The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.

This book covers classic epidemiological designs that use a reference/control group, including case-control, case-cohort, nested case-control and variations of these designs, such as stratified and two-stage designs. It presents a unified view of these sampling designs as representations of an underlying cohort or target population of interest. This enables various extended designs to be introduced and analysed with a similar approach: extreme sampling on the outcome (extreme case-control design) or on the exposure (exposure-enriched, exposure-density, countermatched), designs that re-use prior controls and augmentation sampling designs. Further extensions exploit aggregate data for efficient cluster sampling, accommodate time-varying exposures and combine matched and unmatched controls. Self-controlled designs, including case-crossover, self-controlled case series and exposure-crossover, are also presented. The test-negative design for vaccine studies and the use of negative controls for bias assessment are introduced and discussed. This book is intended for graduate students in biostatistics, epidemiology and related disciplines, or for health researchers and data analysts interested in extending their knowledge of study design and data analysis skills. This book Bridges the gap between epidemiology and the more mathematically oriented biostatistics books. Assembles the wealth of epidemiological knowledge about observational study designs that is scattered over several decades of scientific publications. Illustrates the performance of methods in real research applications. Provides guidelines for implementation in standard software packages (Stata, R). Includes numerous exercises, covering simple mathematical proofs, consideration of proposed or published designs, and practical data analysis.

Research in the field of epilepsy will continue at a rapid pace, with the ultimate hope of curing many intractable epilepsy syndromes. Fully updated, this new edition is organized chronologically, from neonate through adolescence, and the handbook is the culmination of a group effort involving leading physicians and researchers whose contributions constitute a concise and practical reference for health professionals in training. Here the contributors review the recent flood of new information on the pathophysiology, genetics, and treatment of the various epilepsy syndromes and the volume is distilled into an easy-to-use guide. Fully updated text reviewing the latest research the pathophysiology, genetics, and treatment of the various epilepsy syndromes. Thorough, descriptions of the different syndromes commonly encountered in clinical practice across the pediatric range. Extensive resource section provided. Contributors describe why they chose each particular case, what they learned, and how it changed their practice. Access to a companion website, which offers digital graphics and videos on the topic

There is a great deal of contemporary interest in this topic and given this context, it is surprising that there are few texts around that cover this area. I think the proposal is perfectly placed to address this gap in the available literature in terms of an accessible ‘one-stop shop’ which researchers and scientists value as a broad overview of the contemporary literature and evidence-base. This book will interest practitioners and researchers in the food science and nutrition fields, and possibly others with an interest in the interaction between diet and health. There have been considerable advances in scientific techniques in the last few decades and these have been used to examine the composition and applications of traditional cures. Modern science has also seen the investigation of herbs, spices, and botanicals beyond their traditional usage. The evidence-based approach that the Editors propose is relatively rare for this type of topic. I think the market is already established for a book of this kind, it’s simply that there isn’t currently a book available to tap this market. I would believe this book would fulfill that role admirably.

Counterfeit drugs continue to infiltrate the drug market in the United States, causing illness and death. This book addresses this issue and examines the recent trends in drug counterfeiting over the past 5-10 years. The text shows perspectives from crime lab and toxicology lab personnel and academic researchers, and includes topics such as a history of cases and issues with counterfeit drugs, trends observed in forensic labs, instrumental methods and approaches used in detecting counterfeit medicines, and policy approaches for controlling counterfeit drugs. There is a focus on ways to reduce counterfeit drugs in the market, to help improve the health and safety of people all over the world. Features : Focuses on recent (5-10) year trends in counterfeit drugs and analysis. Shows perspectives from crime lab and toxicology lab personnel and academic researchers. Focuses on drugs seized by law enforcement and approaches to reducing counterfeit medicine in the market. Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue. Emphasizes the global impact of illegal medicines.

The authors show how the pharmaceutical industry faces the development of dermal drugs and provide the only book of its kind that describes how the industry develops and selects dermal drugs, complete with the challenges and opportunities of the field. Delivery of drugs through the skin has been an attractive and challenging area for research, and advances in modern technologies have resulted in a larger number of drugs being delivered transdermally, including conventional hydrophobic small molecule drugs, hydrophilic drugs and macromolecules. Offering the perspective from the industrial side of selection and development of drugs, the primary audience is geared towards the pharmaceutical industry but can also offer valuable information to clinicians, compounding pharmacists, and similarly pharmacy students. Dermal Drug Selection and Development covers the scientific gaps that exist in terms of dermal pharmacokinetics and the resulting uncertainty by clinicians when choosing a drug candidate.

