Drug stability : principles and practices
著者
書誌事項
Drug stability : principles and practices
（Drugs and the pharmaceutical sciences, v. 107）
Marcel Dekker, c2001
3rd ed., rev. and expanded
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注記
Includes bibliographical references and indexes
内容説明・目次
内容説明
Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.
目次
- Solution kinetics
- kinetic pH profiles
- oxidation in solution
- catalysis, complexation, and photolysis
- solid state stability
- interactions of moisture with solids
- physical characterisation of solids
- preformulation
- physical testing
- development and validation of HPLC stability-indicating assays
- stability testing of clinical trial materials
- a rational approach to stability testing and analytical development for NCE, drug substance, and drug products marketed product stability testing
- packaging, package evaluation, stability, and shelf-life
- industrial stability testing in the United States and computerisation of stability data
- stability of polypeptides and proteins
- regulatory aspects of stability toting in Europe
- regulatory and scientific aspects of stability testing - present and possible future trends.
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