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WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-ninth report

WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-ninth report

자료유형
단행본
단체저자명
WHO Expert Committee on Specifications for Pharmaceutical Preparations.
서명 / 저자사항
WHO Expert Committee on Specifications for Pharmaceutical Preparations : forty-ninth report / WHO Expert Committee on Specifications for Pharmaceutical Preparations.
발행사항
Geneva, Switzerland :   World Health Organization,   c2015.  
형태사항
xi, 210 p. : ill. ; 24 cm.
총서사항
WHO technical report series,0512-3054 ; 992
기타표제
Forty-ninth report of the WHO Expert Committee on specifications for pharmaceutical preparations
ISBN
9789241209922
서지주기
Includes bibliographical references.
일반주제명
Pharmaceutical Preparations --standards --Congresses. Technology, Pharmaceutical --standards --Congresses. Drug Industry --legislation & jurisprudence --Congresses. Drugs --Standards --Congresses. Drugs --Specifications --Congresses. Drugs --Quality control --Congresses.
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246 3 0 ▼a Specifications for Pharmaceutical Preparations
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650 0 ▼a Drugs ▼x Standards ▼v Congresses.
650 0 ▼a Drugs ▼x Specifications ▼v Congresses.
650 0 ▼a Drugs ▼x Quality control ▼v Congresses.
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소장정보

No. 소장처 청구기호 등록번호 도서상태 반납예정일 예약 서비스
No. 1 소장처 학술정보관(CDL)/B1 국제기구자료실(UN)/UN-W 청구기호 610.8 t 992 등록번호 181009928 도서상태 대출불가(자료실) 반납예정일 예약 서비스 M

컨텐츠정보

책소개

In the area of quality control, the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia, and received the annual report of the European Directorate for the Quality of Medicines and HealthCare, the custodian center for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs, general texts and ICRS.

It noted the report on Phase 5 of the External Quality Assurance Assessment Scheme and on new approaches to ensure sustainability of this scheme through user fees. The Committee further received a concept paper on the benefits of good pharmacopoeial practices (GPhP), and was informed of progress achieved with developing a comprehensive document on GPhP. It adopted eight guidelines and 16 technical supplements, including a new guidance text on good review practice prepared under the leadership of the Asian-Pacific Economic Cooperation Regulatory Harmonization Steering Committee. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project.


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저자소개

World Health Organization(지은이)

<WHO 음용수 수질 가이드라인>

정보제공 : Aladin

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