With worked examples and problems based on real-world scenarios, this book takes readers through the process of calculating the sample size for many types of clinical trials. It covers the most common types of clinical trials across all phases. The author discusses how assumptions made in a sample size calculation can impact the calculation. He provides calculations for many of the trials and offers hints and tips on how to optimize the calculations. He also illustrates the steps involved in determining sample size, from defining the trial objective to selecting an appropriate endpoint.
This Second Edition is the premier name resource in the field. It provides a handy resource for navigating the web of named reactions and reagents. Reactions and reagents are listed alphabetically, followed by relevant mechanisms, experimental data (including yields where available), and references to the primary literature. The text also includes three indices based on reagents and reactions, starting materials, and desired products. Organic chemistry professors, graduate students, and undergraduates, as well as chemists working in industrial, government, and other laboratories, will all find this book to be an invaluable reference.
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized.
Provides basic training in the whole analytical process for students, demonstrating why analysis is necessary and how to take samples, before they attempt to carry out any analysis in the laboratory.
This handy reference provides insight into the approach used to identify the stability profile of a molecule that comes at the end of the drug registration process, and supplies an in-depth review of the mechanisms and associated causes of protein instability likely to be encountered during drug formulation development. Emphasizes the importance of selecting formulation conditions, excipients, and container closure systems to minimize degradation processes and maximize shelf stability! Organized to direct scientists new to the field of protein formulation to appropriate starting points of drug development, Protein Formulation and Delivery · includes a discussion of accelerated stability testing and its limitations in identifying stable formulations · details analytical methods commonly used in stability assessment and formulation development · stresses the importance of demonstrating the stability-indicating nature of an assay · describes the drug substance manufacturing process succinctly · examines preformulation and development of traditional solution and lyophilized formulations intended for intravenous administration · covers aseptic processing in drug development and the potential development of a freeze-drying cycle · explores the development of nontraditional formulations, alternate routes of drug delivery, and controlled release dosage forms · discusses the physical and chemical characteristics of proteins in microsphere delivery systems · analyzes protein degradation mechanisms, and methods of detecting and monitoring degradation · explores formulations intended for injection, inhalation, and controlled delivery · and more! Presenting over 660 references and an extensive literature review valuable to scientists at every level, Protein Formulation and Delivery is an indispensable guide for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers; and upper-level undergraduate and graduate students in these disciplines.
This book considers modern concepts of the chromatography of high-molecularweight compounds and its main theoretical and methodological features. Recommendations are given for the preparation of high-performance chromatographic systems and the choice of the optimum conditions for their operation. Particular attention is directed to the problems of the interpretation of chromatographic data with the aim of obtaining various molecular-weight and structural characteristics of the macromolecules investigated: AMW, MWD, indices of polymer branching, the compositional homogeneity of copolymers, the functionality of oligomers, etc. Examples are given of various combinations of chromatographic and other methods that can be used to analyse complex polymer systems. The applications of chromatography to the study of the process of association of the macromolecules and the determination of the porous structure of sorbents are demonstrated. The progress of modern chromatographic methods and the preparation of highly efficient sorbents and polymer standards is reviewed. The book is intended for research workers and technologists.
These guidelines have been published to assist national laboratories and other relevant scientific institutions in obtaining, in a timely fashion, the reference standards that they require. They address some of the most frequently encountered difficulties.
The rapidly expanding growth of the literature on chromatography, capillary electrophoresis, field flow fractionation, and other separation techniques makes it difficult for any individual to maintain a coherent view of progress in the field. Rather than attempt to read the avalanche of original research papers, investigators trying to preserve even a modest awareness of advances must rely upon authoritative surveys. Featuring reliable, up-to-the-minute reviews of major developments in chromatography and other separation techniques, this critically praised series separates the most important advances from an overabundance of supplementary materials.
Filling a gap in the pharmaceutical literature, this unique guide addresses the development of targeted methodologies to monitor impurities in pharmaceutical compounds and drug products. Furnishes physicochemical protocols to determine the purity of pharmaceutical compounds fully before pharmacological and toxicological studies begin! Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals introduces various techniques for isolating and characterizing impurities presents guidelines to evaluate stability using kinetic studies shows how to develop stability-indicating methodologies details various methods that require minimal sample prepreparation gives regulatory perspectives on chiral impurities and more! Containing important literature citations and offering an invaluable list of applications, Impurities Evaluation of Pharmaceuticals is an outstanding resource for pharmacists and pharmacologists, clinical microbiologists, quality assurance and production managers in the pharmaceutical industry, analytical chemists and biochemists, pharmaceutical regulatory personnel, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.
