Medicinsk kemi

New materials and manufacturing techniques are emerging with potential to address the challenges associated with the manufacture of pharmaceutical systems that will teach new tricks to old drugs. 3D printing (3DP) is a technique that can used for the manufacturing of dosage forms, and especially targeting paediatric and geriatric formulations, as permits the fabrication of high degrees of complexity with great reproducibility, in a fast and cost-effective fashion, and offers a new paradigm for the direct manufacture of personalised dosage forms. The book is covering the basics behind each additive manufacturing (AM) method, current applications in pharmaceutics for each 3DP method, and case studies (examples) from a teaching perspective, targeting undergraduate (UG) and postgraduate (PG) students. A unique to this book is the integration of studies based upon the use of different AM technologies, which designed to reinforce importance printing parameters and material considerations. The book includes case studies or multiple-choice questions (MCQs), which allow application of the content in a flipped-classroom.

Essential oils are simply the volatile oils of plants. These are concentrated liquids contain many terpenes, alkaloids and alcohols etc. Various compounds of essential oils have bioactive properties such as antimicrobial, anti-cancer, anti-diabetic, anti-viral and anti-fungal etc. This book describes the sources of essential oils, extraction and production method, characterizing tools, bioactivity, and various applications in the field of industries, daily usage, agriculture, health, and food.

This book provides readers a fundamental insight into the basic properties of the pharmaceutical agents used in the treatment of osteoporosis. It provides insight into mechanisms of action, updated information on clinical utility, and possible side effects associated with the use of these pharmaceutical agents. In particular, it highlights the use of two monoclonal antibodies romosozumab and denosumab in activating osteoblast differentiation and inhibiting osteoclasts. It also discusses two anabolic pharmaceutical agents, teriparatide and abaloparatide to treat osteoporosis. They have been shown to reduce the incidence of non-vertebral and vertebral fractures significantly after they were administered to patients daily as subcutaneous injections. The content of this book caters to researchers, scientists, and clinical practitioners who are interested in the treatment of osteoporosis using pharmaceutical agents.

There is a growing interest in unmet needs for the development of a new discipline in drug discovery and in university education on polypharmacology. However, there has not been a book with the comprehensive compilation of basic knowledge and advanced methodology that is needed. This book aims to meet the needs making Polypharmacology a new sub-discipline of Pharmacology, not only being a hot area of pharmacological research and education but also a new paradigm for drug discovery. It contains the contents covering the entire scope of Polypharmacology including systemic in-depth exposition of basic knowledge, novel concepts, innovative technologies, and translational and clinical applications by showcasing state-of-the-art strategies and step-by-step instructions of cutting-edge methods. The contents of this book targets broad readerships including scientists in pharmacology research and drug development, and university teachers and graduates in medical school or school of pharmacy.

This book explores the role of nanotechnology in the delivery of natural phytoconstituents and cosmeceuticals. It presents polymeric nanocarriers, lipid-based nanocarriers, metal/metal oxide nanocarriers, protein nanocarriers, and dendrimers for the delivery of phytoconstituents. Further, it focuses on the usage of phytocompounds in various cosmeceutical products and nano delivery technologies used in the delivery of various cosmeceuticals. Finally, the book reviews the toxicity issues of nanoparticles in the delivery of phytoconstituents and cosmeceuticals and regulatory aspects for clinical applications of nano phytomedicines. This book is helpful for academicians and researchers working in pharmaceutical sciences, nano science, material science, plant science, and cosmetic science.

Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.

The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process.The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms.Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process.Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations.Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up.Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource forthose involved in the pharmaceutical industry. Only book that is dedicated to pharmaceutical process engineering and scale-up; Contain numerous case studies for easy reference; Covers solid, liquid, and advanced dosage forms.

