Vivian A. Gray, James C. Mann, Richard Barker, and Xavier J. H. Pepin, The Case for Physiologically Based Biopharmaceutics Modelling (PBBM): What do Dissolution Scientists Need to Know?, Dissolution Technologies, 2020, Vol. 27 (3), 6-198.
Vivian Gray and Tom Rosanske, Dissolution, Chapter 18 in the book titled, Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, Edited by Christopher M. Riley, Thomas W. Rosanske, and George L. Reid, published by Elsevier, 2020.
W. Brown, V. Gray, J. Krämer, J. Mauger, and K. Warner, Comment on the Importance of Documenting Drug Solubility Measurement Methodology, Including Characterizing the Physical Form of the Solute, for Meaningful Understanding, Interpretation, and Reporting of Solubility Data, Dissolution Technologies, 2019, Vol. 26 (4), 6-8.
Gray, V. A. , Regulatory Aspects, Chapter 10 in the book titled, In Vitro Drug Release of Special Dosage Forms, Editors N. Fotaki and S. Klein, published by John Wiley and Sons, Inc., England, 2019.
Gray, V. A. (2019). Pharmaceutical Analysis | Dissolution Testing. In Worsfold, P., Poole, C., Townshend, A., Miró, M., (Eds.), Encyclopedia of Analytical Science, (3rd ed.). vol. 8, pp 182–187, Elsevier.
Vivian Gray, Susan Cady, David Curran, James DeMuth, Okponanabofa Eradiri, Munir Hussain, Johannes Krämer, John Shabushnig, Erika Stippler, In Vitro Release Test Methods for Drug Formulations for Parenteral Applications, USP Pharmacopeial Forum 44 (6) November 2018 and Dissolution Technologies, 2018, 25(4), 8-13.
Gray, V.A., Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes, AAPS PharmSciTech (2018). https://doi.org/10.1208/s12249-018-1197-7.
Vivian A. Gray, Pharmaceutical Analysis: Dissolution Testing, Reference Module in Chemistry, Molecular Sciences and Chemical Engineering, Elsevier, 2018.
Angel T. Alvarado, Vivian Gray, Ana María Muñoz, María Saravia, María R. Bendezú, Haydee Chávez, Jorge A. García, Roberto Ybañez-Julca, Andres Chonn-Chang, Patricia Basurto, Mario Pineda-Pérez, and Alberto Salazar, “Review: Application of Bioequivalence Testing of Medicines in Peru”, Dissolution Technologies, 2022, Vol. 29 (4), 220-226.
Raymond Skwierczynski, Vivian Gray, and James De Muth, “Overview of the activities of the USP Expert Panel on New Advancements in Product Performance Tests”, USP Pharmacopeial Forum 48 (3) May 2022 and Dissolution Technologies, 2022, Vol. 29 (3), 121-129.
Vivian Gray, “Dissolution Testing in the Pharmaceutical Laboratory”, Chapter 7 in the book titled, Analytical Testing for the Pharmaceutical GMP Laboratory, Edited by Kimberly Huynh-Ba, published by Wiley, 2022.
Vivian A. Gray, James C. Mann, Richard Barker, and Xavier J. H. Pepin, “The Case for Physiologically Based Biopharmaceutics Modelling (PBBM): What do Dissolution Scientists Need to Know?”, Dissolution Technologies, 2020, Vol. 27 (3), 6-19.
Vivian Gray and Tom Rosanske, “Dissolution”, Chapter 18 in the book titled, Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, Edited by Christopher M. Riley, Thomas W. Rosanske, and George L. Reid, published by Elsevier, 2020.
W. Brown, V. Gray, J. Krämer, J. Mauger, and K. Warner, “Comment on the Importance of Documenting Drug Solubility Measurement Methodology, Including Characterizing the Physical Form of the Solute, for Meaningful Understanding, Interpretation, and Reporting of Solubility Data”, Dissolution Technologies, 2019, Vol. 26 (4), 6-8.
Gray, V. A. , “Regulatory Aspects”, Chapter 10 in the book titled, In Vitro Drug Release of Special Dosage Forms, Editors N. Fotaki and S. Klein, published by John Wiley and Sons, Inc., England, 2019.
Gray, V. A. (2019). Pharmaceutical Analysis | Dissolution Testing. In Worsfold, P., Poole, C., Townshend, A., Miró, M., (Eds.), Encyclopedia of Analytical Science, (3rd ed.). vol. 8, pp 182–187, Elsevier.
