Stability testing in the EC, Japan and the USA : scientific and regulatory requirements (including the draft of the harmonized guideline for the EC, Japan and the USA) /
Stability testing in the EC, Japan and the USA : scientific and regulatory requirements (including the draft of the harmonized guideline for the EC, Japan and the USA) /
edited by Wolfgang Grimm and Kurt Krummen.
- 272 pages : illustrations ; 23 cm.
- Paperback APV ; Bd. 32 .
- Paperback APV ; Bd. 32. .
Includes bibliographical references.
Basic principles of stability testing/W. Grimm--Characterization and improvement of the stability behaviour of drug substances/P.H. Stahl,--Excipient compatibility, possibilities and limitations in stability prediction/D.C. Monkhouse--Prediction of the stability of drug products, new techniques and strategies/K.D. Gneuss--A critical review of HPLC, SFC and CZE in drug analysis/W. Steuer--Influence of packaging material on the stability of drug products/K. Krummen--Plastics for drug products: analysis, possible interactions and official requirements/F. Pellerin--EC guidelines for stability tests on active substances and finished products/A.C. Cartwright--The revised Japanese guidelines for stability studies/Y. Takeda--Consideration on revision of the FDA guideline for submitting documentation on the stability of human drugs and biologics/C. Kumkumian--Stability testing in relation to guidelines in the EC, Japan and USA, a recommendation/H. Moeller--The tripartite guideline for the stability testing of new active drug substances and products/T. Beaumont--General concept of stability testing/W. Grimm--Cyclodextrines: structure application, stability and their influence on the stability of drug substances/L. Szente--Stability and stability testing of drug products derived by recombinant DNA technology/H. Hoffmann.
3804712150
Drug stability--Standards--European Economic Community countries.
Drug stability--Standards--Japan.
Drug stabiltiy--Standards--United States.
Excipients--congresses.
Cyclodextrins.
Recombinant Proteins.
Polymers.
615.1901 / S
Includes bibliographical references.
Basic principles of stability testing/W. Grimm--Characterization and improvement of the stability behaviour of drug substances/P.H. Stahl,--Excipient compatibility, possibilities and limitations in stability prediction/D.C. Monkhouse--Prediction of the stability of drug products, new techniques and strategies/K.D. Gneuss--A critical review of HPLC, SFC and CZE in drug analysis/W. Steuer--Influence of packaging material on the stability of drug products/K. Krummen--Plastics for drug products: analysis, possible interactions and official requirements/F. Pellerin--EC guidelines for stability tests on active substances and finished products/A.C. Cartwright--The revised Japanese guidelines for stability studies/Y. Takeda--Consideration on revision of the FDA guideline for submitting documentation on the stability of human drugs and biologics/C. Kumkumian--Stability testing in relation to guidelines in the EC, Japan and USA, a recommendation/H. Moeller--The tripartite guideline for the stability testing of new active drug substances and products/T. Beaumont--General concept of stability testing/W. Grimm--Cyclodextrines: structure application, stability and their influence on the stability of drug substances/L. Szente--Stability and stability testing of drug products derived by recombinant DNA technology/H. Hoffmann.
3804712150
Drug stability--Standards--European Economic Community countries.
Drug stability--Standards--Japan.
Drug stabiltiy--Standards--United States.
Excipients--congresses.
Cyclodextrins.
Recombinant Proteins.
Polymers.
615.1901 / S