Technologies and Innovations for Sustainable Development offers a comprehensive exploration of cutting-edge solutions that can help us build a greener, more equitable future.
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars.
Due to the tremendous accumulation of data for genetic markers, pharmacogenomics, the study of the functions and interactions of all genes in the overall variability of drug response, is one of the hottest areas of research in biomedical science.
Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing.
Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial.
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates.
Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications.
The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies.
Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninformative priors as well as the modern innovations of adaptive randomization and predictive power.
Randomised Response-Adaptive Designs in Clinical Trials presents methods for the randomised allocation of treatments to patients in sequential clinical trials.
With the prevalence of viral diseases causing significant health challenges and the emergence of highly infectious and difficult-to-treat conditions, such as Ebola, HIV/AIDS, and Hepatitis B, there is a pressing need for effective antiviral treatments.
Specialists drawn from industry, agency and academia explain the role of the various elements in the marketing communications process, and show how a reassessment of the marketing mix can result in a positive response to challenges imposed by a changing commercial environment.
Based on the authors' experiences of working with a wide variety of retail pharmacies, this book is designed to provide pharmacists with a clear understanding of the nature of marketing, and the ways it can contribute to the effective management of their business.
The third edition of this popular and highly-regarded guide uncovers the ethics, conventions and often unwritten rules of publishing in peer-reviewed journals and at conferences.
Praise for the first edition:"e;Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book-not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC.
Nature is an attractive source of therapeutic and preventive compounds, and with such chemical diversity found in millions of species of plants, over 60% of currently used anticancer agents are derived from natural sources.
Highly recommended by CHOICE, Oct 2018Extremophiles are nature's ultimate survivors, thriving in environments ranging from the frozen Antarctic to abyssal hot hydrothermal vents.
Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development.
Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development.
Dynamic Treatment Regimes: Statistical Methods for Precision Medicine provides a comprehensive introduction to statistical methodology for the evaluation and discovery of dynamic treatment regimes from data.
Since the discovery of Aquaporin-1 (AQP1) as a water channel, many studies have revealed the importance of aquaporins in mammalian physiology and pathophysiology as well as plant and microbial biology.
Review of the First Edition"e;The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods.
A follow-up to the experimental and instrumental aspects described in Basic Principles of Analytical Ultracentrifugation, the volume Sedimentation Velocity Analytical Ultracentrifugation: Discrete Species and Size-Distributions of Macromolecules and Particles describes the theory and practice of data analysis.
In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine.
Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks.
Written by more than 400 subject experts representing diverse academic and applied domains, this multidisciplinary resource surveys the vanguard of biomaterials and biomedical engineering technologies utilizing biomaterials that lead to quality-of-life improvements.
Cancer is a major healthcare burden across the world and impacts not only the people diagnosed with various cancers but also their families, carers, and healthcare systems.
Biomedical Application of Nanoparticles explores nanoparticles, their chemical and physicals properties, and how they interact in biological systems with proteins, immune system and targeted cells.
Hydrogels are crosslinked, macromolecular polymeric materials arranged in a three-dimensional network, which can absorb and retain large amounts of water.
As the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States.