The first chapter describes the oldest method of communication between living systems in Nature, the chemical language. Plants, due to their lack of mobility, have developed the most sophisticated way of chemical communication. Despite that many examples involve this chemical communication process - allelopathy, there is still a lack of information about specific allelochemicals released into the environment, their purpose, as well as in-depth studies on the chemistry underground. These findings are critical to gain a better understanding of the role of these compounds and open up a wide range of possibilities and applications, especially in agriculture and phytomedicine. The most relevant aspects regarding the chemical language of plants, namely, kind of allelochemicals have been investigated, as well as their releasing mechanisms and their purpose, are described in this chapter. The second chapter is focused on the natural products obtained from Hypericum L., a genus of the family Hypericaceae within the dicotyledones. Hypericum has been valued for its important biological and chemical properties and its use in the treatment of depression and as an antibacterial has been well documented in primary literature and ethnobotanical reports. The present contribution gives a comprehensive summary of the chemical constituents and biological effects of this genus. A comprehensive account of the chemical constituents including phloroglucinol derivatives, xanthones, dianthrones, and flavonoids is included. These compounds show a diverse range of biological activities that include antimicrobial, cytotoxic, antidepressant-like, and antinociceptive effects. The third chapter addresses microtubule stabilizers, which are a mainstay in the treatment of many solid cancers and are often used in combination with molecularly targeted anticancer agents and immunotherapeutics. The taccalonolides are a unique class of such microtubule stabilizers isolated from plants of Tacca species that circumvent clinically relevant mechanisms of drug resistance. Although initial reports suggested that the microtubule stabilizing activity of the taccalonolides is independent of direct tubulin binding, additional studies have found that potent C-22,23 epoxidated taccalonolides covalently bind the Aspartate 226 residue of -tubulin and that this interaction is critical for their microtubule stabilizing activity. Some taccalonolides have demonstrated in vivo antitumor efficacy in drug-resistant tumor models with exquisite potency and long-lasting antitumor efficacy as a result of their irreversible target engagement. The recent identification of a site on the taccalonolide scaffold that is amenable to modification has provided evidence of the specificity of the taccalonolide-tubulin interaction and the opportunity to further optimize the targeted delivery of the taccalonolides to further improve their anticancer efficacy and potential for clinical development.

This book is the first of two volumes that offer a comprehensive, up-to-date account of current knowledge regarding high-density lipoprotein (HDL), the changes that occur in HDL under different conditions, the clinical applications of HDL, and means of enhancing HDL functionality. HDL comprises a diverse group of lipoproteins and its composition and metabolism are dynamic. In this volume, the focus is on the changes observed in HDL under different health statuses, with particular attention to the functional and structural correlations of HDL and apolipoprotein A-1. The impacts of a wide variety of factors on HDL are examined in depth, covering, for example, diet, exercise, smoking, age, diverse diseases, and different forms of environmental pollution. It has long been known that HDL has anti-atherosclerotic and antidiabetic properties, and more recently its anti-aging activities have been recognized. These benefits of HDL are highly dependent on its lipids, proteins, apolipoproteins, and enzymes, and specifically their composition and ratios. In documenting the latest knowledge in this field, this volume will be of interest to both researchers and clinicians.

This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16-18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applications in drug discovery and CMC to biomarkers, clinical trials, and statistical programming. All contributions feature original research, and together they cover the full spectrum of pharmaceutical R&D - with a special focus on emergent topics such as biosimilarity, bioequivalence, clinical trial design, and subgroup identification. Founded in 1978, the MBSW has provided a forum for statisticians to share knowledge, research, and applications on key statistical topics in pharmaceutical R&D for almost forty years, with the 2016 conference theme being "The Power and 3 I's of Statistics: Innovation, Impact and Integrity." The papers gathered here will be of interest to all researchers whose work involves the quantitative aspects of pharmaceutical research and development, including pharmaceutical statisticians who want to keep up-to-date with the latest trends, as well as academic statistics researchers looking for areas of application.

This book proposes the importance of new systems of drug design and delivery based on cancer pathophysiology in addition to cancer molecular and cellular biology. The current studies based on molecular and cellular biology while ignoring pathophysiology and pharmacology may be leading the development of antitumor drugs in the wrong direction and wasting a lot of money. Although there have been numerous reports of genetic and phenotypic changes in tumors, a large body of pathological and clinical evidence supports the conclusion that there are no pivotal changes in tumor cells that distinguish them consistently and reliably from normal dividing cells. Unlike using antibiotics against bacterial infection, therefore, anticancer agents (ACAs) need to be delivered selectively to tumor tissues and should be kept there long enough to reproduce the concentrations they reach in the Petri dish, which is a closed space where the cytocidal effects of any anticancer agents (ACAs) including molecular targeting agents are very strong. In the body, however, administered ACAs are cleared with the passage of time. Furthermore, most human cancers possess abundant stroma that hinders the penetration of drugs into the tumor microenvironment. Therefore, to overcome these difficulties, novel drug delivery systems have been designed, such as nanoparticles and ACA conjugated antibodies to stromal components and to cancer cell surface antigens. These advances are described in this book after the first section, which describes core features of the pathophysiology of the cancer microenvironment, on which these new developments are based.

