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Dissolution Test Links and Resources |
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Dissolution Papers
and Presentations
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Biopharmaceutics Classification System: Highlights of the FDA's Draft
Guidance", Office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 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)
Suppliers
Agilent
Distek, Inc.
Erweka
Hanson Research Corporation
Sotax
VanKel
Zymark
