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Yakugaku Zasshi
Volumn 120, Issue 11, 2000, Pages 1193-1200
International harmonization of bioequivalence studies and issues shared in common
Author keywords

Bioavailability; Bioequivalence; Generic product; Guideline; Innovator product; International harmonization
Indexed keywords

GENERIC DRUG;
EID: 0033662758     PISSN: 00316903     EISSN: None     Source Type: Journal    
DOI: 10.1248/yakushi1947.120.11_1193     Document Type: Article
Times cited : (20)
References (22)
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    • Food and Drug Administration: Statistical procedures for bioequivalence studies using a standard two-treatment crossover design (guidance), Jul., 1992
    • (1992)
  • 11
    • 0006879651 scopus 로고    scopus 로고
    • Food and Drug Administration: Food-Effect Bioavailability and Bioequivalence Studies (Draft Guidance), Oct., 1997
    • (1997)
  • 12
    • 0006975946 scopus 로고
    • Food and Drug Administration: Guidance for industry immediate release solid oral dosage forms scale-up and postapproval changes: chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation
    • (1995)
  • 13
    • 85037796416 scopus 로고
    • Concerning the examination of variations to the terms of a marketing authorization granted by a competent authority of a Member State, Commission Regulation (EC) No 541/95, Mar., 1995
    • (1995)
  • 14
    • 85037786064 scopus 로고
    • Concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93, Commission Regulation (EC) No 542/95, Mar., 1995
    • (1995)
  • 15
    • 85037798217 scopus 로고    scopus 로고
    • Ministry of Health and Welfare: Guideline for bioequivalence studies of oral preparations of different contents, 64, Feb., 2000
    • (2000)
  • 16
    • 85037785548 scopus 로고    scopus 로고
    • Ministry of Health and Welfare: Guideliwe for bioequivalence studies to modify oral preparations, 67, Feb., 2000
    • (2000)
  • 21
    • 0006881413 scopus 로고    scopus 로고
    • Food and Drug Administration: In vivo bioequivalence studies based on population and individual bioequivalence approaches (DRAFT GUIDANCE), Oct., 1997
    • (1997)
  • 22
    • 0006924966 scopus 로고    scopus 로고
    • Food and Drug Administration: Average, population, and individual approaches to establishing bioequivalence (DRAFT GUIDANCE), Aug., 1999
    • (1999)

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.