This book describes the emergence and recent advances in the design and development of rhodium complexes as therapeutic agents. Different classes of anticancer rhodium complexes with particular emphasis on ligands containing nitrogen-oxygen donor atoms are presented. Anticancer rhodium complexes of N-heterocyclic carbenes are described, while half-sandwich, heterobimetallic, and multinuclear rhodium complexes are discussed. Therapeutic applications of rhodium complexes beyond cancer such as antibacterial agents or antiviral agents are also analyzed, among others. Their mechanism of action is overviewed in detail, and the authors thoroughly comment on the challenges and future outlooks of research in the development of rhodium metallodrugs. This title highlights the important research carried out in the development of therapeutic rhodium complexes and is of great interest to graduates and researchers working in the area of rhodium-based therapeutic drugs.

This volume discusses hazardous environmental micropollutants, their impacts on human health, and possible means to mitigate their associated risks. The book features chapters that cover a variety of topics related to environmental micropollutants, which include dusts, infectious particles, heavy metals, organophosphates, atmospheric toxic organic micropollutants, fungal spores, pollutants from E-waste, antibiotic waste, and more. In addition impacts on human health and the environment, economic issues are addressed, with potential policy solutions offered. This work is timely, as hazardous micropollutants in soil, water and air are becoming more common, and this environmental contamination is leading to increasing instances of suboptimal human health outcomes. The book will be of interest to students and researchers in environmental pollution and remediation technology, microbiologists, and environmental regulators.  

This handbook covers the medicinal and chemical properties of Ayurvedic medicines, the plants that produce them and the currently known organic compounds that occur therein. It provides therapeutic attributes of each plant as well as indicates its potential for use as modern herbal or molecular drug. It combines the works of Ayurvedic folk medicine with modern pharmacology, botany, and chemistry in a singularly effective way. It also provides a useful standardization of classical Ayurvedic formulations. Consisting of numerous photographs of medicinal plants, this handbook will serve as an excellent reference work for chemists, botanists, pharmacists, and medical professionals.

This book reviews new promising drug targets for Neglected Tropical Diseases (NTDs), with a special focus on antiprotozoal drugs against trpyanosomatids Trypanosoma cruzi and Leishmania spp. The book offers a comprehensive overview of the most recent studied targets, and it outlines classical and new treatments and delivery strategies. Expert contributors describe new methods of analysis and bio-prospecting for new compounds, and provide a critical perspective of the translational process used in the research and development of new drug candidates.The book will appeal not only to researchers, students and professionals interested in drug development to protozoan diseases, but also to medicinal chemists in general.

Effective drug delivery systems are essential in maximizing the therapeutic effects of the drugs in question. This book thoroughly analyses recent technological advances in new, nanomaterial-based drug delivery systems for the diagnosis and treatment of various diseases. These systems also have diverse applications in pharmaceutical, biomedical, biomaterial, and biotechnological fields. This book explains the different types of nanocarriers currently in development and covers both therapeutic and theranostic applications of drug-loaded nanocarriers and nanomedicine.Clinical research professionals, industrial pharmaceutical scientists, and veteran drug delivery developers benefit from the unique structure of this book, making it essential for the drug delivery researcher. Students, research scholars, and industrial professionals alike benefit from the current technological advancements, regulatory aspects, and the history of discovery and development in the field of nanomedicine presented in this book.

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance.This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirementsof the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook¿s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.

Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book:Updates real-world CMC deficiency examples with current examples;Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance;Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.

Practical Pharmaceutics contains essential knowledge on the preparation, quality control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists and scientists working in hospitals, academia and industry throughout Europe, including practical examples as well as information on current GMP and GMP-based guidelines and EU-legislation. In this second edition all chapters have been updated with numerous new as well as didactically revised illustrations and tables. A completely new chapter about therapeutic proteins and Advanced Therapy Medicinal Products was added.From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers, students as well as professionals. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the required medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information for patients as well as caregivers about product care and how to maintain the quality of the product. The basic knowledge presented in the book will also be valuable for industrial pharmacists to remind and focus them on the application of the medicines manufactured.The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and in industry. Undergraduate as well as graduate pharmacy students will find knowledge presented in a coherent way and fully supported with relevant examples.Practical Pharmaceutics has become a reliable and recognised source for the acquisition of pharmaceutical-technological knowledge. The book is used in the curriculum of a number of international universities and schools of Pharmacy.

