000 02414cam a22003854i 4500
999 _c2106
_d2106
001 11988339
005 20210307115038.0
008 000427s2000 nyua b 001 0 eng
010 _a 00031584
020 _a0824703766 (alk. paper)
040 _aDLC
_cDLC
_dDLC
_erda
042 _apcc
050 0 0 _aRS424
_b.C37 2000
082 0 0 _a615.1901
_221
_bD
245 0 0 _aDrug stability :
_bprinciples and practices /
_cedited by Jens T. Carstensen, C.T. Rhodes.
250 _aThird edition, revised and expanded.
264 1 _aNew York :
_bMarcel Dekker,
_c[2000].
264 4 _c©2000.
300 _avii, 773 pages. :
_bIllustrations ;
_c26 cm
336 _2rdacontent
_atext
337 _2rdamedia
_aunmediated
338 _2rdacarrier
_avolume
490 0 _aDrugs and the pharmaceutical sciences ;
_vv. 107.
500 _aPrevious editions cataloged under: Cartensen, Jens Thurø, 1926- Drug stability.
504 _aIncludes bibliographical references and indexes.
505 0 _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-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 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 0 _aDrug stability.
700 1 _aRhodes, Christopher T.,
_d1937-,
_eeditor.
700 1 _aCarstensen, Jens Thurø,
_d1926-,
_eeditor.
700 1 _aCarstensen, Jens Thurø,
_d1926-
_tDrug stability.
_98599
856 4 2 _3Publisher description
_uhttp://www.loc.gov/catdir/enhancements/fy0647/00031584-d.html
906 _a7
_bcbc
_corignew
_d1
_eocip
_f20
_gy-gencatlg
942 _2ddc
_cBK