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Volumn 40, Issue 6, 2000, Pages 561-570

PhRMA perspective on population and individual bioequivalence

Author keywords

[No Author keywords available]

Indexed keywords

BIOEQUIVALENCE; DRUG INDUSTRY; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HISTORY OF MEDICINE; INDIVIDUALIZATION; MATHEMATICAL ANALYSIS; METHODOLOGY; POPULATION RESEARCH; PRACTICE GUIDELINE; REVIEW;

EID: 0033667817     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.2000.tb05980.x     Document Type: Review
Times cited : (45)

References (29)
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    • 0006886815 scopus 로고    scopus 로고
    • Food and Drug Administration: Guidance for Industry: In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Approaches. Food and Drug Administration
    • (1997)
  • 6
    • 0006966090 scopus 로고
    • Bioavailability and bioequivalence: Definitions and difficulties in acceptance criteria
    • Midha KK, Blume H (eds.), Bio-International Bioavailability: Bioequivalence and Pharmacokinetics. Stuttgart: Medpharm
    • (1993) , pp. 27-35
    • Benet, L.Z.1
  • 10
  • 11
    • 17444453579 scopus 로고    scopus 로고
    • Workshop report: Evaluation of orally administered highly variable drugs and drug formulations
    • (1996) Pharmaceutical Research , vol.13 , pp. 1590-1594
    • Shah, V.P.1
  • 12
    • 85037803743 scopus 로고    scopus 로고
    • AAPS Workshop on Scientific and Regulatory Issues in Product Quality: Narrow therapeutic index drugs and individual bioequivalence. Paper presented March 16-18, Arlington, VA
    • (1998)
  • 13
    • 0025810003 scopus 로고
    • Sensitivity analysis of the effect of bioavailability or dosage form content on mean steady-state phenytoin concentrations
    • (1991) Therapeutic Drug Monitoring , vol.13 , pp. 120-125
    • Ludden, T.M.1
  • 16
    • 0029083127 scopus 로고
    • Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar
    • (1995) Biometrics , vol.51 , pp. 615-626
    • Schall, R.1
  • 29
    • 0017146303 scopus 로고
    • On closed testing procedures with special reference to ordered analysis of variance
    • (1976) Biometrika , vol.63 , pp. 655-660
    • Marcus, R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.