Biopharmaceutics Applications in Drug Development

In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval. Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics.

Biopharmaceutics Applications in Drug Development fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance. Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.

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Clean-in-Place for Biopharmaceutical Processes

An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.

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Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics: Homogeneous and Heterogeneous Approaches

The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with empirical, compartmental, and stochastic pharmacokinetic models, and the fourth mainly with nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. Many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods.

This timely and useful book will appeal to graduate students and researchers in pharmacology, pharmaceutical sciences, bioengineering, and physiology.

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Drug Absorption Studies: In Situ, In Vitro and In Silico Models

In the last 15 years, a great number of cell- or tissue-based in vitro models have been introduced into the biopharmaceutics arena. These models mimic the different biological barriers that a drug has to overcome to finally reach its target organ/cell/receptor. These in vitro models have been found very useful in not only characterising the permeability behaviour of drugs molecules in epithelial and endothelial tissues, but also studying drug delivery systems for improved delivery and enhanced absorption. Compared to the complex in vivo situation, in vitro models offer a fast, convenient approach with cost advantages most of times. Most importantly, they can be standardised and automatised to be applicable to the high-throughput screening.

Starting at the molecular level of studies, continuing with cell monolayer models (both primary and cell lines) and in situ techniques as a final testing format, the book provides a practical approach to contemporary in vitro techniques for drug absorption studies. In addition, chapters on high-throughput assays, in vitro-in vivo correlation, bioinformatics and regulatory issues are covered, giving a comprehensive overview of available models and techniques. Moreover, an appendix comprised with a number of practical protocols is available online, updated as needed, should prove very helpful to apply the techniques directly to the benchside.

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Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition

Thoroughly acquainting the reader with freeze-drying fundamentals-including water properties critical to the process and mechanisms and means of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures-ensuring the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation.

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Process Validation in Manufacturing Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages.

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Drug Absorption Studies: In Situ, In Vitro and In Silico Models

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In the last 15 years, a great number of cell- or tissue-based in vitro models have been introduced into the biopharmaceutics arena. These models mimic the different biological barriers that a drug has to overcome to finally reach its target organ/cell/receptor. These in vitro models have been found very useful in not only characterising the permeability behaviour of drugs molecules in epithelial and endothelial tissues, but also studying drug delivery systems for improved delivery and enhanced absorption. Compared to the complex in vivo situation, in vitro models offer a fast, convenient approach with cost advantages most of times. Most importantly, they can be standardised and automatised to be applicable to the high-throughput screening.

Starting at the molecular level of studies, continuing with cell monolayer models (both primary and cell lines) and in situ techniques as a final testing format, the book provides a practical approach to contemporary in vitro techniques for drug absorption studies. In addition, chapters on high-throughput assays, in vitro-in vivo correlation, bioinformatics and regulatory issues are covered, giving a comprehensive overview of available models and techniques. Moreover, an appendix comprised with a number of practical protocols is available online, updated as needed, should prove very helpful to apply the techniques directly to the benchside.

Encyclopedia of Biopharmaceutical Statistics, Second Edition

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Millennium Pharmaceuticals, Cambridge, MA. Resource offers more than 3,300 lists expanded to reflect amendments to regulatory requirements and recently developed statistical methods impacting the drug review/approval process and biopharmaceutical research and development. Offers more than 3,000 equations, tables, and figures. Previous edition not cited.

Handbook of Prebiotics

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In order to achieve optimal digestion, absorption, and nutritional health, we must have appropriate populations of positive microflora. Prebiotics are functional foods that improve health by fortifying indigenous probiotics within the gut. This fast-growing area of nutrition and microbiology is rapidly amassing data and answering many questions about the necessity and benefit of such functional foods.

Gathering contributions from leading experts in a range of disciplines,Handbook of Prebiotics presents a balanced view of the current knowledge in many different areas of the field. It discusses concept, definition and criteria for classification of a food component as prebioticsIt then describes interactions with gut microbiota. Highlighting varying levels of evidence and agreement, the book presents current arguments for and against prebiotic intake. Contributions discuss the biomechanics of prebiotics and their effects on immune status, serum lipid concentrations, mineral bioavailability, and satiety modulation. They consider the health implications of prebiotic intake such as reduced incidence of gastroenteritis and chronic pathogenic gut disorders, including intestinal cancers and inflammatory bowel diseases.

Providing well-rounded coverage, the book explores the varying effects of prebiotics in different populations and age groups such as infants and the elderly, as well as livestock and pets. The final chapters describe food avenues and the safety implications for prebiotic use. Spanning several disciplines including food science, nutrition, microbiology, biotechnology, and the health sciences, this seminal work makes a point to include sound research science and well-balanced views on the potential of prebiotics for promoting good health.