 Design and Analysis of Clinical Pharmacology StudiesWinnie Weng () and
Liang Fang
A chapter in Statistical Methods in Biomarker and Early Clinical Development, 2019, pp 197-220 from Springer Abstract: Abstract Clinical pharmacology studies are collections of clinical trials designed to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a new drug entity. These studies characterize the absorption, distribution, metabolism, and elimination of a drug in human body, and provide critical information for drug labeling. In this chapter, we will introduce different types of clinical pharmacology studies, their PK and safety endpoints, and essential design elements associated with each type of the studies. We will discuss statistical considerations for new study planning, including comparison between various types of designs, as well as power and sample size calculation. We will also discuss commonly used statistical analysis methods, including bioequivalence testing, dose proportionality evaluation, assessment of time-to-steady-state, nonparametric testing of additional PK parameters, and analysis of other safety endpoints. Regulatory guidelines and recommended practice will be reviewed as well. Date: 2019 There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it. Related works: Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-030-31503-0_10 Ordering information: This item can be ordered from DOI: 10.1007/978-3-030-31503-0_10 Access Statistics for this chapter More chapters in Springer Books from Springer |
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