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Real-World Evidence in Medical Product Development
This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.
Pharmaceutical Statistics Using SAS
Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.
Causal Inference in Pharmaceutical Statistics
Causal Inference in Pharmaceutical Statistics introduces the basic concepts and fundamental methods of causal inference relevant to pharmaceutical statistics. This book covers causal thinking for different types of commonly used study designs in the pharmaceutical industry, including but not limited to randomized controlled clinical trials, longitudinal studies, singlearm clinical trials with external controls, and real-world evidence studies. The book starts with the central questions in drug development and licensing, takes the reader through the basic concepts and methods via different study types and through different stages, and concludes with a roadmap to conduct causal inference in cl...
The Bermudian
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Real World Health Care Data Analysis
Discover best practices for real world data research with SAS code and examples Real world health care data is common and growing in use with sources such as observational studies, patient registries, electronic medical record databases, insurance healthcare claims databases, as well as data from pragmatic trials. This data serves as the basis for the growing use of real world evidence in medical decision-making. However, the data itself is not evidence. Analytical methods must be used to turn real world data into valid and meaningful evidence. Real World Health Care Data Analysis: Causal Methods and Implementation Using SAS brings together best practices for causal comparative effectiveness...
Polypharmacy in Psychiatry Practice, Volume I
Although monotherapy is generally recommended as the treatment of choice, treatment resistance of patients with psychosis, cognitive, mood and anxiety disorders represents a significant clinical problem. In this context, augmentation and combination strategies are commonly employed to address this problem. Although multiple medication use common in psychiatric practice, reasons, efficacy and safety for polypharmacy, and augmentative strategies have remained unclear. It remains unclear if there is an evidence base to support polypharmacy. Furthermore, excessive and inappropriate use of psychotropic medications has been recognized as a public health problem. This volume set is the first comprehensive, clinically oriented, reference on the multiple medication use to treat psychotic, cognitive, mood and anxiety disorders.
New Horizons in Health-Promoting Technologies: From Development to Rational Use
This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact.
