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Volumn 31, Issue 4, 1997, Pages 1195-1201

Pharmaceutical validation and process controls in drug development

Author keywords

Assay validation; Process validation; Quality assurance; Release targets; United States pharmacopeia tests

Indexed keywords

DRUG;

EID: 0030720233     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100419     Document Type: Conference Paper
Times cited : (18)

References (13)
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    • Chow, S.C.1    Shao, J.2
  • 7
    • 0025816887 scopus 로고
    • On variance estimation in assay validation
    • Chow SC, Tse SK. On variance estimation in assay validation. Stat Med. 1991:10:1543-1553.
    • (1991) Stat Med. , vol.10 , pp. 1543-1553
    • Chow, S.C.1    Tse, S.K.2
  • 8
    • 84918595909 scopus 로고
    • A suggested validation
    • Chapman K. A suggested validation. Lexicon Pharm Tech. 1983;7:51-57.
    • (1983) Lexicon Pharm Tech. , vol.7 , pp. 51-57
    • Chapman, K.1
  • 9
    • 0025128297 scopus 로고
    • Constructing acceptance limits for multiple stage tests
    • Bergum JS. Constructing acceptance limits for multiple stage tests. Drug Develop Indul Pharma. 1990; 16:2153-2166.
    • (1990) Drug Develop Indul Pharma. , vol.16 , pp. 2153-2166
    • Bergum, J.S.1
  • 10
    • 0004094381 scopus 로고
    • Economic Control of Quality of Manufactured Product
    • Shewhart WA. Economic Control of Quality of Manufactured Product. New York: D. Van Nostrand; 1931.
    • (1931) New York: D. Van Nostrand
    • Shewhart, W.A.1
  • 11
    • 0342682968 scopus 로고
    • Acceptance control charts
    • Freund RA. Acceptance control charts. Ind Qual Com. 1957:14:13-23.
    • (1957) Ind Qual Com. , vol.14 , pp. 13-23
    • Freund, R.A.1
  • 12
    • 0002916530 scopus 로고
    • Continuous inspection schemes
    • Page ES. Continuous inspection schemes. Biometrika. 1954:41:100-115.
    • (1954) Biometrika. , vol.41 , pp. 100-115
    • Page, E.S.1
  • 13
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    • Constructing release targets for drug products: A decision theory approach
    • Shao J, Chow SC. Constructing release targets for drug products: a decision theory approach. J Roy StatSoc, C. 1991:40:381-390.
    • (1991) J Roy StatSoc, C. , vol.40 , pp. 381-390
    • Shao, J.1    Chow, S.C.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.