Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to clinical trial designs according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the...

This is a review of the methods for characterizing bioadhesive materials and for improving vehicle targeting and uptake - offering possibilities for reformulating existing compounds to create new pharmaceuticals at lower development costs. It evaluates the unique carrier characteristics of bioadhesive polymers and their power to enhance localization of delivered agents, local bioavailability, and drug absorption and transport.

Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and expanded to represent the most up-to-date studies in the field, this guide covers advances in pulsatile delivery systems, injectable microparticulate systems, and site-specific delivery systems, as well as potential therapeutic applications of...

Spanning every subject of critical importance to the field of environmental monitoring, this guide offers step-by-step guidance on the assessment of air, surfaces, water, action levels, instruments, and procedures in cleanroom facilities. Emphasizing the importance of data gleaned from evaluation and sampling studies, this guide shows how to use this information to reduce contamination risks and provide safe and stable operating conditions for the development of pharmaceutical products. This reference also covers certification/requalification and new ISO standards.

Emphasizing four major classes of polymers for drug delivery-water-soluble polymers, hydrogels, biodegradable polymers, and polymer assemblies-this reference surveys efforts to adapt, modify, and tailor polymers for challenging molecules such as poorly water-soluble compounds, peptides/proteins, and plasmid DNA.

The international popularity of herbal remedies has recently outpaced quality information on the utilization and dosing of these compounds. This book fills a void in the literature by offering an authoritative overview of the mechanisms of herbal remedies and their impact on standard medications. It offers a practical approach that focuses not only on specific drug interactions, but the mechanisms behind those interactions and their clinical significance. With contributions from leading experts on the subject, this text examines the overall use of herbs, includes sections on individual herbs,...

Increasing knowledge of oral lipid-based formulations has shown their utility for aiding gastrointestinal absorption and reducing or eliminating the effect of food on the absorption of poorly soluble, lipophilic drugs. Despite its promise for addressing the persistent and growing problems surrounding the oral delivery of numerous poorly water-soluble drug candidates, industry has been slow to apply and further develop this technology. This title provides a comprehensive summary of the theoretical and practical aspects of oral lipid-based formulations for use in industry and to give greater...

Presenting applications in clinical development, pharmacokinetic/ pharmacodynamic modelling and clinical trial simulation, this reference studies the role of biomarkers in successful drug formulation and development.