This book highlights the recent advances of thermodynamics and biophysics in drug delivery nanosystems and in biomedical nanodevices. The up-to-date book provides an in-depth knowledge of bio-inspired nanotechnological systems for pharmaceutical applications. Biophysics and thermodynamics, supported by mathematics, are the locomotive by which the drug transportation and the targeting processes will be achieved under the light of the modern pharmacotherapy. They are considered as scientific tools that promote the understanding of physicochemical and thermotropic functionality and behavior of artificial cell membranes and structures like nanoparticulate systems. Therefore, this book focusses on new aspects of biophysics and thermodynamics as important elements for evaluating biomedical nanosystems, and it correlates their physicochemical, biophysical and thermodynamical behaviour with those of a living organism. In 2018, Prof. Demetzos was honored with an award by the Order of Sciences of the Academy of Athens for his scientific contribution in Pharmaceutical Nanotechnology.

This up-to-date reference book discusses the synthesis, production, and application of various microbial enzymes and metabolites for health. Microorganisms like bacteria (lactic acid bacteria, Bacillus species), yeasts, and filamentous fungi have been globally exploited for their biotechnological applications. This book discusses ways to use them commercially. Chapters include the production of fibrinolytic enzymes, microbial lipases, bacteriocin production by lactic acid bacteria, and bioactives produced. It also covers microbial synthesis of alkaloids, terpenoids, and steroids. The book is useful for researchers, academicians, and industry experts in microbiology and biotechnology.

The microneedle field has been expanding exponentially with innovative designs and various applications, thus capturing the interest of academic industry and regulatory sectors. Microneedles: The Future of Drug Delivery equips readers with a comprehensive understanding of microneedles; from percutaneous absorption to microneedles production, characterization, applications in drug delivery and diagnosis, to practical perspectives on the development, manufacturing, regulatory issues, and commercialization of microneedles. This book is written by a single author and thus provides complex information in a simple, elegant and cohesive style. The book is intended for graduate students, researchers, scientists and engineers working in the pharmaceutical, medical, cosmeceutical, and biotechnology industry.

This book is the second of two volumes that offer a comprehensive, up-to-date account of current knowledge regarding high-density lipoprotein (HDL), the changes that occur in HDL under different conditions, the clinical applications of HDL, and means of enhancing HDL functionality. In this volume, the focus is on the improvement of HDL, enhancement of its functionality, and the use of HDL for therapeutic purposes. In the first section, up-to-date information is provided on such topics as the tumor regression-promoting and antidiabetic activities of reconstituted HDL containing V156K apolipoprotein A-I, the enhancement of HDL effects by high doses of vitamin C, the benefits derived from incorporation of growth hormones 1 and 2 into rHDL, and the biological functions of omega-3 linolenic acid in rHDL. The enhancement of HDL functionality by policosanol and the resultant benefits are thoroughly examined in a separate section. Readers will also find the latest information on clinical applications of HDL. Here, specific topics include the enhancement of adenoviral gene delivery and the delivery of rapamycin. In documenting the latest knowledge in this field, this volume will be of interest to both researchers and clinicians.

* provides an in-depth discussion of recent advances in sterilization * identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions * explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results * New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture.

Intelligent Nanomaterials for Drug Delivery Applications discusses intelligent nanomaterials with a particular focus on commercial and premarket tools. The book looks at the applications of intelligent nanomaterials within the field of medicine and discusses their future role. This includes the use of intelligent nanomaterials for drugs used in cardiovascular and cancer treatments and examines the promising market of nanoparticles for biomedical and biosensing applications. This resource will be of great interest to scientists and researchers involved in multiple disciplines, including micro- and nano-engineering, bionanotechnology, biomedical engineering, and nanomedicine, as well as pharmaceutical and biomedical industries.

