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007 cr cn|||||||||
008 060721s2006 sz a sb i100 0 eng d
020 _z9241209372
035 _a(CaPaEBR)ebr10137826
035 _a(OCoLC)70830413
040 _aCaPaEBR
_cCaPaEBR
050 1 4 _aRA8
_b.A247 2006eb
245 0 0 _aWHO Expert Committee on Specifications for Pharmaceutical Preparations
_h[electronic resource] :
_bfortieth report.
260 _aGeneva :
_bWorld Health Organization,
_c2006.
300 _ax, 461 p. :
_bill.
490 1 _aWHO technical report series ;
_v937
500 _a"WHO Expert Committee on Specifications for Pharmaceutical Preparations, Geneva, 24-28 October 2005"--P. vii.
504 _aIncludes bibliographical references.
520 _aThis report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Annexes include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.
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(40th :
_d2005 :
_cGeneva, Switzerland)
710 2 _aebrary, Inc.
830 0 _aTechnical report series (World Health Organization) ;
_v937.
856 4 0 _uhttp://site.ebrary.com/lib/daystar/Doc?id=10137826
_zAn electronic book accessible through the World Wide Web; click to view
908 _a170314
942 0 0 _cEB
999 _c74916
_d74916