Vivian Gray, Susan Cady, David Curran, James DeMuth, Okponanabofa Eradiri, Munir Hussain, Johannes Krämer, John Shabushnig, Erika Stippler, “In Vitro Release Test Methods for Drug Formulations for Parenteral Applications”, USP Pharmacopeial Forum 44 (6) November 2018 and Dissolution Technologies, 2018, 25(4), 8-13.
Gray, V.A., “Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes”, AAPS PharmSciTech (2018). https://doi.org/10.1208/s12249-018-1197-7.
Vivian A. Gray, Pharmaceutical Analysis: Dissolution Testing☆, Reference Module in Chemistry, Molecular Sciences and Chemical Engineering, Elsevier, 2018.
R. E. Stevens, V. Gray, A. Dorantes, L. Gold, and L. Pham, “Scientific and Regulatory Standards for Assessing Product Performance Using the Similarity Factor, f2.”, AAPS Journal, 2015.
V. Gray, E. Cole, J. Toma, L. Ghidorsi, J. Guo, J Han, F. Han, C. Hosty, J.Kochling, J. Kraemer, T. Langdon, S. Leinbach, G. Martin, S. Meyerhoffer, R. Moreton, K. Raghavan, E. Shneyvas, J. Suggett, S. Tindal, M. Vudathala, H. Wang, O. Anand, Z. Gao, R. Shah, L. Xia, J. Fotso, M. Hussain, V. Schmidt, T. Ghosh, N. Davydova, W. Brown, J. Fringer, E. Stippler, T. Eranui, M. Marques, “ Use of Enzymes in the Dissolution Testing of Gelatin Capsules and Gelatin-Coated Tablets — Revisions to Dissolution <711> and Disintegration and Dissolution of Dietary Supplements <2040>”, USP Pharmacopeial Forum 40 (6) November 2014 and Dissolution Technologies, 2014, 21(4), 6-9.
R. Skwierczynski, P. Curry, V. Gray, J. Kraemer, E. Stippler, J. Suggett, T. Mirza, and W. Brown, “Revision of the Dissolution Procedure: Development and Validation <1092>”, Dissolution Technologies, 2014, Vol. 21 (1), 6-12.
Vivian Gray and Tom Rosanske, “Dissolution”, Chapter 12 in the book titled, Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Edited by Christopher M. Riley, Thomas W. Rosanske and Shelley R. Rabel Riley, published by Elsevier, 2014; pp 245–263.
N. Fotaki, W. Brown, J. Kochling, Hitesh Chokshi, Mai Miao, Kin Tang, and V. Gray, “Rational for Selection of Dissolution Media: Three Case Studies”, Dissolution Technologies, 2013, Vol. 20 (3), 6-13.
G. Martin and V. Gray, “General Considerations for Dissolution Methods: Development, Validation, and Transfer”, JVT, 2011, Vol. 17, Number 1, 8-11.
G. Martin and V. Gray, “Selection of Dissolution medium for QC Testing of Drug Products”, GXP, 2011, Vol. 15, Number 4, 29-34.
G. Martin and V. Gray, “Potential Pitfalls when Performing Dissolution Instrument Qualification”, GXP, 2011, Vol. 15, Number 1, 6-12.
G. Martin and V. Gray, “Addressing Compliance Concerns during Dissolution Method Development, Validation and Transfer”, JGXP, 2011, Vol 15, Number 3, pages 11-16.
S. D’Souza, R. Lozano, S. Mayock, V. Gray, “AAPS Workshop on the Role of Dissolution in QBD and Drug Product Life Cycle: A Commentary”, Dissolution Technologies, 2010, Vol. 17 (4), 41-45
G. Martin and V. Gray, “Dissolution Instrument Qualification”, JVT, 2010, Vol. 16, Number 4, 10-16.
M. Marques, E. Cole, D. Kruep, V. Gray, D. Murachanian, W. Brown, G. Giancaspro, “Liquid-filled Gelatin Capsules”, Pharmacopeial Forum, 2009, Vol. 35 (4), 1029-1041
V. Gray, T. Mirza, R. Lozano, C. Tong, R. Löebenberg, B. Nickerson, Q. Wang, “Role of Dissolution in Drug Development Continuum”, Pharmaceutical Technologies, April , 2009.
V. Gray, G. Kelly, M. Xia, C. Butler, S. Thomas, S. Mayock, “Expert Review- The Science of USP 1 and 2 Dissolution: Present Challenges and Future Relevance”, Pharm. Research, on-line Jan. 2009, http://www.springerlink.com/content/4863020493817088/fulltext.pdf., Spring 2009.
Vivian Gray, Jack Zheng, and Norman Sesi, “In Vitro Dissolution and Method Development”, chapter in the book titled, Formulation and Analytical Development for Low-Dose Oral Drug Products. Edited by Jack Zheng, published by John Wiley and Sons, Hoboken, NJ, 2009. ISBN: 978047005609.
