Clinical pharmacology is the study of
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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. Show
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Rights and permissionsReprints and Permissions Copyright information© 2019 Springer Nature Switzerland AG About this chapterCite this chapterWeng, W., Fang, L. (2019). Design and Analysis of Clinical Pharmacology Studies. In: Fang, L., Su, C. (eds) Statistical Methods in Biomarker and Early Clinical Development. Springer, Cham. https://doi.org/10.1007/978-3-030-31503-0_10 What is the pharmacology the study of?Broadly defined, pharmacology is a discipline that deals with mechanisms of action of naturally occurring mediators and drugs at the level of the whole organism and the cell. Often confused with pharmacology, pharmacy is a separate discipline in the health sciences.
What subjects are in clinical pharmacology?Clinical Pharmacology is inherently a translational discipline underpinned by the basic science of pharmacology, engaged in the experimental and observational study of the disposition and effects of drugs in humans, and committed to the translation of science into evidence-based therapeutics.
What is clinical pharmacology quizlet?Definition. 1 / 40. the biomedical study of the interaction of chemical substances with living systems including cells, tissues, and organisms.
What is the role of clinical pharmacologist?Clinical pharmacology and therapeutics doctors promote and ensure the safe, economic and efficient use of medicines to improve patient care. You'll provide specialist advice to colleagues and patients to help improve the outcome of a patient's treatment and overall experience.
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