Invited Speaker:
Vivian Gray, “Challenges when developing a discriminatory dissolution method and aspects of
method validation”, Approaches, regulatory challenges, and advances in bioequivalence,
dissolution testing and biowaivers Workshop, presented by AAPS In Vitro Release and
Dissolution Testing Community and sponsored by College of Pharmacy at the University of the
Philippines Manila. The talk was presented virtually on February 22, 2023.
Vivian Gray, “Challenges when developing a discriminatory dissolution method”, A quest for
biowaivers, including next generation dissolution characterization and modeling Workshop,
sponsored by AAPS and Jagiellonian University Medical College, presented virtually on
November 16, 2022.
Vivian Gray, “Harmonization of CMC area of dissolution, EU/US perspectives, including new
FDA guidances and USP Chapters and Monographs”, Disso India 2020 – online international
conference, on May 4, 2020
Vivian Gray, “History of Dissolution Performance Testing", USP Expert Panel Meeting, USP
Rockville, MD, December 12, 2020.
Vivian Gray, “The role of dissolution for generic drugs”, Dissolution Testing, Biowaivers, and
Bioequivalence Workshops, Sponsored by AAPS and Peruvian College of Pharmacists,
presented in Lima, Cusco and Ayacuchu, Peru, on May 3, 6, and 9, 2019.
Vivian Gray, “FDA requirements in dissolution testing for evaluation and approval of generics
drugs for solid oral dosage forms”, Dissolution Testing, Biowaivers, and Bioequivalence
Workshops, Sponsored by AAPS and Peruvian College of Pharmacists, presented in Lima, Cusco
and Ayacuchu, Peru, on May 3, 6, and 9, 2019.
Vivian Gray, “Harmonization of CMC area of dissolution, EU/US perspectives, including new
FDA guidances and USP Chapters and Monographs”, Dissolution Testing, Biowaivers, and
Bioequivalence Workshops, Sponsored by AAPS and Peruvian College of Pharmacists,
presented in Lima, Cusco and Ayacuchu, Peru, on May 4, 7, and 10, 2019.
Vivian Gray, “Challenges in Dissolution Method Development for Implants, Stents, and Non-
Conventional Suspensions”, DIA/AAPS CMC workshop, Rockville, MD, April 24, 2017.
Vivian Gray, “Basic Dissolution Method Development and Validation”, Lecture 2 of the AAPS
eCourse Dissolution for Solid Oral Dosage Forms, 2016.
Vivian Gray, “FDA Requirements in Dissolution Testing for Evaluation and Approval of Generic
Drugs in Solid Oral Dosage Forms, Including Similarity Factor”, Dissolution Testing,
Biowaivers, and Bioequivalence AAPS and NIFDC Workshop, Tianjin, China, June 21, 2016.
Vivian Gray, “Differences and Harmonization of CMC area of dissolution, EU/US perspectives”,
Dissolution Testing, Biowaivers, and Bioequivalence AAPS and NIFDC Workshop, Tianjin,
China, June 22, 2016.
Vivian Gray, “In Vitro Equivalence—Is Harmonization Actually Possible”, AAPS Annual
Meeting, Orange Convention Center, Orlando, USA, October 26, 2015.
Vivian Gray, ”Method development and setting clinically relevant dissolution specifications,
including quality by design”, Profiling of Drug Dissolution,
Pharmacokinetics and Pharmacodynamics Workshop, Kuala Lumpur Convention Center,
Malaysia, September 2, 2015.
Vivian Gray, ”Gelatin Capsules: Current issues when crosslinking is observed, related to the
addition of enzyme to media”, Profiling of Drug Dissolution, Pharmacokinetics and
Pharmacodynamics Workshop, Kuala Lumpur Convention Center, Malaysia, September 3, 2015.
Vivian Gray, “Comparison of Dissolution Profiles, including Bioequivalence and F2”, Eastern
Analytical Symposium, Somerset, NJ, USA, November 17, 2014.
Vivian Gray, “Role of Dissolution Testing in Drug Development”, Webinar for Mercer Pharmacy
Students, May 28, 2014.