Vivian Gray, “Dissolution and Drug Release Testing”, chapter in the book titled, Pharmaceutical Dosage Forms: Tablets, Third Edition, Volume 3: Manufacture and Process Control. Edited by Larry Augsburger and Stephen Hoag, published by Informa Healthcare, New York, NY, 2008. ISBN: 9780849390166.
V. A. Gray, A.J. Hickey, et al, “The Inhalation Ad Hoc Panel for the USP Performance Tests of Inhalation Dosage Forms”, Pharmacopeial Forum, 2008, 34 (4), 1068-1074.
Anthony Palmieri and Vivian Gray, “Dissolution of Heterogeneous Dosage Forms”, chapter in the book titled, Dissolution Theory, Methodology, and Testing, edited by A. Palmieri, published by Dissolution Technologies, Hockessin, DE, 2007. ISBN 0-9761519-1-X.
M.N. Martinez, P Bonate, R.L. Chapman, A. DeGroot, S. D’Souza, N. Ghilazi, V. Gray, V. K. Gupta, K. Huynh-Ba, S. Iyer, A. Jayatilaka, A. Joshi, H.T. Karnes, M. Khan, P. Liu, C. Lunte, C. R. McCurdy, M. E. Morris, K. J. Norris, P. Ramsey, Sanjay Sehgal, “2007 Highlights of Advances in the Pharmaceutical Sciences: An American Association of Pharmaceutical Scientists (AAPS) Perspective, The AAPS Journal, 2007, Article 024, June.
Vivian Gray, “Challenges to the Dissolution Test, Including Equipment Calibration”, 2006, Pharmaceutical Technology, Analytical Methods Primer, 4-13. Subsequently republished in Dissolution Technologies, 2006, 13(2), 6-9, and Pharmaceutical Canada, 2006, 7 (2), 13-16.
Royal Hanson and Vivian Gray, “Handbook for Dissolution Testing”, Third Edition, 2004, Dissolution Technologies, Inc., Hockessin, DE.
Qingxi Wang and Vivian Gray, “HPLC in Dissolution Testing”, Chapter for the book, Handbook of Pharmaceutical Analysis by HPLC, Volume 6 of the Separation Science and Technology Series, Elsevier Academic Press, USBN 0-12-088547-6. 2005
Mauger J, Ballard J, Brockson R, De S, Gray V, Robinson D, “Intrinsic Dissolution Performance Testing of the USP Dissolution Apparatus 2 (Rotating Paddle) Using Modified Salicylic Acid Calibrator Tablets: Proof of Principal”, Dissolution Technologies, 10 (2), August 2003, 6-15.
Vivian Gray, “Dissolution Testing Using Fiber Optics – A Regulatory Perspective, American Pharmaceutical Review, Volume 6 (2), 2003, 26-30 and Dissolution Technologies, Volume 10 (4), November 2003.
Vivian Gray, “Fiber Optics Update”, posted on Internet website, www.dissolutionsolutions.net, March 2003.
Vivian Gray, “Dissolution Testing -- Good Manufacturing Practices”, European Pharmaceutical Review, 1 (2003), 58-61.
Vivian Gray, “Compendial Testing Equipment: Calibration, Qualification, and Sources of Error’, a Chapter in the book titled Pharmaceuticals Dissolution Testing, Published by Taylor and Francis. ISBN 0-8247-5467-0 , 2005.
Jeffrey Hofer, and Vivian Gray., “Examination of Selection of Immediate Release Dissolution Acceptance Criteria”, Pharmacopeial Forum, Volume 29 Number 1, 2003 and Dissolution Technologies, Volume 10 (1), 2003, 16-20.
Vivian Gray, “Let’s Talk Fiber Optics”, posted on Internet website, www.dissolutionsolutions.net, September 2002.
Vivian Gray, and Brent Miller, “Current Good Manufacturing Practices in the Dissolution Laboratory”, Pharmaceutical Canada, Volume 3 Number 3, 2002.
Vivian Gray, “Identifying Sources of Error in Calibration and Sample Testing”, American Pharmaceutical Review, summer 2002.
Vivian Gray, Mary Beggy, Robert Brockson, Nancy Corrigan and John Mullen, ”A Comparison of Dissolution Results using O-ring versus Clipped Basket Shafts”, Dissolution Technologies, Volume 8, Issue 4, Nov. 2001.
