Dissolution Test Links and Resources
Carol Noory, Nhan Tran, Larry Ouderkirk, and Vinod Shah."Mechanical Versus Chemical Dissolution Calibration", United States Pharmacopeial Convention, Rockville, D
Tahseen Mirza, Ph.D. "Steps for Development of a Dissolution Test for Sparingly Water-Soluble Drug Products", Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD
Eleftheria Nicolaides(1), John M. Hempenstall(2) and Christos Reppas(1)."Biorelevant Dissolution Tests with the Flow-Through Apparatus?", (1)School of Pharmacy, University of Athens, Athens, Greece (2);Glaxo Wellcome R&D, Pharmaceutical Sciences, Hertfordshire, England
Vinod P. Shah and Roger L. Williams "Roles of Dissolution Testing: Regulatory, Industry and Academic Perspectives - Role of Dissolution Testing in Regulating Pharmaceuticals", Office of Pharmaceutical Science, Center for Drug Evaluation and Research Food and Drug Administration, Rockville, MD
Martin Siewert "Roles of Dissolution Testing: Regulatory, Industry and Academic Perspectives -Role of Dissolution Testing in Pharmaceutical Industry", Hoechst Marion Roussel, AG, Frankfurt, Germany
Jennifer B. Dressman "Roles of Dissolution Testing: Regulatory, Industry and Academic Perspectives -Future Directions for Academic Research in Dissolution Testing", Johann Wolfgang Goethe-University, Frankfurt/Main, Germany
John R. Crison "Developing Dissolution Tests for Modified Release Dosage Forms: General Considerations", PORT Systems, LLC
V. Fuerte (1) and M. Maldonado (2) "The Multicomponent Automated Dissolution System: An Alternative in the Development and Pharmaceutical Analysis of Generic Polydrugs", Centro de Investigacion y de Estudios, Avanzados del IPN. Tepepan, Mexico; (2) Department of Pharmacy, King's College London, United Kingdom
Mary Oates "Recent Innovations in Dissolution Calibration", Warner-Lambert, Morris Plains, NJ
Richard Hengst and Rolf Rollillow "Hollow ShaftTM Sampling Method for Dissolution Testing", Sotax Corporation, Furlong, PA
MEETING REPORT: "Challenges In the Design and Evaluation of Bioequivalence Studies" , 1998
A. S. Hussain, L.J. Lesko, K. Y. Lo, V.P. Shah, D. Volpe, and R. L. Williams "The Biopharmaceutics Classification System: Highlights of the FDA's Draft Guidance", Office of Pharmaceutical Science, CDER, FDA
Harnath Doddapaneni, John Jushchyshyn "Enhanced Decision Making from Dissolution Automation", SmithKline Beecham Pharmaceuticals Research & Development, Upper Merion, PA
Charles C. Collins, Ph.D., "VIBRATION: What Is It and How Might It Affect Dissolution Testing?", Duquesne University, Pittsburgh, PA
Huey Lin Ju and Shu-Jean Liaw, "On the asessement of similarity of Drug Dissolution Profiles", Drug Information Journal, Vol 31 pp. 1273-1289, 1997.
Shein-Chung Chow, "Good Statistics Practice in the Drug Development and Regulatory Approval Process", Drug Information Journal, Vol 31 pp. 1157-1166, 1997.
Shein-Chung Chow, "Pharmaceutical Validation and Process Controls in Drug Development", Drug Information Journal, Vol 31 pp. 1195-1201, 1997.
George Lukas, "Critical Manufacturing Parameters Influencing Dissoluton", Drug Information Journal, Vol 30 pp. 1091-1104, 1996.
David E Storey, "The Role of Dissolution Testing in The Design of Immediate Release Dosage Forms", Drug Information Journal, Vol 30 pp. 1039-1044, 1996.
Lee T. Grady, "Third Generation Dissolution Testing: Dissolution as a Batch Phenomenon", Drug Information Journal, Vol 30 pp. 1063-1070, 1996.
"Fip Guidelines for Dissolution Testing of Solid Oral Products (Final Draft, 1995)", Drug Information Journal, Vol 30 pp. 1071-1084, 1996.
