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Volumn 25, Issue 1, 2000, Pages 18-24

Dissolution and in vivo evidence of differences in reference products: Impact on development of generic drugs

Author keywords

Absorption; Bioequivalence; Dissolution; Generic; WHO

Indexed keywords

ALPRAZOLAM; CAPTOPRIL; CIMETIDINE; CONJUGATED ESTROGEN; EQUILIN; ESTRONE; GENERIC DRUG; INDAPAMIDE; LOZIDE; PHENYTOIN; PROPAFENONE; SOTALOL; VERAPAMIL;

EID: 0033810627     PISSN: 03787966     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03190051     Document Type: Review
Times cited : (9)

References (13)
  • 1
    • 0007890036 scopus 로고    scopus 로고
    • World Health Organization. Marketing Authorization of Pharmaceutical Products with Special Reference to Multi-Source (Generic) Products: A Manual for a Drug Regulatory Authority. Regulatory Support Series No. 5. Geneva: WHO
    • (1999)
  • 2
    • 85037929085 scopus 로고    scopus 로고
    • List of International Comparator Pharmaceutical Products (CPP) For Equivalence Assessment of Interchangeable Multi-Source (Generic) Products
    • Report of informal discussions on the selection of comparator pharmaceutical product for equivalent assessment of interchangeable multi-source (generic) products. Geneva: WHO
    • (1999) , pp. 8-17
  • 3
    • 85037947212 scopus 로고
    • The European Agency for the Evaluation of Medicinal Products/Human Medicines Evaluation Unit: Note for Guidance on The Investigation of Bioavailability and Bioequivalence. London
    • (1988)
  • 4
    • 0007890428 scopus 로고
    • Food and Drug Administration/Office of Generic Drugs/Division of Bioequivalence: Statistical Procedures for Bioequivalence Studies using a Standard Two-Treatment Crossover Design
    • (1992)
  • 5
    • 85037935923 scopus 로고    scopus 로고
    • Food and Drug Administration/Office of Generic Drugs/Division of Bioequivalence: Oral Extended (Controlled) Release Dosage Forms - In Vivo Bioequivalence and In Vitro Dissolution Testing
  • 6
    • 0007983686 scopus 로고
    • Drugs Directorate, Health Protection Branch: Conduct and Analysis of Bioavailability and Bioequivalence Studies. Part A: Oral Dosage Formulations used for Systemic Effects. Ottawa, Ontario, Canada
    • (1992)
  • 7
    • 0007886423 scopus 로고    scopus 로고
    • Therapeutic Products Programme Health Canada: Conduct and Analysis of Bioavailability and Bioequivalence Studies. Part B: Oral Modified Release Formulations. Ottawa, Ontario, Canada
    • (1996)
  • 9
    • 85037929807 scopus 로고
    • Director, Bureau of Drug Research, Health Canada. Personal communication
    • (1992)
    • McGilveray, I.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.