Dose spacing in early dose response clinical trial designs

Drug Information Journal

Volumn 36, Issue 4, 2002, Pages 855-864

  Hamlett, Anthony ^a   Ting, Naitee ^b   Choudary Hanumara, R ^c   Finman, Jeffrey S ^b  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^c 3D Group for Interactive Visualization   (United States)

Author keywords

Clinical trials; Dose response; Dose spacing; Early phase; Optimal design

Indexed keywords

NEW DRUG;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; DIAGNOSTIC APPROACH ROUTE; DISEASE MODEL; DOSE CALCULATION; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG RESEARCH; HUMAN; MATHEMATICAL COMPUTING; MAXIMUM TOLERATED DOSE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIMULATION;

EID: 0036978467     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150203600414     Document Type: Article

References (8)

1. Wong WK, Lachenbruch PA. Tutorial in biostatistics: Designing studies for dose response. Stat Med. 1996;15:343-359.
2. Ruberg SJ. Dose response studies I. Some design considerations. J Biopharmaceutical Stat. 1995;5(1):1-14.
3. Kiefer J. On the nonrandomized optimality and randomized nonoptimality of symmetric designs. Ann Math Stat. 1958;29:675-699.
4. Kiefer J. Optimum experimental Designs. J Royal Stat Society, Series B. 1959;21:273-319.
5. Silvey SD. Optimal Designs. London: Chapman and Hall Ltd; 1980.
6. Hedayat AS, Yan B, Pezzuto JM. Modeling and identifying optimum designs for fitting dose-response curves based on raw optical density data. J Am Stat Assoc. 1997;92(439):1132-1140.
7. Hamlett A. Dose selection study designs in early phase II clinical trials. Unpublished Ph.D. Dissertation, University of Rhode Island, 1999.
8. Sitter RR, Wu JCF. Two-stage design of quantal response studies. Biometrics. 1999;55(2):396-402.