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Volumn 48, Issue 3, 2008, Pages 1042-1045

Metrologic approaches to setting acceptance criteria: Unacceptable and unusual characteristics

Author keywords

Acceptance criteria; Drug quality; Metrology; Performance verification test; Standards

Indexed keywords

ARTICLE; DRUG DESIGN; DRUG QUALITY; GOOD MANUFACTURING PRACTICE; LABORATORY; MEASUREMENT; MEDICAL LITERATURE; PRIORITY JOURNAL; SAFETY; STANDARD;

EID: 53049083446     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2008.07.027     Document Type: Article
Times cited : (6)

References (9)
  • 2
    • 53049090075 scopus 로고    scopus 로고
    • FDA, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, 2002, accessed at www.fda.gov/cder/guidance/4964dft.pdf (accessed 29 August 2008).
    • FDA, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, 2002, accessed at www.fda.gov/cder/guidance/4964dft.pdf (accessed 29 August 2008).
  • 5
    • 53049084476 scopus 로고    scopus 로고
    • US Pharmacopeia, USP 31-NF 26, The Dissolution Procedure: Development and Validation, US Pharmacopeia, Rockville, MD, 2008.
    • US Pharmacopeia, USP 31-NF 26, The Dissolution Procedure: Development and Validation, US Pharmacopeia, Rockville, MD, 2008.
  • 7
    • 53049090691 scopus 로고    scopus 로고
    • ISO, Guide 43-01, Proficiency Testing by Interlaboratory Comparisons-Development and Operation of Proficience Testing Schemes, 2nd ed., ISO, Geneva, Switzerland, 1997.
    • ISO, Guide 43-01, Proficiency Testing by Interlaboratory Comparisons-Development and Operation of Proficience Testing Schemes, 2nd ed., ISO, Geneva, Switzerland, 1997.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.