This book provides a unique knowledge source of the FDA's regulatory processes to anyone interested in the development and approval of biomedical products.
The confluence of big data, artificial intelligence (AI), and machine learning (ML) has led to a paradigm shift in how innovative medicines are developed and healthcare delivered.
This unique book provides a thorough overview of developing molecular cancer diagnostic assays, which are the prerequisites for optimal solutions within personalized cancer medicine.
In 1900 only a handful of drugs (morphine, quinine, aspirin, etc) had genuine efficacy but had little value for bacterial or viral infections or cancer.
Insights and analysis that challenge current thought on consumer branding theory and strategy Pharmaceutical companies need to go beyond simply relying on strong sales forces and innovative research and development to succeed.
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.
This book provides a comprehensive introduction to advanced drug delivery and targeting, covering their principles, current applications, and potential future developments.
After the drug discovery and development process, designing suitable formulations to safely deliver the optimum dose, while avoiding side effects, has been a constant challenge, especially when drugs are very toxic and have poor solubility and undesirable clearance profiles.
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.
This reference features the latest findings surrounding the physicochemical aspects of surfactant and polymer systems to facilitate the design and understanding of novel and advanced drug delivery formulations.
Liposome Technology, Volume III: Interactions of Liposomes with the Biological Milieu, Third Edition, is a comprehensively updated and expanded new edition of a classic text in the field.
Design Principles and Analysis Techniques for HRQoL Clinical TrialsSAS, R, and SPSS examples realistically show how to implement methods Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical meth
Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods.
This book provides a summarized information related to the global herbal drug market and its regulations, ethnopharmacology of traditional crude drugs, isolation of phytopharmaceuticals, phytochemistry, standardization, and quality assessment of crude drugs.
This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage.
Since the completion of the first edition of this book, major developments have occurred in the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy.
This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments.
As pharmaceutical companies look to develop single enantiomers as drug candidates, chemists are increasingly faced with the problems associated with this subclass of organic synthesis.
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.
Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments.
Nature gives us ample opportunity to understand and observe her secrets, and scientists and inventors can and do study the characteristics of things in nature to come up with amazing and astonishing technologies and products invented as a result.
An ideal text for biotechnologists, protein chemists, and biochemists, Functional Protein Microarrays in Drug Discovery explores all aspects of functional protein microarrays, including basic principles, methods, and 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.
Written for drug developers rather than computer scientists, this monograph adopts a systematic approach to mining scientifi c data sources, covering all key steps in rational drug discovery, from compound screening to lead compound selection and personalized medicine.
PREFACE TO THE SECOND EDITIONThe need for a thorough understanding of medical terminology has not diminished in the least for pharmacists and other health care practitioners in the five years between the publication of the first edition of this book and this second edition.
The First International Medical Case Reports Conference, 2024(IMED-C) was a pioneering event set to redefine the landscape of medical research and case reporting.
Extensively revised and updated, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition reflects the logarithmic progress made in the past four years of oligonucleotide-based therapies, and, in particular, antisense therapeutics and research.
After the drug discovery and development process, designing suitable formulations to safely deliver the optimum dose, while avoiding side effects, has been a constant challenge, especially when drugs are very toxic and have poor solubility and undesirable clearance profiles.
This comprehensive and useful handbook represents a definitive up-to-date compendium of key in vitro bioassay methods that are employed to quantify and validate the anticancer activity of a drug candidate before it makes its way in to animal or clinical trials.
Rapid, inexpensive, and easy-to-deploy, near-infrared (NIR) spectroscopy can be used to analyze samples of virtually any composition, origin, and condition.
This book has evolved over the last twenty years from a cumulative effort to develop a professional course in pharmacokinetics that would assist future practitioners in therapeutic decision making.
This first volume of Metal-Organic Framework Composites focusses on pharmaceutical pollution as an issue of concern due to its effects on the environment and the application of MOFs for remediation.
Biosensors: Fundamentals, Emerging Technologies, and Applications provides insight into the sensing applications of different types of biosensors relating to environmental pollutants, microbiological analysis, and healthcare.
Written and edited by experts in the field, this book brings together the current state of the art in phenotypic and rational, target-based approaches to drug discovery against pathogenic protozoa.
Pharmaceutical Dosage Forms: Tablets, Volume 1examines the fundamental physical and chemical processes that the different unit oprations use, and then applies this knowledge to the discussion of the varying unit operations and processes.