Saeed A. Qureshi, "Calibration--The USP Dissolution Apparatus Suitability Test", Drug Information Journal, Vol 30 pp. 1055-1061, 1996.
Yi Tsong, Thomas Hammerstrom, Pradeep Sathe and Jen-Pei Liu, "Statistical Assessment of Mean Differences Between two Dissolution Data Sets", Drug Information Journal, Vol 30 pp. 1105-1112, 1996.
Vinod P. Shah, Yi Tsong, Pradeep Sathe and Roger L. Williams, "Methods to Compare Dissolution Profiles", Drug Information Journal, Vol 30 pp. 1113-1120, 1996.
James E. Polli, Singh Rekhi and Vinod P. Shah, "Dissolution Profile Comparison Using Similarity Factor, f2", Office of Pharmaceutical Science, Center for Drug Evaluation and Research Food and Drug Administration, Rockville, MD.
Ian J. Mcgil Veray, "Overview of Workshop: in Vitro Dissolution of Immediate Release Dosage Forms: Development of In Vivo Relevance and Quality Control Issues", Drug Information Journal, Vol 30 pp. 1029-1037, 1996.
Ginski, M.J., Taneja, R., and Polli, J.E. "Prediction of dissolution-absorption relationships from a continuous dissolution/Caco-2 system", PharmSci June 3, 1999.
Other Dissolution Related Sites
Dissolution Technologies
Dissolution.com
IVIVC - In Vitro / In Vivo Corporation
IVIVC - Dissolution Literature References
IVIVC.com (Biovista)
Controlled Release Drug Delivery Links
Controlled-Release Drug Delivery Systems
Dissolutions Real Science, Straightforward Solutions
Dissolution Discussion Groups
DDG - Dissolution Discussion Group
Dissolution related Guidelines
Note For Guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Quality) (CPMP - Draft) FDA - CDER Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997) FDA - CDER Oral Extended (Controlled) Release Dosage Forms in Vivo Bioequivalence and in Vitro Dissolution Testing FDA - CDER SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation FDA - CDER SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (Issued 1/1999) FDA - CDER SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Issued 10/6/1997) FDA - CDER SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Issued 5/1997) Note For Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP - Draft - CPMP/EWP/QWP/1401/98 ) FDA - CDER Food-Effect Bioavailability and Bioequivalence Studies (Issued 10/1997) FDA - CDER In Vivo Bioequiv. Studies Based on Population and Individual Bioequivalence Studies (Issued 12/10/1997) FDA - CDER Topical Dermatological Drug Product NDAs and ANDAs -- In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies (Issued 6/18/1998) FDA - CDER Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System (Issued 1/1999, Posted 2/16/1999) FDA - CDER Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design (Issued 7/1992, Posted 10/5/98) FDA - CDER Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Issued 6/1999, Posted 6/2/1999)
Note For Guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Quality) (CPMP - Draft)
FDA - CDER Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997)
FDA - CDER Oral Extended (Controlled) Release Dosage Forms in Vivo Bioequivalence and in Vitro Dissolution Testing
FDA - CDER SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
FDA - CDER SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (Issued 1/1999)
FDA - CDER SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Issued 10/6/1997)
FDA - CDER SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Issued 5/1997)
Note For Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP - Draft - CPMP/EWP/QWP/1401/98 )
FDA - CDER Food-Effect Bioavailability and Bioequivalence Studies (Issued 10/1997)
FDA - CDER In Vivo Bioequiv. Studies Based on Population and Individual Bioequivalence Studies (Issued 12/10/1997)
FDA - CDER Topical Dermatological Drug Product NDAs and ANDAs -- In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies (Issued 6/18/1998)
FDA - CDER Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System (Issued 1/1999, Posted 2/16/1999)
FDA - CDER Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design (Issued 7/1992, Posted 10/5/98)
FDA - CDER Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Issued 6/1999, Posted 6/2/1999)
Suppliers
Agilent Distek, Inc. Erweka Hanson Research Corporation Sotax VanKel Zymark
Agilent
Distek, Inc.
Erweka
Hanson Research Corporation
Sotax
VanKel
Zymark
