Focused manuscript on the potential use/role of miRNAs in bioprocessing, specifically the production of complex proteins in mammalian cells. With that in mind I propose a draft list of topics/chapters along the following lines: Intro on CHO/bioprocessing/engineering challenges to set scene, Genomic organization, biogenesis and mode of action, Identifying miRNA targets: Computational prediction, transcriptomics, proteomices, UTR analysis, etc., miRNA expression in Chinese Hamster Ovary cells, miRNAs as engineering targets: pathway manipulation to impact bioprocess phenotypes, miRNAs as biomarkers, Detection methods: Northern, PCR, hybridization arrays, Next Gen Seq, Manipulation of expression in cultured cells: Transient/stable disregulation, Knockout.

The book "Nanocosmetics and nanomedicines: new approaches for skin care" contains a summary of the most important nanocarriers for skin delivery. Although "nanocosmetics" is a subject widely commented in the academy and the beauty industry, a book covering the skin care treatments using nanotechnological approaches with cosmetics and nanomedicines is still missing, therefore the need for this publication. This book is divided in three parts: The first one (Part A) is devoted to a brief review on the main topics related to the skin delivery and to the introduction of the subject "nanocosmetics". The second part (Part B) presents different types of nanocarriers applied as skin delivery systems for cosmetics or drugs. The last part (Part C) shows a wide range of applications of nanotechnology on the skin care area as well as on dermatocosmetic and dermatological fields.

This book provides up-to-date information on the development and progression of hepatocellular carcinoma (HCC) with a review of the cellular and molecular mechanisms involved in the disease process. Recent research in HCC has led to significant progress in our understanding of the cellular processes and molecular mechanisms that occur during multi-stage events that lead to hepatocarcinogenesis. The emergence of micro RNAs and molecular targeted therapies have added a new dimension in our efforts to combat this deadly disease, Chapters include discussion and evaluation of current intervention strategies and therapeutic options and a focus on the novel approaches that are being pursued, such as micro-RNA based therapies and personalized medicine to treat liver cancer. This book will be of interest to basic and clinical researchers, as well as to drug developers.

This book investigates the relationship between phytoconstituents and properties in specific plants, such as Hibiscus rosa sinesis, Cuscuta reflexa, Citrullus colocynthis, Nardostachys jatamansi and Ocimum gratissimum, that are used in hair care products including shampoos, conditioners, dyes, and oils. It explains the impact of these materials on the growth, structure, appearance, and health of hair. It also explores how the chemistry of certain plants from sustainable sources is exploited for use in hair products and nutraceuticals. Additionally, the authors include information on ingredients used for formulating 'green' hair products that treat common conditions such as canities, dandruff and alopecia.

The use of honey can be traced back to the Stone Age. Evidence can be found for its nutritional and medicinal use beginning with prehistoric and ancient civilizations. Currently, there is a resurgence of scientific interest in natural medicinal products, such as honey, by researchers, the medical community, and even the general public. Honey in Traditional and Modern Medicine provides a detailed compendium on the medical uses of honey, presenting its enormous potential and its limitations. The book covers honey's ethnomedicinal uses, chemical composition, and physical properties. It discusses the healing properties of honey, including antimicrobial, anti-inflammatory, and antioxidant properties. It also examines the botanical origin of honey, a critical factor in relation to its medicinal use, along with the complex subject of the varying composition of honey. Honey's antibacterial qualities and other attributes are described in a chapter dedicated to Leptospermum, or Manuka honey, a unique honey with potential for novel therapeutic applications. Chapters explore a variety of medicinal uses for honey, including its healing properties and use in burn and wound management. They review honey's beneficial effects on medical conditions, such as gastrointestinal disorders, cardiovascular diseases, diabetic ulcers, and cancers as well as in pediatrics and animal health and wellness. The book also examines honey-based formulations, modern methods for chemical analysis of honey, and the history and reality of "mad honey." The final chapters cover honey in the food industry, as a nutrient, and for culinary use.