Vivian Gray, “USP Anticipated Revisions to Dissolution General Chapter <711> and <1094>
General Chapter on Capsules”, Dissolution of Capsules Workshop, USP, Rockville, MD, USA,
March 26, 2014.
Vivian Gray, “Scientific Considerations using Similarity Factor, F2”, AAPS Annual Meeting,
San Antonio, TX, USA, November 12, 2013.
Vivian Gray, “Design of Experiments (DoE) for the Dissolution Test Methodology and Detection
of Critical Quality Attributes”, Drug Development and Registration: Pharma-2020 Strategy
Realization Conference, Moscow, Russia, October 29, 2013.
Vivian Gray, “Gelatin Capsules: Current Issues when Cross-linking is Observed, Related to
Addition of Enzyme to Media”, Drug Development and Registration: Pharma-2020 Strategy
Realization Conference, Moscow, Russia, October 29, 2013.
Vivian Gray, “Need for harmonized IVIVC Guidances to Expedite Global Approvals”, Annual
Controlled Release Society, Honolulu, HI, USA, July 20, 2013.
Vivian Gray, “Method Development and Setting Clinically Relevant Dissolution Specifications,
Including Quality by Design”, AAPS Workshop on Dissolution Testing and Bioequivalence,
National University of La Plata, La Plata, Argentina, March 7, 2013.
Vivian Gray, “Analytical issues Related to Enzymes Addition when Crosslinking Occurs”,
AAPS Annual Meeting, Chicago, IL, October 18, 2012.
Vivian Gray, “Setting Clinically Relevant In Vitro Release Specifications for Controlled Release
Products”, Annual Controlled Release Society, Quebec City, Canada, July 14, 2012.
Vivian Gray, “Report on Activities of USP Panels on Use of Enzymes in Testing Capsules that
are Crosslinked”, Challenges of Dissolution Testing Workshop, USP, Rockville, MD, June 11,
2012.
Vivian Gray, “Comparison of Dissolution Profiles in Validation, Method Transfer and F2”,
presented at the AAPS-Rhodes University Dissolution Workshop, Grahamstown, South Africa,
December 6, 2011
Vivian Gray, “General Concepts: Design of Dissolution Method Development, including Quality
by Design”, presented at the AAPS-Sechenov First Moscow State Medical University
Dissolution Workshop, Moscow, Russia, October 6, 2011.
Vivian Gray, “GMP’s in the Dissolution Laboratory, including Preparing for a PAI”, presented at
the AAPS-Sechenov First Moscow State Medical University Dissolution Workshop, Moscow,
Russia, October 7, 2011.
Vivian Gray, “General Concepts:_Design of Dissolution Method Development, including
Quality by Design”, presented at the AAPS-Croatian Pharmaceutical Society Dissolution
Workshop, Zagrab, Croatia, October 3, 2011.
Vivian Gray, “GMP’s in the Dissolution Laboratory, including Preparing for a PAI”, presented at
the AAPS-Croatian Pharmaceutical Society Dissolution Workshop, Zagrab, Croatia, October 4,
2011.
Vivian Gray, “Recent Challenges in Dissolution Testing, Including USP Initiatives”, Philadelphia
Pharmaceutical Forum, April, 2011
Vivian Gray, “Determining Similarity of Products- F2 Criterion and Variability of Dissolution
Test”, presented at the AAPS-Rhodes University Dissolution Workshop, Grahamstown, South
Africa, December 10, 2009.
Vivian Gray, “Trouble Shooting Dissolution Method Transfer Problems”, presented at the AAPS-
IPA workshop held in Bangalore, India, May 15, 2009.
Vivian Gray, “Dissolution Regulatory GMP Issues, Including Preparing for a PAI”, presented at
the AAPS-IPA workshop held in Bangalore, India, May 16, 2009.
Vivian Gray, “Dissolution Method Transfer, Including Sources of Problems”, presented at the
AAPS Annual Meeting, held in San Diego, CA, November 13, 2008.
