• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Division of Product Quality Research Recent Publications

Federal Research Center Life Sciences
Life Sciences Building 64, 1st Floor
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-0012 Fax: (301) 796-9818

Mansoor Khan, Ph.D., Director

Recent Publications

Journal Articles

Book Chapters 

Journal Articles


Faustino, PJ, Yang, Y, Progar, JJ, Brownell, CR, Sadrieh, N, May, JC, Leutzinger, E, Place, DA, Duffy, EP, Houn, F, Loewke, SA, Mecozzi, VJ, Ellison, CD, Khan, MA, Hussain, AS and Lyon, RC: Quantitative Determination of Cesium Binding to Ferric Hexacyanoferrate: Prussian Blue.  J. Pharm. Biomed. Anal.  doi: 10.1016/j.jpba. 2007.11.049 (accepted 11/07)

Shah RB, Prasanna HR, Rothman B, and Khan MA. ‘Stability of Ranitidine Syrup in Repackaged Unit-dose Container’ American Journal of Health-System Pharmacy, in press, 2008 (accepted 02/07).

Shah RB, Tawakkul MA, and Khan MA. ‘Comparative evaluation of flow of pharmaceutical powders and granules’, AAPS PharmSciTech, In press (accepted on 01/10/08).

Shah RB, Yang Y, Khan MA, and Faustino PJ. ‘Molecular weight determination for colloidal iron by Taguchi optimized validated gel permeation chromatography’, International Journal of Pharmaceutics. doi:10.1016/j.ijpharm.2007.11.025   (accepted 11/07).

Volpe, DA: Variability in Caco-2 and MDCK cell-based intestinal permeability assays.  J. Pharm. Sci., 97:712-725, 2008.

Volpe DA, Gupta A, Ciavarella AB, Faustino PJ, Sayeed VA, and Khan MA. Comparison of the Stability of Split and Intact Gabapentin Tablets. Int. J. Pharm. 2008. doi:10.1016/j.ijpharm. 2007.08.041 (accepted 8/2007).

Wu, H, Heilweil, EJ, Hussain, AS, Khan, MA: Process Analytical Technology: Quantification Approaches in Terahertz Spectroscopy for Pharmaceutical Applications.  J. Pharm. Sci., 97(2):958-971, 2008.

Xie, L.,Wu, H., Shen, M., Augsburger, L., Lyon, R.C., Khan, M.A., Hussain, A.S.,and Hoag, S.W. Quality-by-Design (QbD): Effects of Testing Parameters and Formulation Variables on the Segregation Tendency of Pharmaceutical Powder Measured by the ASTM D 6940-04 Segregation Tester.J. Pharm. Sci., 2008. In Press.

Yang, Y,Faustino, PJ, Progar, JJ, Brownell, CR, Sadrieh, N, May, JC, Leutzinger, E, Place, DA, Duffy, EP, Yu, LX, Khan, MA, and Lyon, RC: Quantitative Determination of Thallium Binding to Ferric Hexacyanoferrate: Prussian blue, Int. J. Pharm. doi:10.1016/j.ijpharm.2007.11.031  (accepted Nov. 2007).    

Back to Top


Asafu-Adjaye, EB,  Faustino, PJ, Tawakkul, MA, Yu, LX, Kwon, H, Volpe, DA: Validation and application of a stability-indicating method for the in vitro determination of gastric and intestinal stability of venlafaxine: Identification of the degradation impurity.  J. Pharm. Biomed  Anal. 43(5): 1854-9, 2007.

Chen, ML, Straughn, AB, Sadrieh, N, Meyer, M, Faustino, P, Ciavarella, A, Meibohm, B, Yates, CR, Hussain, AS: A Modern View of Excipient: Effects on Bioequivalence: Case Study of Sorbitol, Pharm. Res. 24(1): 73-80, 2007

Ciavarella, AB, Gupta, A, Sayeed, VS, Khan, MA, Faustino, PJ.  Development and application of a validated HPLC method for the determination of gabapentin and its major degradation impurity in drug products. J. Pharm. Biomed  Anal. 43(5): 1647-53, 2007.

