Statistical considerations of FDA and CPMP rules for the investigation of new anti-bacterial products

Statistics in Medicine

Volumn 20, Issue 17-18, 2001, Pages 2561-2571

  Rhmel, Joachim ^a,b  

^a Drugs and Medical Devices   (Germany)

^b Federal Institute   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; NEW DRUG;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG APPROVAL; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; EUROPE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HEALTH CARE PLANNING; HEALTH CARE QUALITY; HUMAN; MEDICAL PRACTICE; PRACTICE GUIDELINE; QUALITY CONTROL; STATISTICAL ANALYSIS; STATISTICAL CONCEPTS;

ANTI-INFECTIVE AGENTS; CONFIDENCE INTERVALS; CONTROLLED CLINICAL TRIALS; EUROPE; HUMANS; SAMPLE SIZE; STATISTICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035884664     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.729     Document Type: Article

References (18)

1. Test statistics and sample size formulae for comparative binomial trials with the null hypothesis of non-zero difference or non-unit relative risk
2. Confidence bounds for the difference between two probabilities
3. Interval estimation for the difference between independent proportions: A comparison of eleven methods
4. Significance testing to establish equivalence between treatments, with special reference to data in the form of 2 × 2 tables
5. 2 in 2 × 2 contingency tables
6. Likelihood weighted confidence intervals for the difference of two binomial proportions
7. Unconditional, non-asymptotic one-sided tests for independent binomial proportions when the interest lies in showing non-inferiority and/or superiority
8. Test based exact confidence intervals for the difference of two binomial proportions
9. A new test for 2 × 2 tables
10. P values maximized over a confidence set for the nuisance parameter
11. Exact unconditional sample size for the 2 × 2 binomial trial
12. Raised conditional level of significance for the 2 × 2 table when testing the equality of two probabilities
13. Exact tests of equivalence and efficacy with non-zero lower bound for comparative studies
14. Letter to the Editor on 'Exact tests of equivalence and efficacy with a non-zero lower bound for comparative studies' by I Chan