This second edition further develops the principles of applying kinetic principles to drug metabolizing enzymes and transporters. Chapters are divided into six sections detailing fundamental principles of enzyme kinetics, enzyme and transporter structures, highlighting specific oxidative and conjugative drug metabolizing enzymes and drug transporters, modeling approaches for drug metabolizing enzymes and transporters, understanding of variability both experimental and interindividual (pharmacogenomic), and expanded case studies that provide real life examples of applying these principles. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, in some cases step-by-step instructions with readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls with extensive cross referencing to assist in learning. Authoritative and fully updated, Enzyme Kinetics in Drug Metabolism: Fundamentals and Applications, Second Edition serves as a practical teaching tool for novice and advanced scientists interested in the fundamental concepts.

Nanomaterials is an encouraging field for scientists and researchers due to its numerous applications in different fields such as medicine, energy, pharmaceutical, environmental science, agricultural food science and technology. Researchers are shifting towards the synthesis of nanoparticles using various plant systems.

The Place of Heterogeneous Catalysis in the Chirality Field: Commercial Outlook for Chirality: Quo Vadis? (E. Polastro). Strategies for Asymmetric Synthesis: What Is the Role of Heterogeneous Catalysis? (L. Ghosez). Homogeneous Enantioselective Catalysis (H. Brunner). Hydrogenation Systems: Toward a Better Understanding: Enantiodifferentiating Hydrogenation of Simple Alkanones with Asymmetrically Modified Heterogeneous Catalyst (T. Osawa et al.). Enantiodifferentiating Hydrogenation of 2Butanone: Distinction between CH3 and C2H5 with a Modified Nickel Catalyst (T. Harada, T. Osawa). Asymmetric Hydrogenation of Ethyl Pyruvate Using Ptcontaining Zeolites Modified with ()Cinchonidine (W. Reschetilowski et al.). Hydrogenation Systems: Broadening the Scope: Enantio and Diastereoselective Reduction of Disubstituted Aromatics (K. Nasar et al.). Heterogeneous Asymmetric Catalysis with C2 Symmetric Aminemodified Rhodium/Silica (P. Gamez). More Advanced Reactions: Chiral Dioxomolybdenum Complexes Anchored to Modified USYZeolites: Application to Selective Epoxidation of Olefins (A. Corma et al.). Effect of Sulfoxide Loading on the Selectivity and Activity of Zeolite Y for Dehydration Reactions (D. Bethell et al.). 11 additional articles. Index.

Dendrimers are repeatedly branched and roughly spherical large molecules. They can be used in various medical applications, such as anticancer polymeric nanomedicines and nanocarriers, gene carriers and vectors in gene delivery, contrast agents for molecular imaging and vaccines against infectious diseases and cancer. The highly branched, multivalent nature and molecular architecture of dendrimers make them ideal tools for a variety of tissue engineering applications. This book describes different categories of dendrimers, their biomedical and physico-chemical applications as well as convergent and divergent syntheses, click chemistry and ligation strategies. It is a rich source of information for researchers in biochemistry and pharmacology working on drug development as well as for organic chemists who are engaged in synthesis of dendrimers.

A comprehensive review of the challenges that exist in patient accessibility to advanced therapy medicinal products (ATMPs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialisation. Specfically, we investigated how COVID-19 has impacted the RMs industry by elaborating on the disruptions it caused but also the new opportunities it brought. The ultimate goal of this work is to make strategic recommendations for manufacturers and decisions-markers on effective strategies to address the above obstacles and facilitate patient access to promising regenerative medicines. Features : Regenerative medicine (RM) is an emerging interdisciplinary field aiming to replace or regenerate human cells, tissues, or organs in order to restore normal functions. Regenerative medicine holds the promise of revolutionising treatment in the 21st century. RMs bring new hope for some previously untreatable diseases, as well as holding promise for the treatment of common chronic diseases. Rapid advancements in biotechnology and improved understanding of disease pathophysiology have attracted tremendous interests in the development of RMs. Discusses the high cost of RMs which may challenge the sustainability of healthcare insurers (public and private).

A comprehensive review of the challenges that exist in patient accessibility to advanced therapy medicinal products (ATMPs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialisation. Specfically, we investigated how COVID-19 has impacted the RMs industry by elaborating on the disruptions it caused but also the new opportunities it brought. The ultimate goal of this work is to make strategic recommendations for manufacturers and decisions-markers on effective strategies to address the above obstacles and facilitate patient access to promising regenerative medicines. Features : Regenerative medicine (RM) is an emerging interdisciplinary field aiming to replace or regenerate human cells, tissues, or organs in order to restore normal functions. Regenerative medicine holds the promise of revolutionising treatment in the 21st century. RMs bring new hope for some previously untreatable diseases, as well as holding promise for the treatment of common chronic diseases. Rapid advancements in biotechnology and improved understanding of disease pathophysiology have attracted tremendous interests in the development of RMs. Discusses the high cost of RMs which may challenge the sustainability of healthcare insurers (public and private).