Vivian Gray, “Current Challenges in Dissolution Testing, including the Role of QBD”,
Philadelphia Pharmaceutical Forum, October 9, 2008
Vivian Gray, “Dissolution Technology and Challenges for Novel Dosage Forms” and “Overview
of Dissolution Methods and Technologies”, presented at the AAPS/SFDA Joint Conference held
in Hangzhou, China, July 2, 2007.
Vivian Gray, “Update on Emerging Trends on Quality by Design and GMP issues”, presented at
the IPA conference on Dissolution Testing, held in Toronto, Canada, June 10, 2007.
Vivian Gray, “Dissolution Method Development, Including Poorly Soluble Drugs and Novel
Dosage Forms”, a one day course presented at the Eastern Analytical Symposium, held in
Somerset, NJ, on November 14, 2006.
Vivian Gray, “Challenges to the Dissolution Method”, presented at the Tablets and Capsules
Conference, held in Radison, NJ, on October 10, 2006.
Vivian Gray, “Challenges to the Dissolution Test, Including Performance Verification”, presented
at the USP Annual Meeting, held in Denver, Colorado, on September 29, 2006.
Vivian Gray, “Current Challenges to the Dissolution Test”, presented at the workshop “Forum on
Studying of Dissolution Testing in Japan”, held in Osaka and Tokyo, Japan, on June 16 and 22,
2006.
Vivian Gray, “Challenges to Dissolution Testing, Including Calibration, Rebuttal and Common
Ground”, presented at the AAPS Workshop on Challenges for Dissolution Testing for the 21 st
Century, held in Arlington, VA on May 3, 2006.
Vivian Gray, “Following GMP’s in the Dissolution Laboratory”, Presented at the Dissolution
Testing, Bioavailability & Bioequivalence Conference, held in Budapest, Hungary on May 22,
2006.
Vivian Gray, “Challenges in Developing Dissolution Methods for Novel dosage Forms”,
Philadelphia Pharmaceutical Forum, March 9, 2006.
Vivian Gray, ”Basic Dissolution Requirements” presented at the AAPS Sunrise School at the
AAPS Annual Meeting held in Nashville, TN on November 9, 2005.
Vivian Gray,” Future Challenges of the Dissolution Performance Test”, presented at the AAPS
Roundtable Symposium at the AAPS Annual Meeting held in Baltimore, MD, on November 10,
2004.
Vivian Gray, “Dissolution Method Development and Validation”, presented at the USP Annual
Meeting, held in Iselin, NJ, on September 28, 2004.
Vivian Gray, “Design and Calibration of Dissolution Test Equipment”, presented at the
FIP/WHO/CHINA Bioequivalence and Hands on Dissolution Workshop, held in Beijing, China
on April 12-13 and Shanghai, China on April 15-16 2004.
Vivian Gray, “Dissolution Testing with Fiber Optics: Industry Perspective on Regulatory
Aspects”, presented at the AAPS Workshop on Dissolution: New Technology and Regulatory
Initiatives held in Bethesda, MD on March 30, 2004.
Vivian Gray, “Dissolution Regulatory GMP Issues, Including Preparing for a PAI”, presented at
the Dissolution, Bioequivalence and Bioavailability Conference in Philadelphia on January 26,
2004.
Vivian Gray, “Solubility Considerations in Dissolution Method Development”, presented at the
Strategies for Improving Solubility Conference held in Brussels, Belgium on October 3, 2003.
Vivian Gray, “Method Validation in the Dissolution Lab” presented at the Dissolution,
Bioequivalence and Bioavailability Conference held in Brussels, Belgium October 2, 2003.
Vivian Gray, “Dissolution Specifications Industry Update”, presented at the Dissolution,
Bioequivalence and Bioavailability Conference in Brussels, Belgium October 3, 2003 and in
Philadelphia January 26, 2004.
