Equivalence concepts in clinical trials

European Journal of Drug Metabolism and Pharmacokinetics

Volumn 25, Issue 1, 2000, Pages 38-40

  Steinijans, V W ^a   Neuhauser, M ^a   Bretz, F ^a  

^a ALTANA PHARMA AG   (Germany)

Author keywords

Clinical trials; Equivalence; Non inferiority; Statistics

Indexed keywords

NEW DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CLINICAL TRIAL; DOSE RESPONSE; DRUG FORMULATION; ETHICS; HUMAN; PRACTICE GUIDELINE; REVIEW; STATISTICAL ANALYSIS;

EID: 0033815483     PISSN: 03787966     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03190056     Document Type: Review

References (13)

1. Statistical principles for clinical trials, ICH E9 harmonised tripartite guideline
2. A useful testing strategy in phase III trials: Combined test of superiority and test of equivalence
3. Clinical and statistical issues in therapeutic equivalence trials
4. The evaluation of multiple clinical endpoints, with application to asthma
5. Asthma management: The challenge of equivalence
6. Practical issues in equivalence trials
7. Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol provides equivalent asthma control to chlorofluorocarbon beclomethasone dipropionate at approximately half the total daffy dose
8. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data
9. Points to consider on biostatistical/methodological issues arising from recent CPMP discussions on licensing application: Superiority, non-inferiority and equivalence (draft)
10. A confirmatory strategy for therapeutic equivalence trials
11. Therapeutic equivalence investigations: Statistical considerations
12. On clinically relevant differences and shifted null hypotheses