Gupta A, Ciavarella AB, Sayeed VA, Khan MA, and Faustino PJ. Development and application of a validated HPLC method for the analysis of dissolution samples of gabapentin drug products. J. Pharm. Biomed. Anal. 46 (1):181-186, 2007

Hamad ML, Ellison CD, Khan MA, Lyon RC; Drug Product Characterization by Macropixel Analysis of Chemical Images, .J. Pharm. Sci., 96, 3390-3401, 2007.

Motlekar, NA, Khan, MA, Nguyen, NT, Youan, BC: Enhanced dissolution profile of genistein following microencapsulation into poly(ethylene glycol) matrix” J Appl Polymer Sci 2007, In Press.

Nutan, M, Vaithiyalingam, SR, Khan, MA: Controlled release multiparticulate beads coated with cellulose acetate; Identification of critical formulation and process variables, Pharm. Dev. Technol., 2007, In Press.

Shah RB and Khan MA. ‘The evolution of FDA’s role in regulating product quality’, Pharmaceutical Technology, July: 52-58, 2007.

Shah, RB, Tawakkul, MA, Khan, MA:  Process analytical technology: Chemometric analysis of Raman and near Infra-red spectroscopic data for predicting physical properties of extended release matrix tablets J. Pharm. Sci. 96(5): 1356-65, 2007

Shah RB, Zidan AS, Funck T, Tawakkul MA, Nguyenpho A, and Khan MA. ‘Quality by Design: Characterization of self nano-emulsified drug delivery systems (SNEDDs) using ultrasonic resonator technology’ International Journal of Pharmaceutics, 341(1-2):189-194, 2007.

Snorek, SS, Bauer, JF, Chidambaram, N, Doub, WH, Duffy, EP, Etzler, FM, Prasanna, H, Kelly, RN, Lane, JJ, Mueller, RL, Pujara, CP, Reif, VD, Scarlett, B, Stowell, JG, Toma, PT: PQRI Recommendations on Particle-Size Analysis of Drug Substances Used in Oral Dosage Forms, J. Pharm. Sci. 96(6): 1451-67, 2007

Volpe, DA, Faustino, PJ, Ciavarella, AB, Asafu-Adjaye, EB, Ellison CD, Yu, LX, Hussain, AS: Classification of Drug Permeability with a Caco-2 Cell Monolayer Assay. Clin. Res. Reg. Affairs, 2007, In Press.

Wu, H , Hussain, AS, Khan, MA: Process Control Perspective for Process Analytical Technology: Integration of Chemical Engineering Practice into Semiconductor and Pharmaceutical Industries. Chem. Eng. Comm., 194: 760-79, 2007

Wu, H, Heilweil, EJ, Hussain, AS, Khan, MA:  Process Analytical Technology (PAT): Effects of Instrumental and Compositional Variables on Terahertz Spectral Data Quality to Characterize Pharmaceutical Materials and Tablets. Int. J. Pharm., 343(1-2):148-158, 2007

Yang, Y, Faustino, PJ, Volpe, DA, Ellison, CD, Lyon, RC, Yu, LX: Biopharmaceutics Classification of Selected ß-Blockers: Solubility and Permeability Class Membership. Mol. Pharm. 4, 608-614, 2007.

Yang, Y, Brownell, CR, Sadrieh, N, May, JC, Del Grosso, AV, Lyon, RC, Faustino, PJ: Validation of an in vitro Method for the Determination of Cyanide Release from Prussian Blue. J. Pharm. Biomed. Anal, 43(4): 1358-63, 2007

Yang, Y, Brownell, CR, Sadrieh, N, May, JC, Del Grosso, AV, Place, DA, Leutzinger, EE, Duffy, EP, He, R, Houn, F, Lyon, RC, Faustino, PJ: Quantitative Determination of Cyanide Released from Prussian Blue: An Assessment of Safety. Clin. Toxicol. 45 (7): 776 – 781.

