The bioequivalence of highly variable drugs and drug products

International Journal of Clinical Pharmacology and Therapeutics

Volumn 43, Issue 10, 2005, Pages 485-498

  Midha, K K ^a,b   Rawson, M J ^a   Hubbard, J W ^a  

^a UNIVERSITY OF SASKATCHEWAN   (Canada)

^b UNIVERSITY OF SASKATCHEWAN   (Canada)

Author keywords

Arbitrarily broaden the bioequivalence acceptance limits; Average bioequivalence; Highly variable drug products; Highly variable drugs; Individual bioequivalence; Scaling the bioequivalence metrics; Systematic broadening of the bioequivalence acceptance limits; Two one sided test

Indexed keywords

7 HYDROXYCHLORPROMAZINE; CHLORPROMAZINE; CYCLOSPORIN; CYCLOSPORIN A; CYTOCHROME P450 2D6; DRUG; GLYCERYL TRINITRATE; NADOLOL; PRODRUG; PROPAFENONE; QUINIDINE ACID SULFATE;

ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; BIOEQUIVALENCE; CONFIDENCE INTERVAL; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG METABOLISM; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GEOMETRY; HUMAN; MATHEMATICAL COMPUTING; METABOLITE; REVIEW; STATISTICAL ANALYSIS; STEADY STATE; TABLET; VOLUNTEER;

EID: 26844547132     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP43485     Document Type: Review

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