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Volumn 38, Issue 5, 1998, Pages 401-404

Acceptable and unacceptable procedures in bioavailability and bioequivalence trials

Author keywords

Bioavailability; Bioequivalence; Operating guidelines; Pharmacokinetic parameters; Statistical analysis

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; COMPARTMENT MODEL; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DEVELOPMENT; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; PHARMACOKINETICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; STATISTICAL ANALYSIS; UNITED STATES;

EID: 0032212920     PISSN: 10436618     EISSN: None     Source Type: Journal    
DOI: 10.1006/phrs.1998.0380     Document Type: Article
Times cited : (10)

References (17)
  • 1
    • 0001668733 scopus 로고
    • Bioavailability and bioequivalence requirements
    • 1. US Food and Drug Administration. Bioavailability and bioequivalence requirements. Fed. Register 1977; 42: 1638-53.
    • (1977) Fed. Register , vol.42 , pp. 1638-1653
  • 2
    • 79551604485 scopus 로고    scopus 로고
    • National formulary Supplement N° 5
    • 2. US Pharmacopeia 23. National formulary Supplement N° 5. In vivo bioequivalence guidances, 1996: 3490-531.
    • (1996) In Vivo Bioequivalence Guidances , pp. 3490-3531
  • 3
    • 0010320412 scopus 로고
    • EU Note for guidance: Investigation of bioavailability and bioequivalence
    • Addendum 2
    • 3. EU Note for guidance: Investigation of bioavailability and bioequivalence. The Regulatory Affairs Journal III, Addendum 2, 1992.
    • (1992) The Regulatory Affairs Journal , vol.3
  • 4
    • 0029151246 scopus 로고
    • The bioequivalence: An updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products
    • 4. Marzo A, Balant LP. The bioequivalence: an updated reappraisal addressed to applications of interchangeable multi-source pharmaceutical products. Arzneim Forsch 1995; 45: 109-15
    • (1995) Arzneim Forsch , vol.45 , pp. 109-115
    • Marzo, A.1    Balant, L.P.2
  • 5
    • 0002571093 scopus 로고
    • Farmacocinetica e metabolismo dei farmaci
    • Manuale di chemioterapia. Fraschini F, Nicolin A. eds.
    • 5. Marzo A, Scaglione F. Farmacocinetica e metabolismo dei farmaci. In: Manuale di chemioterapia. Fraschini F, Nicolin A. eds. Casa Editrice Ambrosiana, 3rd edition, 1995: 83-96.
    • (1995) Casa Editrice Ambrosiana, 3rd Edition , pp. 83-96
    • Marzo, A.1    Scaglione, F.2
  • 6
    • 0032015128 scopus 로고    scopus 로고
    • Quale modello nell'analisi farmacocinetica di studi di biodisponibilità e bioequivalenza?
    • 6. Marzo A, Ceppi Monti N. Quale modello nell'analisi farmacocinetica di studi di biodisponibilità e bioequivalenza? Boll Chim Farm 1998; 137: 69-73.
    • (1998) Boll Chim Farm , vol.137 , pp. 69-73
    • Marzo, A.1    Ceppi Monti, N.2
  • 7
    • 0031302204 scopus 로고    scopus 로고
    • Pharmacokinetic analysis, bioavailability and operating guidelines
    • 7. Marzo A. Pharmacokinetic analysis, bioavailability and operating guidelines. J Pharm Pharmacol 1997; 49: 1259-60.
    • (1997) J Pharm Pharmacol , vol.49 , pp. 1259-1260
    • Marzo, A.1
  • 8
    • 0028084863 scopus 로고
    • Pharmacokinetics of oxicam nonsteroidal anti-inflammatory agents
    • 8. Olkkola KT, Brunetto AV, Mattila MJ. Pharmacokinetics of oxicam nonsteroidal anti-inflammatory agents. Clin Pharmacokinet 1994; 26: 107-20.
    • (1994) Clin Pharmacokinet , vol.26 , pp. 107-120
    • Olkkola, K.T.1    Brunetto, A.V.2    Mattila, M.J.3
  • 10
    • 0031446080 scopus 로고    scopus 로고
    • Clinical pharmacokinetic registration file for NDA and ANDA procedures
    • 10. Marzo A. Clinical pharmacokinetic registration file for NDA and ANDA procedures. Pharmacol Res 1997; 36: 425-50.
    • (1997) Pharmacol Res , vol.36 , pp. 425-450
    • Marzo, A.1
  • 11
    • 0027157983 scopus 로고
    • Pharmacokinetics of endogenous substances: Some problems and some solutions
    • 11. Marzo A, Rescigno A. Pharmacokinetics of endogenous substances: some problems and some solutions. Eur J Drug Metab Pharmacokinet 1993; 18: 77-88.
    • (1993) Eur J Drug Metab Pharmacokinet , vol.18 , pp. 77-88
    • Marzo, A.1    Rescigno, A.2
  • 12
    • 0026764201 scopus 로고
    • Enzymes in stereoselective pharmacokinetics of endogenous substances
    • 12. Marzo A, Cardace G, Arrigoni Martelli E. Enzymes in stereoselective pharmacokinetics of endogenous substances. Chirality 1992; 4: 247-51.
    • (1992) Chirality , vol.4 , pp. 247-251
    • Marzo, A.1    Cardace, G.2    Arrigoni Martelli, E.3
  • 13
    • 0031582897 scopus 로고    scopus 로고
    • L-carnitine moiety assay: An up-to-date reappraisal covering the commonest methods for various applications
    • 13. Marzo A, Curti S. L-carnitine moiety assay: an up-to-date reappraisal covering the commonest methods for various applications. J Chromatogr B 1997; 702: 1-20.
    • (1997) J Chromatogr B , vol.702 , pp. 1-20
    • Marzo, A.1    Curti, S.2
  • 14
    • 0017028729 scopus 로고
    • Symmetrical confidence intervals for bioequivalence trials
    • 14. Westlake W.J. Symmetrical confidence intervals for bioequivalence trials. Biometrics 1976; 32: 741-4.
    • (1976) Biometrics , vol.32 , pp. 741-744
    • Westlake, W.J.1
  • 15
    • 0027490777 scopus 로고
    • International harmonisation of regulatory bioequivalence requirements
    • 15. Steinijans VW, Hauschke D. International harmonisation of regulatory bioequivalence requirements. Clin Res Reg Affairs 1993; 10: 203-20.
    • (1993) Clin Res Reg Affairs , vol.10 , pp. 203-220
    • Steinijans, V.W.1    Hauschke, D.2
  • 16
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedures and the power approach for assessing the equivalence of average bioavailability
    • 16. Schuirmann DJ. A comparison of the two one-sided tests procedures and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987; 15: 657-80.
    • (1987) J Pharmacokinet Biopharm , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 17
    • 0029597893 scopus 로고
    • Open questions in bioequivalence
    • 17. Marzo A. Open questions in bioequivalence. Pharmacol Res 1995; 32: 237-40.
    • (1995) Pharmacol Res , vol.32 , pp. 237-240
    • Marzo, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.