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An approach to the assessment of therapeutic drug interactions with fixed combination drug products.

Publication ,  Journal Article
Rockhold, FW; Goldberg, MR
Published in: J Biopharm Stat
July 1996

Several complex clinical and statistical issues are involved in the development of a combination drug product. The medical rationale for the combination, the intended clinical use, drug-drug interactions, and dose response are just a few of the considerations. The factorial design is a useful experimental model for evaluating combination therapies. This paper outlines some of the considerations involved in the use of this design in the study of combination drugs. Questions related to design and methods of analysis are discussed in general and through use of an example. Such a design was applied to study the combination of a vasodilator with a diuretic in the treatment of hypertension. The sample size derivation, the evaluation of "interaction," the use of ANOVA versus regression techniques, and methods of data display are reviewed. It is recognized that although these are complex issues, substantially more information per patient can be obtained than with standard parallel-design approaches. The design could be an especially powerful tool early in the development of a drug.

Duke Scholars

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

July 1996

Volume

6

Issue

3

Start / End Page

231 / 240

Location

England

Related Subject Headings

  • Statistics & Probability
  • Prodrugs
  • Humans
  • Evaluation Studies as Topic
  • Drug Therapy
  • Drug Interactions
  • Drug Combinations
  • Data Interpretation, Statistical
  • Clinical Trials as Topic
  • 4905 Statistics
 

Citation

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Rockhold, F. W., & Goldberg, M. R. (1996). An approach to the assessment of therapeutic drug interactions with fixed combination drug products. J Biopharm Stat, 6(3), 231–240. https://doi.org/10.1080/10543409608835139
Rockhold, F. W., and M. R. Goldberg. “An approach to the assessment of therapeutic drug interactions with fixed combination drug products.J Biopharm Stat 6, no. 3 (July 1996): 231–40. https://doi.org/10.1080/10543409608835139.
Rockhold FW, Goldberg MR. An approach to the assessment of therapeutic drug interactions with fixed combination drug products. J Biopharm Stat. 1996 Jul;6(3):231–40.
Rockhold, F. W., and M. R. Goldberg. “An approach to the assessment of therapeutic drug interactions with fixed combination drug products.J Biopharm Stat, vol. 6, no. 3, July 1996, pp. 231–40. Pubmed, doi:10.1080/10543409608835139.
Rockhold FW, Goldberg MR. An approach to the assessment of therapeutic drug interactions with fixed combination drug products. J Biopharm Stat. 1996 Jul;6(3):231–240.
Journal cover image

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

July 1996

Volume

6

Issue

3

Start / End Page

231 / 240

Location

England

Related Subject Headings

  • Statistics & Probability
  • Prodrugs
  • Humans
  • Evaluation Studies as Topic
  • Drug Therapy
  • Drug Interactions
  • Drug Combinations
  • Data Interpretation, Statistical
  • Clinical Trials as Topic
  • 4905 Statistics