Zidan, AS, Sammour, OA, Hammad, MA, Megrab, NA, Habib, MJ, Khan, MA: Process Analytical Technology: Nondestructive Assessment of Anastrozole Entrapment within PLGA Microparticles by Near Infrared Spectroscopy and Chemical Imaging, J Microencapsulation, 2007, In Press.

Zidan, AS, Sammour, OA, Hammad, MA, Megrab, NA, Habib, MJ, Khan, MA: Understanding the Product Variability of a Self-Nanoemulsified Drug Delivery System of Cyclosporine A, J. Pharm. Sci., 2007, In Press.

Zidan, AS, Sammour, OA, Hammad, MA, Megrab, NA, Habib, MJ, Khan, MA: Quality by Design: Characterization of self nano-emulsified drug delivery systems (SNEDDs) using ultrasonic resonator technology. Int. J. Pharm. 332(1-2): 55-63, 2007

Back to Top


Faustino, P, Chan, CC, Carrano, J, Gosnell, M, Gu, ZQ, Maule, A, Sigvardson, K: Report on the PQRI impurity characterization and quantification best practices survey Pharm. Res., 23 (2): 440-446, 2006

Lyon, RC, Taylor, JS, Porter, DA, Prasanna, HR, Hussain, AS: Stability profiles of drug products extended beyond labeled expiration dates J Pharm Sci, 95: 1549-60, 2006.

Nazzal, S, Khan, MA: Controlled Release of a Self-Emulsifying (SEDDS) Formulation from a Tablet Dosage Form: Stability Assessment and Optimization of Some Processing Parameters . Int. J. Pharm, 315: 110-121, 2006.

Prasanna, HR, Hanig, JP, Flora, KP: Comparative study of the chromatographic and Bio-assay procedure for the determination of vasopressin potency, US Pharmacopeial Forum, Stimuli to the Revision Process, 32(6): 2006.

Shah, RB, Tawakkul, MA, Prasanna, HT, Faustino, PJ, Nguyenpho, A, Khan, MA: Development of a validated stability indicating HPLC method for Ranitidine hydrochloride syrup, Clin. Res. Reg. Affairs 23:35-51, 2006.

Sharpless KE, Anderson DL, Betz JM, Butler TA, Capar SG, Cheng J, Fraser CA, Gardner G, Gay ML, Howell DW, Ihara T, Khan MA, Lam JW, Long SE, McCooeye M, Mackey EA, Mindak WR, Mitvalsky S, Murphy KE, NguyenPho A, Phinney KW, Porter BJ, Roman M, Sander LC, Satterfield MB, Scriver C, Sturgeon R, Thomas JB, Vocke RD Jr, Wise SA, Wood LJ, Yang L, Yen JH, Ziobro GC: Preparation and Characterization of a Suite of Ephedra-Containing Standard Reference Materials. J AOAC Int. 89(6):1483-95, 2006.

Zaghloul, AA, Mustafa, F, Siddiqui, A, Khan, MA: Biodegradable microparticulates of beta- estradiol: Preparation and in vitro characterization, Drug Dev. Ind. Pharm. 31(8), 803-811, 2006.

Zaghloul, AA, Mustafa, F, Siddiqui, A, Khan, MA: Response surface methodology to obtain beta-estradiol biodegradable microspheres for long term therapy of osteoporosis, Pharm Dev Technol. 11(3): 377-387, 2006.

Zidan, AS, Sammour, OA, Hammad, MA, Megrab, NA, Hussain, MD, Khan, MA, Habib, MJ: Formulation of Microparticles as Anastrozole Biodegradable Anticancer Drug Carriers, AAPS PharmSciTech. 7(3): Article 61, 2006.

Back to Top


Gupta, A Peck, GE Miller, RW Morris, KR: Real-Time Near-Infrared Monitoring of Content Uniformity, Moisture Content, Compact Density, Tensile Strength and Young’s Modulus of Roller Compacted Powder Blends. J. Pharm. Sci., 94 (7): 1589-1597, 2005.

Gupta, A Peck, GE Miller, RW Morris, KR: Influence of the Ambient Moisture on the Compaction Behavior of Microcrystalline Powder Undergoing Uni-Axial Compression and Roller-Compaction: A Comparative Study Using Near-Infrared Spectroscopy. J. Pharm. Sci. 94 (10): 2301-2313, 2005.

