PMID: 9160497May 15, 1997Paper

Statistical methods for two-sequence three-period cross-over designs with incomplete data

Statistics in Medicine
S C Chow, J Shao

Abstract

In clinical trials, and in bioavailability and bioequivalence studies, one often encounters replicate cross-over designs such as a two-sequence three-period cross-over design to assess treatment and carry-over effects of two formulations of a drug product. Because of the potential dropout (or for some administrative reason), however, the observed data set from a replicate cross-over design is incomplete or unbalanced so that standard statistical methods for a cross-over design may not apply directly. For inference on the treatment and carry-over effects, we propose a method based on differences of the observations that eliminates the random subject effects and thus does not require any distributional condition on the random subject effects. When no datum is missing, this method provides the same results as the ordinary least squares method. When there are missing data, the proposed method still provides exact confidence intervals for the treatment and carry-over effects, as long as the dropout is independent of the measurement errors. We provide an example for illustration.

Citations

Apr 22, 2011·Planta medica·Jonathan ShusterSaunjoo Yoon
Sep 15, 2015·Journal of Biopharmaceutical Statistics·Shein-Chung ChowMeng Chen
Jan 3, 2006·Biometrical Journal. Biometrische Zeitschrift·Nam-Kyoo LimEd Stanek
Dec 10, 2016·Journal of Biopharmaceutical Statistics·Meng Chen, Shein-Chung Chow
Feb 7, 2014·Statistical Methods in Medical Research·Gerd K Rosenkranz
Aug 5, 2005·Journal of Biopharmaceutical Statistics·Jae-Young LeeSang-Gue Park
Apr 6, 2006·Journal of Biopharmaceutical Statistics·Guohua Pan, Yibin Wang
Jun 27, 2003·Journal of Clinical Psychopharmacology·Francois Curtin

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.