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Volumn 44, Issue 5, 2007, Pages 1064-1071

Validation of a dissolution method with HPLC analysis for lasofoxifene tartrate low dose tablets

Author keywords

Dissolution; HPLC; Intermediate precision; Low dose tablet; Method robustness; Statistical design; Validation

Indexed keywords

LASOFOXIFENE;

EID: 34547749328     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2007.04.032     Document Type: Article
Times cited : (19)

References (14)
  • 1
    • 34547797769 scopus 로고    scopus 로고
    • ICH-Q2A Guideline for Industry, Text on Validation of Analytical Procedures, March 1995.
  • 2
    • 34547771964 scopus 로고    scopus 로고
    • Guidance for Industry, Q2B Validation of Analytical Procedures: Methodology, November 1996.
  • 13
    • 34547770128 scopus 로고    scopus 로고
    • Drug Approval and Licensing Procedures in Japan, Yakugyo Jiho Co., Ltd., 1998.
  • 14
    • 34547765717 scopus 로고    scopus 로고
    • Dissolution Testing of Immediate Release Solid Oral Dosage Forms, US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Guidance for Industry, August 1997.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.