This volume focuses on the biomedical aspects of inorganic polyphosphates, a family of unique bio-inorganic polymers.In recent years, great advances have been made in understanding the development, metabolism, and physiological role of inorganic polyphosphates. These energy-rich polymers, which consist of long chains of phosphate units, are evolutionary old molecules. The acidocalcisomes, conserved organelles from bacteria to humans, as well as the mitochondria play a central role in polyphosphate production and storage. Polyphosphates have been assigned multiple functions, some of which are closely related to medically important processes, such as blood coagulation and fibrinolysis, energy metabolism, cell cycle regulation, apoptosis, chaperon function, microvascularization, stress response, neurodegeneration and aging. The development of bioinspired polyphosphate particles, in combination with suitable hydrogel-forming polymers enabled the development of new strategies in regenerative medicine, in particular for hard and soft tissue repair, but also in drug delivery and antimicrobial defense. This book not only highlights the basic research in this area, but also discusses possible applications. Therefore, it appeals to scientists working in cell biology, biochemistry, and biomedicine and practicioners alike.

As an academic or a small business owner, you will need to write grants at some point in your career. Writing them though is not enough, what you also need to know is how to win grants. Much has been written about writing grants, the mysterious special ability called ¿grantsmanship¿, so it occurred to me that there is a need to come at this differently and spill the beans. The difficulty in getting a grant, in particular an NIH grant like an R01 in the USA is often described, it is competitive and gets tougher every year. Your proposal therefore must stand out, it must connect with the reviewers. This is true for all types of grants, give the reviewer what they want always. But also, you need to connect to the program officer, the committee that ultimately makes funding decisions and you must take care of a myriad of other details outside of the main event which is describing the ¿science¿. This means you cannot rely on just out-writing the competition, it is more than that as you have to out-think, out-strategize and out-schmooze them. If you have been continually funded for decades that is terrific, but if you want to keep being funded there is no guarantee what got you there will keep you there. What was a hot technology 4-5 years ago is not the new thing anymore, you will need to do something different, but what? You therefore need to not only think about writing great grants, you need to put it into practice and win them. Having written and won grants from the NIH and DOD over the past 17 years (and longer by the time you read this) I possess a valuable perspective.Each grant and study section will be different. Whether a big or small grant it does not seem to make a difference the reviewers will critique your efforts, they may not like it, they may reject your ideas or they may love it. You have some small degree of control until the proposal leaves your hands or more correctly you click ¿submit¿. You will need to differentiate your grant from the hundreds of others in many ways, but you cannot change who you are, your history so how you describe yourself and team will also have an impact. You could spend hundreds of hours on your proposal or just a day and the outcome might still be the same. This small book is a summary of my own personal experiences and will provide some advice that will help you learn how to do a better job of winning grants.This book is written by a scientist who writes the grants and develops commercial products;Provides a unique perspective on what you need to write better grants;Teaches you how to continually win grants;This book provides examples from the authors own grant applications;The reader will be inspired to start a company to win small business grants.

