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Volumn 25, Issue 1, 2000, Pages 13-17

The basis for individual bioequivalence

Author keywords

Average bioequivalence; Bioequivalence criterion; Individual bioequivalence; Non replicate; Replicate; Subject by formulation interaction

Indexed keywords

BIOEQUIVALENCE; DRUG FORMULATION; POPULATION; REPRODUCIBILITY; REVIEW; STANDARD; STATISTICAL ANALYSIS;

EID: 0033820341     PISSN: 03787966     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03190050     Document Type: Review
Times cited : (5)

References (10)
  • 2
    • 85037933061 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and research: Draft Guidance for Industry: Average, population and individual approaches to establishing bioequivalence
    • (1999)
  • 4
    • 85037938273 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation research: Draft Guidance for Industry: BA and BE studies for orally administered drug products - General consideration
    • (1999)
  • 5
    • 85037927715 scopus 로고    scopus 로고
    • Bioequivalence assessment: Irrationality within a rational science
    • Midha K., Nagai T. (eds) Bioavailability, Bioequivalence and Pharmacokinetic Studies, FIP BIO-International '96, Tokyo, Business Center for Academic Societies Japan
    • (1996) , pp. 29-32
    • Levy, G.1
  • 7
    • 85037936573 scopus 로고    scopus 로고
    • Average and individual BE criteria to compare BE measures - Replicate and non-replicate data sets. Advisory Committee for Pharmaceutical Science Meeting, September 23-24 1999, Rockville, MD, USA
    • (1999)
    • Williams, R.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.