., Yang, Y., Khan, M. and Faustino. Long-term stability study of Prussian Blue-A quality assessment of water content and cyanide release. Clinical Toxicology. 2014. Accepted for publication.