This book provides an overview of Data Monitoring Committees(DMC) - what was done in the past, what is currently being done, and thoughts on improvements for the future. Previous works focused primarily on large cardiovascular studies (where DMCs originated more than 30 years ago) but updated references are needed that discuss smaller, more flexible studies in areas such as oncology. The authors have attended ~800 DMC meetings from ~200 distinct studies across all areas of clinical studies (oncology, rheumatology, rare diseases, cardiology, immunology, etc.) This wide range of expertise will be used, as well as the expertise that comes from working with virtually every large biotechnology and pharmaceutical company and CRO for DMC work. The reader of the book will know when DMCs are needed or helpful, how to form the DMC, how to work with external CROs and with sponsor teams and the DMC to create needed DMC outputs, how the DMC meetings are conducted, and - especially for DMC members - what are considerations within the Closed Session to review safety/efficacy outputs to assess risk/benefit to make appropriate recommendations that protect the patient safety and trial integrity.This is a practical hands-on book on how to decide if a DMC is necessary, how to form the DMC, how to expertly create the necessary materials for the DMC and have smooth running DMC meetings. There is no specialized training in school about how DMCs work - frequently people may have been in industry for many years without ever needing to work with a DMC. This book is the helpful reference for those new to these DMCs. The DMC work is critical to be correctly implemented as the impact of DMC activity on safeguarding the trial is so important.This book provides the following:Provides thorough instructions on the steps needed to form and implement a Data Monitoring Committee for clinical trial evaluation;Includes practical and hands-on information on DMC implementation;Discusses a wide range of clinical trial ¿ by phase and therapeutic area.

The purpose of this book is to highlight some of latest developments and applications of CRISPR, RNA, and DNA to treat diseases ranging from cancers to cardiovascular and degenerative disorders. It also features innovations of the delivery methods for nucleic acids ranging from nanodevices made from DNA and pseudo amino acids to viral vectors. This is an ideal book for academics, clinicians, and students interested in gene therapy.

Despite the critical importance of the cerebellum in brain function, the scientific community still lacks effective treatments for most cerebellar ataxias. This book provides a link between the pathogenesis and therapies of cerebellar ataxias while also providing a comprehensive assessment of the preclinical and clinical trials dedicated to cerebellar ataxias over the past 20 years of progress. This is the first book fully dedicated to the trials and therapies of these disorders. It is a truly authoritative and comprehensive reference, and comes at a time of major advances in genetic tools and neuroimaging assessments. The coverage begins by laying a foundation of the basic science of the cerebellum and ataxias, proceeds to discuss biomarkers and the tools of trials, offers guidelines on conducting trials, and then explores the full range of therapeutics and their trials, including gene therapy and cell transplantation. The authors are top experts on cerebellar research and the contributing authors have all made seminal contributions in the field.

This book provides a concise overview of recent advances in Pharmacokinetics (PK) and Pharmacodynamics (PD). The pharmacokinetics section covers the state of the art in Physiologically Based Pharmacokinetic (PBPK) modeling (Chapter 1) as well as the assessment of food effect on drug absorption using PBPK modeling (Chapter 2). Chapters 3 and 4 describe the recent development of Physiologically Based Finite Time Pharmacokinetic (PBFTPK) models and their applications to pharmacokinetic data. The pharmacodynamics section focuses on PK/PD modeling. Chapter 5 provides an overview of PK/PD modeling and simulation in clinical practice and studies. Chapter 6 deals with the subject/physiology variability issue encountered in PK/PD studies, while Chapter 7 reviews the influence of clinical pharmacology in the modernization of drug development and regulation. This book is an essential reference for pharmaceutical scientists.

This book provides the reader with a comprehensive understanding of oral biochemistry by explaining the role of basic biochemistry and dentistry concepts and identifying their metabolic processes of soft tissues that comprise oral and maxillofacial anatomy. The book also discusses how metabolic abnormalities are related to the development of oral diseases. Readers will gain a comprehensive perspective on a variety of oral conditions and related metabolic abnormalities. Individual chapters are focused on crucial topics such as enamel, dentine, saliva, fluoride, and many more. The importance of evidence-based explanation and case study details are also highlighted. Oral biochemistry is the first book to be devoted entirely to this area, and it will be of interest to researchers, students, and practitioners.

