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Volumn 15, Issue 4, 1995, Pages 433-440

Bioequivalence and Narrow Therapeutic Index Drugs

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG;

EID: 0029026110     PISSN: 02770008     EISSN: 18759114     Source Type: Journal    
DOI: 10.1002/j.1875-9114.1995.tb04379.x     Document Type: Article
Times cited : (92)

References (18)
  • 1
    • 85024822150 scopus 로고
    • 1989: Hearings Before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, 101st Cong., 1st Sess.
    • (1989)
  • 2
    • 85024806213 scopus 로고
    • Management Advisory Report: Vulnerabilities in the Food and Drug Administration's Generic Drug Approval Process. A‐15‐89‐00051; August 17, 1989; Perspectives of Drug Manufacturers, Abbreviated New Drug Appli‐cations. OEI‐12‐90‐00770; February 1990; Perspectives of Drug Manufacturers, Investigational New Drug and New Drug Applications. OEI‐12‐90‐00771; February 1990; Review of the Food and Drug Administration's Generic Drug Management Information System. A‐15‐89‐00063;, Washington, D.C.
    • (1990)
  • 3
    • 85024777935 scopus 로고
    • In: Proceedings of the international open conference on dissolution, bioavailability and bioequivalence. Rockville, MD:, U.S. Pharmacopeial Convention
    • (1992) Narrow therapeutic index drugs , pp. 35-39
    • Benet, LZ1
  • 7
    • 85024775784 scopus 로고
    • Biopharmaceutics: old issues and new controversies. Presented at the 31st international industrial pharmacy conference, Austin, TX, 2427
    • (1992)
    • Peck, CC1
  • 11
    • 0019492559 scopus 로고
    • Statistical simulation study of new proposed uniformity requirement for bioequivalency studies
    • (1981) J Pharm Sci , vol.70 , pp. 673-675
    • Haynes, JD1
  • 12
    • 0021271539 scopus 로고
    • A new statistical procedure for testing equivalence in two‐group comparative bioavailability trials
    • (1984) J Pharm Sci , vol.12 , pp. 83-91
    • Hauck, WW1    Anderson, SJ2
  • 13
    • 0017028729 scopus 로고
    • Symmetric confidence intervals for bioequivalence trials
    • (1976) Biometrics , vol.32 , pp. 741-744
    • Westlake, WJ1
  • 14
    • 0023615056 scopus 로고
    • A comparison of the two one‐sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • (1987) J Pharmacokinet Biopharm , vol.15 , pp. 657-680
    • Schuirmann, DJ1
  • 18
    • 85024818353 scopus 로고    scopus 로고
    • Title 21, Part 320.25(a)(1).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.