Gupta, A Peck, GE Miller, RW Morris, KR: Effect of the Variation in the Ambient Moisture on the Compaction Behavior of Powder Undergoing Roller-Compaction and on the Characteristics of Tablets Produced from the Post-Milled Granules. J. Pharm. Sci. 94 (10): 2314-2326, 2005.

Jasper, JP, Lyon, RC, Weaner, LE: Stable Isotopes Provide a New PAT Tool. Pharm. Manuf. May: 28-33, 2005.

Miller, RW Gupta, A Morris, KR: ‘Roller Compaction Scale-Up’ Chapter 9 in Drugs and the Pharmaceutical Sciences, 157 (Pharmaceutical Process Scale-Up), M. Levin ed, Second Edition, Marcel Dekker Inc, New York, NY, 2005.

Nutan, M Soliman, M, Taha, E, Khan MA: Optimization and characterization of controlled release multi-particulate beads coated with starch acetate, Int. J. Pharm., 294 (1-2): 89-101, 2005.

Palamakula, A, Soliman, M, Khan, MA: Regional Permeability of Coenzyme Q10 in Isolated Rat Gastrointestinal Tract, Pharmazie 60(3): 212-14, 2005.

Shah, RB, Khan, MA: Oral Delivery of Salmon Calcitonin with Ovomucoids, American Pharmaceutical Review, 8(1): 45-47, 2005.

Soliman, M, Khan MA: Preparation and in vitro characterization of semi-solid dispersion of flurbiprofen with Gelucire 44/14 and Labrasol,  Pharmazie 60(4):288-293, 2005,.

Taha, E, Samy, A, Kassem, A, Khan MA: Response surface methodology for the development of self-nanoemulsified drug delivery system (SNEDDS) of all-trans retinolol,  Pharm. Dev. Technol., 10: 363-370, 2005.

Tatavarti, AS, Fahmy, R, Wu, H, Hussain, AS, Marnane, W, Bensley, D, Hollenbeck, G, Hoag, SW: Assessment of NIR Spectroscopy for Nondestructive Analysis of Physical and Chemical Attributes of Sulfamethazine Bolus Dosage Forms. AAPS PharmSciTech 1(1), article 15, 2005.

Vaithiyalingam, S, Ahmed, S, Khan MA: Current Status of Controlled Drug Delivery, Drug Deliveries Companies Report (UK), Spring Summer 2005, 30-33.

Westenberger, BJ, Ellison, CD, Fussner, AS, Jenney, S, Kolinski, RE, Lipe, TG, Lyon, RC, Moore, TW, Revelle, LK, Smith, AP, Spencer, JA, Story, KD, Toler, DY, Wokovich, AM, Buhse, LF: Quality Assessment of Internet Pharmaceutical Products using Traditional and Non-Traditional Techniques. Int. J. Pharm. 306, 56-70, 2005.

Yang, Y, Faustino, PJ, Pine, PS, Davis, H, Grinberg, N, Phillips, J, Lyon, RC, Yu, LX, Ciavarella, AB, Del Grosso, AV, Hanig, JP: Determination of plasma and brain levels of isotretinoin in mice following single oral dose by high-performance liquid chromatography” J. Pharm. Biomed. Anal. 37, 157-163 2005.

Back to Top


Gupta, A, Peck, GE Miller, RW Morris, KR: Non-Destructive Measurements of the Strength and the Particle-Size Distribution upon Milling of Compacts by Near-Infrared Spectroscopy. J. Pharm. Sci., 93 (4): 1047-1053, 2004.

Hussain, A, Arnold, J, Khan, M, Ahsan, F: Absorption Enhancers in Pulmonary Peptide Delivery. J. Control. Rel. 94(1): 15-24, 2004.

Miller, RW Gupta, A, Roller Compaction: A PAT Application Using Near-Infrared In-Process Mapping, Monitoring and Characterization. Am. Pharm. Res., 7 (1): 69-76, 2004.

