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060			_aQV 754 _b.D78 2000
245		0	_aDrug stability : _bprinciples and practices / _cedited by C.T. Rhodes, Jens T. Carstensen.
250			_a3rd ed., rev. and expanded.
260			_aNew York : _bMarcel Dekker, _c2000
300			_aVol.107, vii, 773 p.: _bill. _c26 cm.
490			_aDrugs and the pharmaceutical sciences
500			_aRev. ed. of: Drug stability / Jens T. Carstensen. 2nd ed., rev. and expanded. 1995.
504			_aIncludes bibliographical references (p. 99-100) and index.
505			_aIntroductory overview -- Solution kinetics -- Kinetic pH profiles -- Oxidation in solution -- Catalysis, complexation, and photolysis -- Solid state stability -- Interactions of moisture with solids -- Physical characteristics of solids -- Performulation -- Physical testing -- Development and validation of HPLC stability-indicationg 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 computerization of stability data -- Stability of polypeptides and proteins -- Regulatory aspects of stability testing in Europe -- Regulatory and scientific aspects of stability testing: present and possible future trends -- Appn.: Guidance for industry: stability testing of drug substances and drug products (draft).
650			_aDrug Stability
700			_aCarstensen, Jens Thur??,
700			_aRhodes, Christopher T.,
942			_bDIMC _cBK
999			_c27926 _d27926