A vast number of diagnostic and therapeutic decisions are based on measuring blood concentrations of molecules, yet most biochemical and pharmacological events actually take place in the tissues. Microdialysis is a key semi-invasive sampling technique to measure in vivo drug penetration to the target site in humans, the method being feasible in virtually every organ. Authored by international experts in this cutting edge field, this book will provide a comprehensive overview of microdialysis and its application for measuring drug distribution in drug development.

Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOP's, regulatory guidance's/guidelines, project teams, technical and department processes, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies.

"About 25 years ago, Mosmann & Coffman introduced the TH1 / TH2 paradigm of T helper cell differentiation which helped explain many aspects of adaptive immunity from eliminating intracellular versus extracellular pathogens to induction of different types of tissue inflammation. However, TH1 / TH2 paradigm could not adequately explain development of certain inflammatory responses which provided impetus for the discovery of a new subset of T cells called TH17 cells. After the discovery of differentiation and transcription factors for TH17 cells, it was clear that TH17 cells represent an independent subset of T cells with specific functions in eliminating certain extracellular pathogens, presumably not adequately handled by TH1 or TH2 cells. The major role of TH17 cells has been described in inducing auto-immune tissue inflammation. The discovery of TH17 cells has expanded the TH1 / TH2 paradigm, and the integration of TH17 cells with TH1 and TH2 effector T cells is beginning to explain the underlying mechanisms of tissue inflammation in a number of infections and auto-immune disease settings." - From Chapter One by Vijay K. Kuchroo, Harvard University, USA "The recently identified Interleukin 17 (IL-17) cytokine family contributes to immunity to infectious diseases and chronic inflammatory diseases. Further studies on the regulation and function of this important cytokine family may provide better understanding on the roles of the IL-17 family in immune-mediated diseases; such knowledge may lead to the development of immunotherapeutic strategies for treatment of several inflammatory diseases." - From Chapter Two by Chen Dong, University of Texas and MD Anderson Cancer Center, USA

Extensive experimentation and high failure rates are a well-recognised downside to the drug discovery process, with the resultant high levels of inefficiency and waste producing a negative environmental impact. Sustainable and Green Approaches in Medicinal Chemistry reveals how medicinal and green chemistry can work together to directly address this issue. After providing essential context to the growth of green chemistry in relation to drug discovery in Part 1, the book goes on to identify a broad range of practical methods and synthesis techniques in Part 2. Part 3 reveals how medicinal chemistry techniques can be used to improve efficiency, mitigate failure and increase the environmental benignity of the entire drug discovery process, whilst Parts 4 and 5 discuss natural products and microwave-induced chemistry. Finally, the role of computers in drug discovery is explored in Part 6.

Heparins remain amongst the most commonly used drugs in clinical practice. Almost 100 years have passed since the initial discovery of this complex substance and, during this time, understanding of the nature and uses of heparin and related molecules has grown dramatically. The aim of this volume is to summarise the developments that have led to the current status of both heparins as drugs and the field of heparin research, with a focus on the particularly rapid progress that has been made over the past three decades. Individual sections are dedicated to the nature of heparin as a biological molecule, the current approaches and techniques that are used to ensure the safety and reliability of heparin as a medicine, the clinical pharmacology of heparin as an anticoagulant drug, effects and potential applications of heparin aside of those involving haemostasis and, finally, the nature and potential uses of heparin-like materials from both natural and synthetic sources.