Mustafa, F, Yang, T, Khan, M, Ahsan, F: Chain Length Dependent Effects of Alkylmaltosides on Nasal Absorption of Enoxaparin. J. Pharm. Sci., 93(3): 675-83, 2004.                                                  

Palamakula, A, Nutan, M, Khan, MA: Response Surface Methodology for Optimization and Characterization of Limonene Based Coenzyme Q10 Self-Nanoemulsified Capsule Dosage Form, AAPS PhamSciTech, April, Vol 5, 2004.

Palamakula, A, Soliman, M, Reddy, IK, Khan, MA: Preparation and In Vitro Characterization of Self-Nanoemulsified Capsules with Limonenes, Pharm. Technol., Oct: 74-88, 2004.

Palamakula, A, Khan MA: Evaluation of Cytotoxicity of Oils Used in Coenzyme Q10 Self-Emulsifying Drug Delivery Systems (SEDDS),  Int. J. Pharm., 273 (1-2): 63-73, 2004.

Polli JE, Yu LX, Cook JA, Amidon GL, Borchardt RT, Burnside BA, Burton PS, Chen ML, Conner DP, Faustino PJ, Hawi AA, Hussain AS, Joshi HN, Kwei G, Lee VH, Lesko LJ, Lipper RA, Loper AE, Nerurkar SG, Polli JW, Sanvordeker DR, Taneja R, Uppoor RS, Vattikonda CS, Wilding I, Zhang G: Summary workshop report: Biopharmaceutics classification system--implementation challenges and extension opportunities. J Pharm Sci. 93(6): 1375-81, 2004.

Scallet, AC, Schmued, LC, Slikker, Jr., W, Grunberg, N, Faustino, PJ, Davis, H, Lester, D, Pine, PS, Sistare, F, Hanig, JP:Developmental neurotoxicity of ketamine morphometric confirmation, exposure parameters, and multiple fluorescent labeling of apoptotic neurons. Toxicol. Sci. 81: 364-370, 2004.

Shah, RB, Palamakula,A, Khan, MA: ‘Cytotoxicity evaluation of enzyme inhibitors and absorption enhancers in Caco-2 cells for oral delivery of salmon calcitonin’ J. Pharm. Sci., 93: 1070–1082, 2004.

Shah, RB, Khan, MA: Protection of salmon calcitonin breakdown with serine protease by various ovomucoid species for oral drug delivery, J.Pharm. Sci., 93: 392-406, 2004.

Shah, RB, Khan, MA: Regional permeability of salmon calcitonin in isolated rat gastrointestinal tracts: Transport mechanism using Caco-2 cell monolayer, AAPS PharmSci., 6(4): Article 34, 2004.

Shah, RB, Nutan, MT, Reddy, IK, Khan, MA: An enteric dual-controlled gastrointestinal therapeutic system of salmon calcitonin. II. Screening of process and formulation variables, Clin. Res. Reg. Affairs 21(3-4): 231-238, 2004.

Shah, RB, Nutan, MT, Khan, MA: An enteric dual-controlled gastrointestinal therapeutic system of salmon calcitonin. I. Preparation, characterization and preclinical bioavailability in rats, Clin. Res. Reg. Affairs 21 (1-2): 81–96, 2004.

Sharpless, KE, Sander, LC, Wise, SA, NguyenPho, A, Lyon, RC, Ziobro, GC, Betz, JM: Development of Standard Reference Materials for Dietary Supplements. HerbalGram, 63: 44-47, 2004.

Taha, E, Zaghloul, ZA, Al-Saidan, S, Khan MA: Bioavailability Assessment of Salbutamol Sulfate Suppositories in Human Volunteers, Int. J. Pharm. 279(1-2): 3-7, 2004.

Taha, EI, Saleh Al-Saidan, S, Samy, AM, Khan, MA: Preparation and in-vitro characterization of self-nanoemulsified drug d elivery system (SNEDDS) of all trans-retinol acetate, Int. J. Pharm. 285(1-2): 109-19, 2004.

