Study design, methodology and statistical analyses in the clinical development of sparfloxacin

Journal of Antimicrobial Chemotherapy

Volumn 37, Issue SUPPL. A, 1996, Pages 65-72

  Genevois, E ^a   Lelouer, V ^b   Vercken, Jean Baptiste ^b   Caillon, R ^b  

^a SANOFI   (France)

^b Rhône D P C Europe ^*  (France)

Author keywords

[No Author keywords available]

Indexed keywords

QUINOLINE DERIVED ANTIINFECTIVE AGENT; SPARFLOXACIN;

ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; HUMAN; ORAL DRUG ADMINISTRATION; PATIENT CODING; PNEUMONIA; RESPIRATORY TRACT INFECTION;

ANTI-INFECTIVE AGENTS; DOUBLE-BLIND METHOD; FLUOROQUINOLONES; HUMANS; INTERNATIONAL COOPERATION; MULTICENTER STUDIES; QUINOLONES; RANDOMIZED CONTROLLED TRIALS; STATISTICS;

EID: 0029953035     PISSN: 03057453     EISSN: None     Source Type: Journal    
DOI: 10.1093/jac/37.1.65     Document Type: Article

References (8)

1. Anthonisen, N. R., Manfreda, J., Warren, C. P. W., Hershfield, E. S., Harding, G. K. M. & Nelson, N. A. (1987). Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Annals of Internal Medicine 106, 196-204.
2. Beam, T. R., Gilbert D. N. & Kunin C. M. (1992). General guidelines for the clinical evaluation of anti-infective drug products. Clinical Infectious Disease 15, Suppl. 1.
3. Beam, T. R., Gilbert D. N. & Kunin C. M. (1993). European guidelines for the clinical evaluation of anti-infective drug products. Clinical Infectious Diseases 17, 787-8.
4. Chow, J. W. & Yu V. L. (1989). Antibiotic studies in pneumonia. Pitfalls in interpretation and suggested solutions. Chest 96, 453-456.
5. FDA (1977). Guidelines for the clinical evaluation of anti-infective (systemic) drugs (adults and children). Publication no. FDA-77-3046. US Department of Health, Education and Welfare, Washington, DC.
6. Makuch, R. & Simon, R. (1978). Sample size requirements for evaluating a conservative therapy. Cancer Treatment Reports 62, 1037-40.
7. Pocock, S. J., Hughes, M. D. & Lee, R. J. (1987). Statistical problems in the reporting of clinical trials. New England Journal of Medicine 317, 426-32.
8. Vercken, J. B. (1991). Essais thérapeutiques randomisés des pneumopathies communautaires. Revue de Pneumologie Clinique 47, 21-7.