Vivian A. Gray, DuPont Pharmaceuticals Company (USP Biopharmaceutics Committee), Cynthia K. Brown, Quintiles, Inc., Jennifer B. Dressman, J.W. Goethe University, Lewis J. Leeson, LJL Associates, Inc. (USP Biopharmaceutics Committee). "A New General Chapter on Dissolution", Pharmacopeial Forum, Volume 27, Number 6, 2001.
Vivian A. Gray, "Basic Dissolution Testing". Published as an AAPS Short Course, on CD-ROM (Microsoft Power Point electronic format). 2001
PhRMA Subcommittee on Dissolution Calibration: Steve Brune (Pfizer); Jim Bucko (Eli Lilly); Sally Emr (Ortho-McNeil); Vivian A. Gray (DuPont Pharmaceutical Co.); Kathy Hippeli (Schering Plough); Al Kentrup (Hoescht Marion Roussel); Dave Whiteman (Hoescht Marion Roussel); Mark Loranger (Boeringer Ingelheim); Mary Oates, Chairperson (Warner Lambert), "Dissolution Calibrator: Recommendations for Reduced Chemical Testing and Enhanced Mechanical Calibration", Pharm. Forum, 2000, 26(4), 1149-1166.
Aubry, A. F.; Sebastian, D.; Hobson, T.; Xu, J. Q. and Gray, V. A., “In-Use Testing of Extemporaneously Prepared Suspension of New Non-nucleoside Reversed Transcriptase Inhibitors In Support of Phase I Clinical Studies”, J. Pharm. and Biomed. Anal., 23 (2000), 535-542.
Members of the Gelatin Capsule Working Group, "Collaborative Development of Two-Tier Dissolution Testing for Gelatin Capsules and Gelatin-Coated Tablets Using Enzyme-Containing Media", Pharm. Forum, 1998, 24(5), 7045-7050.
Gray, V.A., “Two-Tier Dissolution Testing”, Dissolution Technologies, May, 1998, 5(2).
Gray, V.A., “Report on the USP Dissolution and Bioavailability Subcommittee Activity Regarding the Peak Vessel”, Dissolution Technologies, Feb. 1998, from Roundtable Conference at AAPS meeting in Boston, MA, November, 1997
Gray, V.A. and Foster, T.S., “Utility of USP Salicylic Acid Calibrator Tablets”, Pharm. Forum 1997, 23(6).
Gray, V.A. and Grady, L.T., “USP Dissolution Standards--Revisions, Initiatives and New Policies Since 1980”, Pharm Forum, 1997, 23(3), 4183-4197.
Okeke, C.C.; Barletta, F.P.; Gray, V.A.; Krasowski, J.A.; Paul, W.L.; Belson, J.J. and Grady, L.T., “USP Standards and Activities Affecting Pharmacy Practice,” Am. J. Health-Syst. Pharm., 1997, 54.
Foster, T.S. and Gray, V.A., “USP Dissolution <711>, Pooled Sampling--Response to Comments Received”, Pharm. Forum, 1997, 23(3), 4248-4249.
Gray, V.A. and Rippere, R.A., “Labeling Issues for Recently Approved Abbreviated New Drug Applications for Extended-release Products”, Pharm. Forum, 1996, 22(1), 1942.
Gray, V.A. and Dressman, J.B., “Change of pH Requirements for Simulated Intestinal Fluid TS”, Pharm. Forum, 1996, 22(1), 1943-1945.
Gray, V.A. and Lovering, E.G., “Other Impurities Proposal--The 0.1% Level in Foreign Substances and Impurities”, Pharm. Forum, 1995, 21(6), 1650-1653.
Achanta, A.S.; Gray, V.A.; Cecil, T.L. and Grady, L.T., “Evaluation of the Performance of Prednisone and Salicylic Acid USP Dissolution Calibrators,” Drug Development and Industrial Pharmacy, 1995, 21(10), 1171-1182.
Gray, V.A., Hubert, B.B. and Krasowski, J.A., “Calibration of Dissolution Apparatus 1 and 2--What to do When Your Equipment Fails”, Pharm. Forum, 1994, 20(6), 8571-8573.
Gray, V.A. “Drug Release Calibrators for Apparatus 3—Collaborative Study Results”, Pharm. Forum, 1994, 20(1), 6943-6943.
Taborsky-Urdinola, C.J.; Gray, V.A. and Grady, L.T., “Effects of Packaging and Storage on the Dissolution of Model Prednisone Tablets”, J. of Hosp. Pharm., 1981, 38, 1322-1327.
Thakker, K.D.; Naik, N.C.; Gray, V.A. and Sun, S., “Fine-Tuning of Dissolution Apparatus for Apparatus Suitability Test Using the USP Dissolution Calibrators”, Pharm. Forum, 1980, 6(4).
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