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.
Explore Important Tools for High-Quality Work in Pharmaceutical SafetyStatistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data.
The six years that have passed since the publication of the first edition have brought significant advances in both biofilm research and biofilm engineering, which have matured to the extent that biofilm-based technologies are now being designed and implemented.
The use of the chemical modification of proteins has evolved over the past 80 years, benefiting from advances in analytical, physical, and organic chemistry.
A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain.
A natural long-chain polymer, chitin is the main component of the cell walls of fungi, the exoskeletons of arthropods (including crustaceans and insects), the radulas of mollusks, and the beaks and internal shells of cephalopods.
Take Your NI Trial to the Next LevelReflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial.
This book explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies.
State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve
The biopharmaceutical industry as we know it today is going through a massive upheaval as a result of the uncertainty of healthcare reform and increasing regulatory pricing pressure.
The New Benchmark for Understanding the Latest Developments of Ion ChannelsIon channels control the electrical properties of neurons and cardiac cells, mediate the detection and response to sensory stimuli, and regulate the response to physical stimuli.
A Proactive Approach to Improving and Protecting the EnvironmentThe accumulation of pharmaceuticals in the environment is a growing concern, the magnitude of which has not been determined, yet cannot be ignored.
The regenerative capacity of the liver has been recognized for centuries, but when it is overwhelmed by insulting stimuli or is chronically damaged, its regenerative capability is substantially reduced or lost.
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).
Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies.
Used routinely in drug control laboratories, forensic laboratories, and as a research tool, thin layer chromatography (TLC) plays an important role in pharmaceutical drug analyses.
Adaptive Designs for Sequential Treatment Allocation presents a rigorous theoretical treatment of the results and mathematical foundation of adaptive design theory.
Interval-Censored Time-to-Event Data: Methods and Applications collects the most recent techniques, models, and computational tools for interval-censored time-to-event data.
If we will ever achieve Paul Ehrlich's "e;magic bullet,"e; that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change.
This reference book examines the role of biotechnological innovations in achieving global health targets, addressing disease burdens, and fostering a sustainable healthcare ecosystem for promoting good health and wellbeing.
This book provides a comprehensive understanding of streptomycetes, highlighting their various habitats, diversity, genetic structure, and metabolic engineering techniques to enhance the production of secondary metabolites.
As the pharmaceutical industry navigates this new era of technological innovation, the integration of AI, big data, and advanced analytics into clinical trials holds immense potential to transform drug development.
This concise text on biologically active substances of the food, pharmaceutical and agricultural industries presents data on natural compounds of vegetable and animal origin.
This book is intended to help decision-makers use, assess and appraise the evidence that underpins decisions about the use of therapeutic interventions.
Carbon-Based Nanocarriers for Drug Delivery enlists the latitudes and advancements in the synthesis processes, functionalization, and applications of carbon-based nanomaterials (CBNs) in targeted drug delivery systems (DDSs).
-Carbolines: A Privileged Scaffold for Modern Drug Discovery provides a summary of methods for the synthesis of various natural products engineered with the diverse -carboline scaffold and their biological evaluation.
A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain.
A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today.
Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments.
Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization.
Antibodies protect us from a wide range of infectious diseases and cancers and have become an indispensable tool in science-both for conventional immune response research as well as other areas related to protein identification analysis.
Advances in genomics and combinatorial chemistry during the past two decades inspired innovative technologies and changes in the discovery and pre-clinical development paradigm with the goal of accelerating the process of bringing therapeutic drugs to market.
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed.
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy.