The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.

This book provides an up to date review on antimicrobials dosing in obese patients, including practice recommendations for clinical use. The book is written by a group of doctors and pharmacists working in infectious diseases practice and research. The introductory chapter outlines the important physiological changes in obesity including factors affecting the dosing of antimicrobials in obese patients. The introductory chapter is followed by ten chapters covering the major classes of antibiotics, antifungals, and antivirals. Each chapter briefly discusses the pharmacokinetics changes related to obesity and a summary of the relevant up-to-date literature. Specific dosing recommendations are provided for each class supplemented by real-life examples as clinical cases that are included as an appendix to the book. The book is a useful resource for clinicians, students and researchers needing up-to-date information on antimicrobial dosing in obese patients. Doctors, pharmacists, nurses working in hospital settings, and students of health courses (medical, pharmacy and nursing students) will find this book particularly useful.

The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Originally published in French, this updated and expanded English translation offers a definitive treatment on clays and effects on human health including the long history of clays used as pharmaceutical and therapeutic agents, the origins of clays, their structural properties and modes of action.

This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation of new cytometry methods. Expertly curated by two practicing professionals in drug development and biotherapeutics, individual chapters are selected for novel and sound research; information is chosen based on its relevance to lab applications and clinical trials, such as the topic of selecting animal models for their relevancy to humans. The book is multifaceted, discussing the ethics and issues with biospecimens and providing an in-depth analysis to the differences between pre-clinical and clinical assay development. The book is an essential read for general readers who need an introduction to the history and background of biomarkers, and it also provides critical analyses of various new validation methods for practitioners and researchers.

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors.

This title is a comprehensive text that addresses key aspects of nanomedicine such as properties occurring at the nanoscale that have unique medical effects, great molecular knowledge of the human body and disease processes, and apparent clinical translation as opposed to narrow insufficient texts that address only a few topics and attempt to "rebrand" established drug delivery. It will clearly define the field which is needed due to the immaturity and broad nature of the field. The book is aligned with both the USA and European roadmaps for nanomedicine and will address initiatives taken in Asia that ensures timely and relevant content. In-depth chapters ensure each section is adequately covered. The nanopharmaceutical section focuses on novel drug delivery systems relevant to nanomedicine and the book has an extensive section on immune recognition at the nanoscale which has implications for in vivo applications of nanomedicines.

This second edition volume expands on the first edition by providing up-to-date protocols to characterize nanomaterials used as drug delivery agents. The chapters in this book are divided into 5 parts and cover topics such as: advances and obstacles in nanomedicine research; methods to test sterility and endotoxin, physicochemical features, immunological effects, drug release, and in vivo efficacy. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Cutting-edge and comprehensive, Characterization of Nanoparticles Intended for Drug Delivery, Second Edition is a valuable tool for researchers and pharmaceutical and biotechnology developers who are evaluating the clinical potential of nanomedicines in preclinical studies.>

The first contribution presents coumarins, the largest group of 1-benzopyran derivatives found in plants. Coumarin chemistry remains one of the major interest areas of phytochemists, especially because of their structural diversity and medicinal properties, along with the wide-ranging bioactivities of these compounds, inclusive of analgesic, anticoagulant anti-HIV, anti-inflammatory, antimicrobial, antineoplastic, antioxidant, and immunomodulatory effects. The second contribution presents a comprehensive survey of the many aspects of PAD biochemistry and physiology. The third contribution gives a comprehensive overview of secondary metabolites from higher fungi, with more than 700 references highlighting the isolation, structure elucidation, biological activities, chemical synthesis, and biosynthesis of pigments, nitrogen-containing compounds, and terpenoids from mushrooms.

This is the first concise book that includes different aspects of naturally-derived components for wound healing. It presents the first exhaustive review of modern techniques in wound dressing development. With a growing, ageing population and the rapid growth of the wound-care market, the authors explore the current trend of bio-based products (active components and host materials) in this field. After a short introduction into modern solutions in wound-care and modern techniques in wound-dressing development, the authors, leaders in the field, explore natural-based components (drugs, extracts, materials etc.); safety and efficiency assessments (biocompatibility, cytotoxicity and in vitro performance etc.); and model films as a platform for the development of new wound dressings.

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors.

In medical and health care the scientific method is little used, and statistical software programs are experienced as black box programs producing lots of p-values, but little answers to scientific questions. The pocket calculator analyses appears to be, particularly, appreciated, because they enable medical and health professionals and students for the first time to understand the scientific methods of statistical reasoning and hypothesis testing. So much so, that it can start something like a new dimension in their professional world. In addition, a number of statistical methods like power calculations and required sample size calculations can be performed more easily on a pocket calculator, than using a software program. Also, there are some specific advantages of the pocket calculator method. You better understand what you are doing. The pocket calculator works faster, because far less steps have to be taken, averages can be used. The current nonmathematical book is complementary to the nonmathematical "SPSS for Starters and 2nd Levelers" (Springer Heidelberg Germany 2015, from the same authors), and can very well be used as its daily companion.

This thesis investigates a range of experimental and computational approaches for the discovery of solid forms. Furthermore, we gain, as readers, a better understanding of the key factors underpinning solid-structure and diversity. A major part of this thesis highlights experimental work carried out on two structurally very similar compounds. Another important section involves looking at the influence of small changes in structure and substituents on solid-structure and diversity using computational tools including crystal structure prediction, PIXEL calculations, Xpac, Mercury and statistical modeling tools. In addition, the author presents a fast validated method for solid-state form screening using Raman microscopy on multi-well plates to explore the experimental crystallization space. This thesis illustrates an inexpensive, practical and accurate way to predict the crystallizability of organic compounds based on molecular structure alone, and additionally highlights the molecular factors that inhibit or promote crystallization.

This volume of Modern Aspects of Electrochemistry reviews the latest developments in electrochemical science and technology related to biomedical and pharmaceutical applications. In particular, this book discusses electrochemical applications to medical devices, implants, antimicrobially active materials, and drug delivery systems.

This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application. The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.