000 02414nam a2200349Ia 4500
001 ebr10120282
003 CaPaEBR
007 cr cn|||||||||
008 051214s2005 sz a sb i100 0 eng d
020 _z9241209291
040 _aCaPaEBR
_cCaPaEBR
035 _a(OCoLC)647484173
050 1 4 _aRA8
_b.A247 2005eb
245 0 0 _aWHO Expert Committee on Specifications for Pharmaceutical Preparations
_h[electronic resource] :
_bthirty-ninth report.
260 _aGeneva :
_bWorld Health Organization,
_c2005.
300 _avii, 142 p. :
_bill.
490 1 _aWHO technical report series ;
_v929
500 _a"WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 25-29 October 2004"--P. v.
504 _aIncludes bibliographical references.
520 _aThis report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices, inspection, distribution and trade, and other aspects of quality assurance of pharmaceuticals, and regulatory issues. Several annexes include an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products, and draft guidelines for registration of fixed-dose combination medicinal products.
533 _aElectronic reproduction.
_bPalo Alto, Calif. :
_cebrary,
_d2009.
_nAvailable via World Wide Web.
_nAccess may be limited to ebrary affiliated libraries.
650 0 _aDrugs
_xStandards
_vCongresses.
650 0 _aPharmacopoeias
_vCongresses.
650 0 _aDrugs
_xQuality control
_vCongresses.
655 7 _aElectronic books.
_2local
710 2 _aWorld Health Organization.
710 2 _aWHO Expert Committee on Specifications for Pharmaceutical Preparations
_n(39th :
_d2004 :
_cGeneva, Switzerland)
710 2 _aebrary, Inc.
830 0 _aTechnical report series (World Health Organization) ;
_v929.
856 4 0 _uhttp://site.ebrary.com/lib/kliuc/Doc?id=10120282
_zAn electronic book accessible through the World Wide Web; click to view
999 _c48734
_d48734