Analyzing Longitudinal Clinical Trial Data: A Practical Guide provides practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice.
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.
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions.
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions.
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3).
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3).
Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials.
Statistical Thinking in Clinical Trials combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials.
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology.
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology.
Now fully updated for its fourth edition, Pharmacy: What It Is and How It Works continues to provide a comprehensive review of all aspects of pharmacy, from the various roles, pathways and settings of pharmacists to information about how pharmacy works within the broader health care system.
For more than five decades, scientists and researchers have relied on the Advances in Chromatography series for the most up-to-date information on a wide range of developments in chromatographic methods and applications.
For more than five decades, scientists and researchers have relied on the Advances in Chromatography series for the most up-to-date information on a wide range of developments in chromatographic methods and applications.
For more than five decades, scientists and researchers have relied on the Advances in Chromatography series for the most up-to-date information on a wide range of developments in chromatographic methods and applications.
Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009).
The study of pharmaceutical dosage forms has many connections to biological and medical sciences including physiology, biochemistry, pharmacology, pharmacotherapy, therapeutics, pharmacodynamics, pharmacokinetics, and pharmacognosy.
The study of pharmaceutical dosage forms has many connections to biological and medical sciences including physiology, biochemistry, pharmacology, pharmacotherapy, therapeutics, pharmacodynamics, pharmacokinetics, and pharmacognosy.
Now fully updated for its fourth edition, Pharmacy: What It Is and How It Works continues to provide a comprehensive review of all aspects of pharmacy, from the various roles, pathways and settings of pharmacists to information about how pharmacy works within the broader health care system.
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.
Highly recommended by CHOICE, Oct 2018Extremophiles are nature's ultimate survivors, thriving in environments ranging from the frozen Antarctic to abyssal hot hydrothermal vents.
For more than five decades, scientists and researchers have relied on the Advances in Chromatography series for the most up-to-date information on a wide range of developments in chromatographic methods and applications.
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.
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.
Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials.
Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials.
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies.
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting.
Properties and Formulation: From Theory to Real-World ApplicationScientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility.
Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC).
Martingale Methods in Statistics provides a unique introduction to statistics of stochastic processes written with the author's strong desire to present what is not available in other textbooks.
Integrating the clinical and engineering aspects of drug delivery, this book offers a much needed comprehensive overview and patient-oriented approach for enhanced drug delivery optimization and advancement.