ABPP Methodology: Introduction and Overview, by Matthew B. Nodwell und Stephan A. Sieber Activity-Based Protein Profiling for Natural Product Target Discovery, by Joanna Krysiak und Rolf Breinbauer Photoaffinity Labeling in Activity-Based Protein Profiling, by Paul P. Geurink, Laurette M. Prely, Gijs A. van der Marel, Rainer Bischoff und Herman S. Overkleeft Application of Activity-Based Protein Profiling to the Study of Microbial Pathogenesis, by William P. Heal und Edward W. Tate Functional Analysis of Protein Targets by Metabolomic Approaches, by Yun-Gon Kim und Alan Saghatelian

Introduction to Fragment-Based Drug Discovery, by Daniel A. Erlanson

Fragment Screening Using X-Ray Crystallography, by Thomas G. Davies and Ian J. Tickle

Hsp90 Inhibitors and Drugs from Fragment and Virtual Screening, by Stephen Roughley, Lisa Wright, Paul Brough, Andrew Massey and Roderick E. Hubbard

Combining NMR and X-ray Crystallography in Fragment-Based Drug Discovery: Discovery of Highly Potent and Selective BACE-1 Inhibitors, by Daniel F. Wyss, Yu-Sen Wang, Hugh L. Eaton, Corey Strickland, Johannes H. Voigt, Zhaoning Zhu and Andrew W. Stamford

Combining Biophysical Screening and X-Ray Crystallography for Fragment-Based Drug Discovery, by Michael Hennig, Armin Ruf and Walter Huber

Targeting Protein Protein Interactions and Fragment-Based Drug Discovery, by Eugene Valkov, Tim Sharpe, May Marsh, Sandra Greive and Marko Hyvonen

Fragment Screening and HIV Therapeutics, by Joseph D. Bauman, Disha Patel and Eddy Arnold

Fragment-Based Approaches and Computer-Aided Drug Discovery, by Didier Rognan"

Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.

Long acting veterinary formulations play a significant role in animal health, production and reproduction within the animal health industry. Such technologies offer beneficial advantages to the veterinarian, farmer and pet owner. These advantages have resulted in them growing in popularity in recent years. The pharmaceutical scientist is faced with many challenges when innovating new products in this demanding field of controlled release. This book provides the reader with a comprehensive guide on the theories, applications, and challenges associated with the design and development of long acting veterinary formulations. The authoritative chapters of the book are written by some of the leading experts in the field. The book covers a wide scope of areas including the market influences, preformulation, biopharmaceutics, in vitro drug release testing and specification setting to name but a few. It also provides a detailed overview of the major technological advances made in this area. As a result this book covers everything a formulation scientist in industry or academia, or a student needs to know about this unique drug delivery field to advance health, production and reproduction treatment options and benefits for animals worldwide.

The enormous potential of siRNA as a therapeutic has led to an explosion of interest from the scientific community. There has been intense interest from Big Pharma to capitalise on this new technology but the fact remains that delivery is a key determinant in realizing the full clinical potential of RNA interference. There is an urgent need for better delivery methods to take this technology forward. This book addresses the role of different RNAi molecules in cellular processes as rational for diagnostic and therapeutic approaches. This book will cover RNAi therapeutic design to optimize siRNA potency and reduce off-target effects and current delivery technologies to overcome both intracellular and extracellular barriers. The reader will gain an insight into RNA interference from the cellular mechanisms to screening to siRNA design right through to diagnostic and therapeutic applications.

The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.

Controlled Release in Oral Drug Delivery provides focus on specific topics, complementing other books in the initial CRS series. Each chapter sets the context for the inventions described and describe the latitude that the inventions allow. In order to provide some similar look to each chapter, the coverage includes the historical overview, candidate drugs, factors influencing design and development, formulation and manufacturing and delivery system design. This volume was written along three main sections: the relevant anatomy and physiology, a discussion on candidates for oral drug delivery and the major three groups of controlled release systems: diffusion control (swelling and inert matrices); environmental control (pH sensitive coatings, time control, enzymatic control, pressure control) and finally lipidic systems.

