Dipolar Recoupling, by Niels Chr. Nielsen, Lasse A. Strasso and Anders B. Nielsen.-

Solid-State NMR Techniques for the Structural Determination of Amyloid Fibrils, by Jerry C. C. Chan.-

Solid-State 19F-NMR of Peptides in Native Membranes, by Katja Koch, Sergii Afonin, Marco Ieronimo, Marina Berditsch and Anne S. Ulrich.-

Probing Quadrupolar Nuclei by Solid-State NMR Spectroscopy: Recent Advances, by Christian Fernandez and Marek Pruski.-

Solid State NMR of Porous Materials Zeolites and Related Materials, by Hubert Koller and Mark Weiss.-

Solid-State NMR of Inorganic Semiconductors, by James P. Yesinowski.-"

This textbook on statistical modeling and statistical inference will assist advanced undergraduate and graduate students. Statistical Modeling and Computation provides a unique introduction to modern Statistics from both classical and Bayesian perspectives. It also offers an integrated treatment of Mathematical Statistics and modern statistical computation, emphasizing statistical modeling, computational techniques, and applications. Each of the three parts will cover topics essential to university courses. Part I covers the fundamentals of probability theory. In Part II, the authors introduce a wide variety of classical models that include, among others, linear regression and ANOVA models. In Part III, the authors address the statistical analysis and computation of various advanced models, such as generalized linear, state-space and Gaussian models. Particular attention is paid to fast Monte Carlo techniques for Bayesian inference on these models. Throughout the book the authors include a large number of illustrative examples and solved problems. The book also features a section with solutions, an appendix that serves as a MATLAB primer, and a mathematical supplement.

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements

Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification.

Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems

Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance--coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers--and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs

At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP).

Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Teaches proper procedures for using tools and analytical methods in a regulated lab setting
All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibration of instruments and validation of analytical methods. Following correct procedures ensures the generation of reliable data, which leads to the manufacture of safe and effective products.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions. Coverage includes: Method validation of potency, related substances, and dissolution testing Validation for pharmaceutical excipients, heavy metals, and bioanalysis Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters The LCMS system calibration Proper environmental chamber qualification Entire qualification process for computer equipment, hardware, and software Validation of Excel spreadsheets Regulatory requirements of the FDA, ICH, Europe, and Japan

Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment.

Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibrationscientists, and research and development scientists.

A comprehensive and up-to-date reference book on modern electric vehicle technology, which covers the engineering philosophy, state-of-the-art technology, and commercialisation of electrical vehicles.

This textbook on statistical modeling and statistical inference will assist advanced undergraduate and graduate students. Statistical Modeling and Computation provides a unique introduction to modern Statistics from both classical and Bayesian perspectives. It also offers an integrated treatment of Mathematical Statistics and modern statistical computation, emphasizing statistical modeling, computational techniques, and applications. Each of the three parts will cover topics essential to university courses. Part I covers the fundamentals of probability theory. In Part II, the authors introduce a wide variety of classical models that include, among others, linear regression and ANOVA models. In Part III, the authors address the statistical analysis and computation of various advanced models, such as generalized linear, state-space and Gaussian models. Particular attention is paid to fast Monte Carlo techniques for Bayesian inference on these models. Throughout the book the authors include a large number of illustrative examples and solved problems. The book also features a section with solutions, an appendix that serves as a MATLAB primer, and a mathematical supplement.

Dipolar Recoupling, by Niels Chr. Nielsen, Lasse A. Strasso and Anders B. Nielsen.-

Solid-State NMR Techniques for the Structural Determination of Amyloid Fibrils, by Jerry C. C. Chan.-

Solid-State 19F-NMR of Peptides in Native Membranes, by Katja Koch, Sergii Afonin, Marco Ieronimo, Marina Berditsch and Anne S. Ulrich.-

Probing Quadrupolar Nuclei by Solid-State NMR Spectroscopy: Recent Advances, by Christian Fernandez and Marek Pruski.-

Solid State NMR of Porous Materials Zeolites and Related Materials, by Hubert Koller and Mark Weiss.-

Solid-State NMR of Inorganic Semiconductors, by James P. Yesinowski.-"

Provides a comprehensive review of all types of medical therapeutic delivery solutions from traditional pharmaceutical therapy development to innovative medical device therapy treatment to the recent advances in cellular and stem cell therapy development- Provides information to potentially allow future development of treatments with greater therapeutic potential and creativity- Includes associated regulatory requirements for the development of these therapies- Provides a comprehensive developmental overview on therapeutic delivery solutions- Provides overview information for both the general reader as well as more detailed references for professionals and specialists in the field