The disability-adjusted life year (DALY) is a generic measure of health effect that can be used in cost-effectiveness analysis as an alternative to the quality-adjusted life year (QALY). Infectious diseases are one of the major to cause significant losses of DALY and QALY. Human infectious diseases are disorders that are triggered by the micro-organisms such as bacteria, fungi, viruses, or parasites. The majority of such diseases are contagious and create a public health menace. There are several reasons why infectious diseases are deadly diseases, and one of the primary reasons is the drug resistance developed over time. Drug resistance-associated mutations are linked to increasing drug efflux, modifications of the drugs, or their targets. Every year, new drugs are being approved by FDA to treat infectious diseases. Nonetheless, the infectious diseases will undoubtedly persist as permanent and main threats to humanity for now and in the future.A total of four books are covered under the series of Infectious drug diseases.- Malarial drug delivery systems- Tubercular drug delivery systems- Viral drug delivery systems- Infectious disease drug delivery systemsInfectious diseases are the world¿s greatest killers that present one of the most significant health and security challenges. Humans have lived with emerging and re-emerging pathogens since before the documented history of civilization. The only determining fact today is - If the situation is ¿worse¿ or ¿better¿ than in past. The answer is probably ¿worse¿, may be due significant increase in human population, increased cross-continent mobility, imbalanced (stressed) life style, irregular food habits leading to compromised innate immunity and over or under practiced hygiene routine. When the incidence of such a disease in people increases over 20 years or threatens to increase, it is called an ¿emerging¿ disease, and a growing number have made watch lists andheadlines in nearly every country -like highly pathogenic H5N1 avian influenza, severe acute respiratory syndrome (SARS), Ebola virus, food- and waterborne illnesses, and a range of antimicrobial-resistant bacterial diseases TB. This book addresses current and new therapy developments in treating such infectious diseases, updates on finding new drugs, identification of innovative diagnostic methods, understanding of disease research models and clinical trials performances of new treatment modalities.Audiences from a broad range of groups, from researchers, academicians, and public health bodies to regulatory experts, can benefit from the compiled information to learn more about patient needs and current research advances in the field of infectious diseases and related research.

The first book in the newly created book series, Computer-Aided Drug Discovery and Design, focuses on the computational aspects of early drug discovery, drug target identification, and validation. It revises current classical paradigms in target and phenotypic-based drug design with still ingrained approximations and concepts and discusses the research in the new network approach concept that include kinetic selectivity and metabolic analysis.Many often-overlooked approximations and concepts in drug discovery are fully covered. Drug Target Selection and Validation includes both introductory sections and research-based sections to be of use to both students and research scientists in drug discovery, design, kinetics and metabolic analysis.  Pharmaceutical scientists, pharmaceutics, drug developers, pharmacologists, biomedical researchers in computer science, medicinal chemists, and precision medicine developers benefit from the information provided.  The book concludes with a chapter on chemical and structural databases.

This book provides the latest information on the significance of zebrafish as an ideal model for researching the biomedical field, with references. This book also focused on the evidence of zebrafish as a model in cardiovascular, neurologic, psychiatric and metabolic research. In addition, the book also includes the research carried out on zebrafish in hepatic, renal, ophthalmic, and ENT related areas. Contributed chapters come from the most prominent laboratories working in this field, which provides a unique perspective on zebrafish models from a wide spectrum of the research community. In addition, the book offers a detailed analysis of the most current research in the area for specific zebrafish models including specific research in the area of skin disorders, endocrine diseases, nutritional disorders, gastrointestinal, hematological disorders and cancer. The compilation of chapters in the volume culminates into a comprehensive and definitive text on zebrafish and its suitability for modeling various diseases, providing a critical resource on the potential attributes of the zebrafish as a pharmacological model. In terms of scope, this book is a useful tool for young researchers, professors and pharmaceutical scientists for understanding the significance of zebrafish as an emerging pharmacological model that can significantly aid in the process of drug discovery and development.