Choice of delta: A special case

Drug Information Journal

Volumn 35, Issue 3, 2001, Pages 875-879

  Hauschke, D ^a  

^a ALTANA PHARMA AG   (Germany)

Author keywords

Equivalence; Noninferiority; Ratio of Means

Indexed keywords

PLACEBO;

BIOEQUIVALENCE; CONFERENCE PAPER; DRUG BIOAVAILABILITY; DRUG RESEARCH; METHODOLOGY; PRIORITY JOURNAL; STATISTICAL ANALYSIS; STATISTICAL MODEL;

EID: 0034847372     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150103500326     Document Type: Conference Paper

References (13)

1. ICH harmonized tripartite guideline. Statistical principles for clinical trials
2. Statistical significance
3. Unconditional non-asymptotic one-sided tests for independent binomial proportions when the interest lies in showing non-inferiority and/or superiority
4. Some issues in the design and analysis of equivalence trials
5. Establishing equivalence by showing that a specified percentage of the effect of the active control over placebo is maintained
6. Sample size determination for proving equivalence based on the ratio for normally distributed data
7. Approximate sample sizes for testing hypotheses about the ratio and difference of two means
8. Morikawa T Design issues in non-inferiority/equivalence trials
9. Recommendations concerning studies on therapeutic equivalence
10. Clinical equivalence - A clarification
11. Therapeutic equivalence investigations: Statistical considerations