Volpe DA.  Permeability classification of representative fluoroquinolones by a cell culture method.  AAPS PharmSci. 6(2): article 13, 2004.

Volpe DA, LoRusso PM, Foster BJ, Parchment RE.  In  vitro  and  in  vivo  effects  of  acetyldinaline on  murine  megakaryocytopoiesis. Cancer Chemother. Pharmacol.  54:89-94, 2004.

Yu, LX, Lionberger, RA, Raw, AS, D’Costa, R, Wu, H, Hussain, AS: Applications of process analytical technology to crystallization processes. Adv. Drug Delivery Rev. 56(3): 349-369, 2004.

Yu, LX, Straughn, A B, Faustino, PJ, Yang, Y, Parekh, A, Ciavarella, AB, Asafu-Adjaye, E, Mehta, MU, Conner, DP, Lesko, LJ, Hussain, AS, The Effect of Food on the Relative Bioavailability of Rapidly Dissolving Immediate-Release Solid Oral Products Containing Highly Soluble Drugs, Mol. Pharm., 1(5), 357-362, 2004.

Yu, LX, Carlin, AS, Amidon, GL, Hussain, AS: Feasibility studies of utilizing disk intrinsic dissolution rate to classify drugs. Int. J. Pharm. 270(1-2): 221-7, 2004.

Back to Top


Asafu-Adjaye, EB, Wong, SK: Determination of ginsenosides (Ginseng Saponins) in dry root powder from Panax ginseng, Panax quinquefolius L., and selected commercial products by liquid chromatography: Interlaboratory study, J. AOAC Int. 86 (6): 1112-1123, 2003.

Lyon, RC, Jefferson, EH, Ellison, CD, Buhse, LF, Spencer, JA, Nasr, MM, Hussain, AS: Exploring Pharmaceutical Applications of Near-Infrared Technology. Am. Pharm. Rev., 6 (2): 64-70, 2003.

Sharpless, KE, Sander, LC, Wise, SA, NguyenPho, A, Lyon, RC: Development of Standard Reference Materials for Botanical Products. Inside Lab. Mgmt., May/June, 37-42, 2003.

Volpe DA, Ellison CD, Parchment RE, Grieshaber, CK, Faustino PJ: Effects of amitriptyline and fluoxetine upon the in vitro proliferation of tumor cells. J. Exp. Ther. Oncol. 3 (4) 169-84, 2003.

Volpe, DA, Warren, MK.  Myeloid clonogenic assays for comparison of the in vitro toxicity of alkylating agents.  Toxicol. In Vitro.  17:271-277, 2003

Back to Top

Book Chapters


Shah RB and Khan MA. Nanopharmaceuticals: Challenges and regulatory overview. In Nanotechnology in Drug Delivery, DeVilliers M (Editor), New York: Springer, in press, 2008.

Volpe, DA, Drug absorption studies in regulatory biowaiver applications.  In Preclinical Biopharmaceutics- In Situ, In Vitro and In Silico Tools for Drug Absorption Studies. Edited by C. Ehrhardt, K.J. Kim, Springer, pp. 665-680, 2008.


V. Kumar, M. Khan, and I. Reddy, Ocular, Nasal, and Otic Drug Delivery in the book Gibaldi’s Drug Delivery Systems in Pharmaceutical Care, Edited by Milo Gibaldi, Mary Lee, and Archana Desai, APhA. 2007.


Mansoor A. Khan and Fakhrul Ahsan. “Drug Permeability And Absorption From Non-Invasive Routes” in the book Preclinical Drug Development. Ed. Mark Rogge and David Taft, Marcel Dekker Inc., NY, USA. 2006

Ng, L, Lunn, G, Faustino, P: “Organic Impurities in Drug Substance: Origin, Control and Measurement.” Ed. Smith and Webb, Blackwell Publishing, London, November 2006.


Yu, LX, Ellison, CD, Hussain AS: Predicting Human Oral Bioavailability Using In Silico Models, in “Applications of Pharmacokinetic Principles in Drug Development”, Rajesh Krishna, ed., Plenum Pub Corp, 2003.