Pharmaceutical dissolution testing /
Pharmaceutical dissolution testing /
edited by Jennifer Dressman and Johannes Kraemer.
- New York : London : Marcel Dekker ; Taylor & Francis [distributor], 2005.
- 412 p. : ill.
Includes bibliographical references and index.
1.Historical development of dissolution testing -- 2.Compendium testing equipment: calibration, qualification, and sources of error -- 3.Compendial requirements of dissolution testing - European pharmacopoeia, Japanese pharmacopeia -- 4.The role of dissolution testing in the regulation of pharamceuticals: the FDA perspective -- 5.Gastrointestinal transit and drug absorption -- 6.Physiological parameters relevant to dissolution testing: hydrodynamic considerations -- 7.Development of dissolution tests on the basis of gastrointestinal physiology -- 8.Orally administered drug products: dissolution data analysis with a view to in vitro-in vivo correlation -- 9.Interpretation of in vitro-in vivo time profiles in terms of extent, rate and shape -- 10.Study design considerations for IVIVC -- 11.Dissolution method development with a view to quality control -- 12.Dissolution method development: an industry perspective -- 13.Design and qualification of automated dissolution systems 14.Bioavailability of ingredients in dietary supplements: a practical approach to the in vitro demonstration of the availability of ingredients in dietary supplements.
This reference provides information on equipment, equipment qualification, consideration of the gastrointestinal physiology in test design and the analysis and interpretation of data and procedure automation.
9780824754679 (hbk.) : £97.00 9780824754679
Drugs--Solubility--Testing
Health and Wellbeing.
Pharmaceutical chemistry & technology
RS189 / .P446 2005
615.19 DRE
Includes bibliographical references and index.
1.Historical development of dissolution testing -- 2.Compendium testing equipment: calibration, qualification, and sources of error -- 3.Compendial requirements of dissolution testing - European pharmacopoeia, Japanese pharmacopeia -- 4.The role of dissolution testing in the regulation of pharamceuticals: the FDA perspective -- 5.Gastrointestinal transit and drug absorption -- 6.Physiological parameters relevant to dissolution testing: hydrodynamic considerations -- 7.Development of dissolution tests on the basis of gastrointestinal physiology -- 8.Orally administered drug products: dissolution data analysis with a view to in vitro-in vivo correlation -- 9.Interpretation of in vitro-in vivo time profiles in terms of extent, rate and shape -- 10.Study design considerations for IVIVC -- 11.Dissolution method development with a view to quality control -- 12.Dissolution method development: an industry perspective -- 13.Design and qualification of automated dissolution systems 14.Bioavailability of ingredients in dietary supplements: a practical approach to the in vitro demonstration of the availability of ingredients in dietary supplements.
This reference provides information on equipment, equipment qualification, consideration of the gastrointestinal physiology in test design and the analysis and interpretation of data and procedure automation.
9780824754679 (hbk.) : £97.00 9780824754679
Drugs--Solubility--Testing
Health and Wellbeing.
Pharmaceutical chemistry & technology
RS189 / .P446 2005
615.19 DRE