Biopharmaceutical statistics in a pharmaceutical regulated environment: Past, present, and future

Journal of Biopharmaceutical Statistics

Volumn 11, Issue 4, 2001, Pages 347-372

  Segreti, Anthony C ^a   Leung, Hoi M ^b   Koch, Gary G ^c   Davis, Robert L ^d   Mohberg, Noel R ^e   Peace, Karl E ^f  

^a GLAXOSMITHKLINE   (United States)

^b IQVIA   (United States)

^c University of North Carolina at Chapel Hill   (United States)

^d ASTRAZENECA   (United Kingdom)

^e Biopharmaceutical Research Consultants Inc   (United States)

^f NONE

Author keywords

FDA; Pharmaceutical industry; Regulation

Indexed keywords

BIOMETRY; COVARIANCE; DATA ANALYSIS; DRUG INDUSTRY; EVOLUTION; FOOD AND DRUG ADMINISTRATION; FUTUROLOGY; METHODOLOGY; PRESCRIPTION; PRIORITY JOURNAL; REVIEW; STATISTICS; TRAINING;

BIOPHARMACEUTICS; CLINICAL TRIALS; DRUG APPROVAL; DRUG INDUSTRY; FORECASTING; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035560832     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120006096     Document Type: Review

References (23)

1. Outline of the history of U.S. drug regulation and labeling
2. Investigations and reports respecting FDA regulation of new drugs (Part I)
3. Investigations and reports respecting FDA regulation of new drugs (Part II)
4. New approaches to the analysis of clinical trial data with withdrawals
5. Some problems in interval estimation
6. Symmetric confidence intervals for bioequivalence trials
7. Interim analysis in the Pharmaceutical Industry
8. A multiple testing procedure for clinical trials
9. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial
10. Minimization: A new method of assigning patients to treatment and control groups
11. Issues involved in a meta-analysis of rheumatoid arthritis radiographic progression: Analysis issues
12. A multiple comparison procedure for comparing several treatments with a control
13. A sharper Bonferroni procedure for multiple tests of significance
14. A simple sequentially rejective multiple test procedure
15. An improved Bonferroni procedure for multiple tests of significance
16. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials
17. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis
18. International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use E3: Structure and content of clinical study reports
19. International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use E9: Statistical principles for clinical trials
20. An assessment of the safety of pediatric ibuprofen: A practictioner based randomized clinical trial