Vivian Gray, “Challenges of Developing Dissolution Methods and In Vivo/In Vitro Correlations
for Poorly Soluble Drugs, Including a Discussion of Novel Dosage Forms”, presented at the
Dissolution, Bioequivalence and Bioavailability Conference in Philadelphia, PA on Feb. 3, 2003,
June 23, 2003, and in Brussels, October 3, 2003.
Vivian Gray, “Calibration and Qualification of Non-Compendial Dissolution Equipment,
Including Sources of Error’, presented at the Dissolution Innovation Conference held in Raleigh,
NC on August 5, 2003.
Vivian Gray, “Dissolution Testing with Fiber Optics: Regulatory Perspective and Evaluation
Tips”, presented at the Dissolution Innovation Conference held in Raleigh, NC on August 6,
2003.
Vivian Gray, “Dissolution Testing of Special Dosage Forms: Summary of FIP Workshops and
Publication”, presented at the Dissolution Innovation Conference held in Raleigh, NC on August
7, 2003.
Vivian Gray, “Dissolution Regulatory GMP Issues”, presented at the International
Pharmaceutical Academy Exposition 2002 in Toronto, Canada, on September 24, 2002.
Vivian Gray, “Calibration and Qualification—Mechanical and Tablet Calibration”, presented at
the AAPS/FDA Workshop on Dissolution/In Vitro Release Testing and Specifications for Special
Dosage Forms In Arlington, VA on September 16, 2002.
Vivian Gray, “Challenges in Developing Dissolution Methods and In Vivo and In Vitro
Correlations for Poorly Soluble Drugs”, presented at the 44 th Annual International Industrial
Pharmaceutical Research and Development Conference on Strategies for formulating poorly
soluble Drugs in Merrimac, Wisconsin on June 7, 2002.
Vivian Gray, “Recent Trends and Initiatives in Dissolution, Including Calibration”, Presented at
the DDG (Dissolution Discussion Group), in Chapel Hill, NC on May 23, 2002.
Vivian Gray, Mary Beggy, Robert Brockson, Gina Stick, “Oral Dosage Forms—General
Considerations: Calibration and Qualification”, Presented at Workshop sponsored by FIP,
“Dissolution Testing of Special Dosage Forms”, in Frankfurt, Germany on 05MAR01.
Vivian Gray, “Identifying Sources of Error and Variability and Sample Testing”, Presented at a
Dissolution Conference in Philadelphia, PA, 27FEB01.
Vivian A. Gray, John J. Mullen, and Robert W. Brockson,
“Encapsulated Tablets – Dissolution Testing Considerations”. Presented at Dissolution Testing
Conference, Vienna, VA, November 30 to December 1, 2000.
Vivian A. Gray and Munir Hussain, “Gelatin Cross-linking in Capsules and its Effect on
Dissolution, Including a Case Study”, Dissolution Testing Conference 2000, Philadelphia, PA.
Vivian A. Gray and Gina Leonard, “Overview of Semi-Automated Equipment in a Dissolution
Laboratory”, ISLAR, Boston, MA, 1999.
Vivian A. Gray, “Calibration of Apparatus I and II: What to do When Your Equipment Fails”,
Calibration and Validation Group, 1998.
Vivian A. Gray, “What Dissolution Can Do for You” DuPont Pharmaceuticals Company, 1998.
Vivian A. Gray, “USP Update: Chewable Tablets, Calibrator Tablets, Pooled Sampling, Two Tier
Testing, and Other Issues”, Philadelphia Pharmaceutical Forum, 1997
Vivian A. Gray, “Capsules Two Tier Dissolution Testing”, AAPS Southeast Regional Meeting,
1997
Vivian A. Gray, “Extended Release Standards”, Pharm Tech Conference, 1997.
Vivian A. Gray, “Dissolution Calibrators” AAPS Short Course on Dissolution, held at the AAPS
Annual Meeting in November, 1996.
Vivian A. Gray, “Dissolution Calibrators”, Zentrallaboratorium Deutscher Apotheker, held in
Frankfurt Germany in 1996.
Vivian A. Gray, “Dissolution Calibrators”, AAPS Dissolution Workshop held in Crystal City ,
MD on Sept. 26, 1995.
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