Finally - a book that covers all aspects of the illicit use of cocaine, amphetamines, ecstasy and/or designer drugs such as GHB, written by two experts in their field. The use of these drugs remains a continuous threat in health and medical care delivery, and this book will be an essential asset to the physician who may have to face the evaluation of patients whose use of these drugs compromises an effective treatment plan for other health issues. The book has been conceived to fill the void in existing physician reference materials, and provides a comprehensive review of the theoretical knowledge and scope of pharmacotherapy in individuals who are hooked on a psychoactive substance. While detailed scientific information is obtainable in other major articles, the book's straightforward format and style, along with its illustrations, will make for easy reading as emphasis is put on information specifically related to drugs that occur most abused in today's society. The information provided is based on clinical practice rather than pure experimental data, which will give the physician more effective tools useful in their daily practice. Many mechanisms of action of abuse are described in detail and references are provided to direct the reader to further sources for additional information. As a special feature, the book incorporates uncluttered tables and charts, which result in immediate clarification of the mode of action on the central nervous system and the reason for misuse, thus avoiding usual long and fatiguing text in common reference books. The book aims to give the reader a clear and concise plan on what to do when being faced with an overdose situation. A well-organized Table of Contents rapidly leads the reader from general pharmacological issues to the specific overdose syndrome and its management. Additionally, significant emphasis is placed on the practical do's and don'ts for physicians, with special reference to the predictive signs of aberrant drug-related behavior and the identification of the drug diverter by using urine drug screening.

Biologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the "generic rule" valid for small chemical entities. In response, a dedicated regulation was issued in the European Union. It is based on the concept of "biological medicinal products similar to a biological reference product", or "biosimilars". This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature. This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.

Pharmacy Practice discusses the many factors impinging on daily practice and the place of pharmacy in the delivery of health care. The book goes beyond simply considering how pharmacy is practised and draws on a diverse range of disciplines, including sociology, social policy, psychology, anthropology, history and health economics, with each contributor bringing a unique perspective and insight into that practice. In this fully updated edition, the content and presentation have been thoroughly revised and new material added to reflect the many changes that have occurred in the last edition, particularly in pharmacy and health policy and professional regulation and development. The book provides the background and context for issues currently impacting professional practice and which will determine how pharmacy will develop in the future.

Discussing existing techniques, ongoing research, new approaches, and basic concepts in the treatment of nail diseases, Topical Nail Products and Ungual Drug Delivery summarizes the current knowledge and represents a jumping-off point for creating novel techniques of drug delivery across the nail. A growing area of pharmaceutical research, the search for efficient delivery techniques that can cross the nail barrier has yielded several effective strategies, brought together in this book. Topics Include Nail anatomy, physiology, diseases, and treatment Permeability of the nail plate Topical nail formulations Approaches to enhance ungual and trans-ungual drug delivery In vitro and in vivo models to evaluate topical nail formulations Nail sampling techniques Bioengineering of the nail Trans-ungual iontophoresis Pharmacokinetics of drugs in the nail apparatus Onychopharmacokinetics: proposed model insight Photodynamic therapy of nail diseases The nail as a surrogate for investigating drug use

The aim and scope of this book is to highlight the sources, isolation, characterization and applications of bioactive compounds from the marine environment and to discuss how marine bioactive compounds represent a major market application in food and other industries. It discusses sustainable marine resources of macroalgal origin and gives examples of bioactive compounds isolated from these and other resources, including marine by-product and fisheries waste streams. In addition, it looks at the importance of correct taxonomic characterization."

Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies.

Clinical pharmacology plays an important role in today's medicine. Due to the high sensitivity, selectivity, and affordability of a mass spectrometer (MS), the high performance liquid chromatography - mass spectrometry (LC-MS) analytical technique is widely used in the determination of drugs in human biological matrixes for clinical pharmacology. Specifically, LC-MS is used to analyze: anticancer drugs antidementia drugs antidepressant drugs antiepileptic drugs antifundal drug antimicrobial drugs antipsychotic drugs antiretroviral drugs anxiolytic/hypnotic drugs cardiac drugs drugs for addiction immunosuppressant drugs mood stabilizer drugs This book will primarily cover the various methods of validation for LC-MS techniques and applications used in modern clinical pharmacology.