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This work brigdges the compartmentalized undergraduate organic and biochemistry and biology subjects to the pharmacology and the clinical areas a modern pharmacy practice requires. The changes and constantly increasing responsibilities of today's pharmacist have dictated a restructuring of the pharmacy curriculum, including individual course content. This book reflects and addresses these developments. This is a well-written work that covers most major areas of pharmaceutical research. The text is presented in a logical and concise fashion being divided into chapters based upon therapeutic topic. This makes the work very useful for teaching a course in medicinal chemistry since therapeutic areas can be separately covered without having to make use of the entire book which overall contains a tremendous amount of information. This book is a significant contribution to understanding what medicinal chemistry is and how this science is used to develop new therapeutic agents.
Dr. Jean Huxsoll and a team of distinguished biotechnology industry experts from the U.S. and Europe offer a wealth of practical guidelines to designing, implementing, and managing QA systems to assure that biopharmaceutical products meet standards for safety purity, and potency. Quality Assurance for Biopharmaceuticals covers all important theoretical and practical concerns, including detailed guidelines to meeting GMP compliance; quality assurance of production; quality assurance of analytical methods; advanced documentation, sampling, and validation techniques; comprehensive coverage of regulatory issues in the U.S., Europe, and Japan; and much more.
Long acting injections and implants improve therapy, enhance patient compliance, improve dosing convenience, and are the most appropriate formulation choice for drugs that undergo extensive first pass metabolism or that exhibit poor oral bioavailability. An intriguing variety of technologies have been developed to provide long acting injections and implants. Many considerations need to go into the design of these systems in order to translate a concept from the lab bench to actual therapy for a patient. This book surveys and summarizes the field.
Topics covered in "Long Acting Injections and Implants" include the historical development of the field, drugs, diseases and clinical applications for long acting injections and implants, anatomy and physiology for these systems, specific injectable technologies (including lipophilic solutions, aqueous suspensions, microspheres, liposomes, in situ forming depots and self-assembling lipid formulations), specific implantable technologies (including osmotic implants, drug eluting stents and microfabricated systems), peptide, protein and vaccine delivery, sterilization, drug release testing and regulatory aspects of long acting injections and implants.
This volume provides essential information for experienced development professionals but was also written to be useful for scientists just beginning work in the field and for others who need an understanding of long acting injections and implants. This book will also be ideal as a graduate textbook."
Written by an author with more than 40 years of teaching experience in the field, Experiments in Pharmaceutical Chemistry, Second Edition responds to a critical classroom need for material on directed laboratory investigations in biological and pharmaceutical chemistry. This new edition supplies 75 experiments, expanding the range of topics to 22 major areas of pharmaceutical chemistry. These include biochemical groups, botanical classes important to pharmacy, and major drug classifications:
Sections contain introductions to basic concepts underlying the fields addressed and a specific bibliography relating to each field. Each experiment provides detailed instructions in a user-friendly format, and can be carried out, in most cases, without the need for expensive instrumentation. This comprehensive laboratory manual offers much-needed instructional material for teaching laboratory classes in pharmaceutical chemistry. The breadth of subject matter covered provides a variety of choices for structuring a laboratory course.
Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals. Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities.
This book covers a wide range of topics concerning human tear based science, starting from basics such as the normal composition of tears and moving up to novel disease detection platforms. The entire approach is pioneering, as tears are beginning to be recognized as the most invaluable non-invasive tool in diagnostics. Interestingly, the concept is not restricted to ocular diseases: In recent years, tear diagnostics is increasingly being tapped even for cancer detection. Hopefully, non-invasive tear diagnostics will eventually replace today's invasive disease detection and monitoring techniques. Previous literature on tear diagnostics has been restricted to scientific journal articles, most of which dealt with a single tear constituent, such as a protein. This book offers a far more comprehensive and handy `reference guide,' presenting both basic and advanced information and data. Accordingly, it will be useful for researchers in academia and the pharmaceutical industry, as well as healthcare professionals and diagnostic kit developers.
The development of innovative drugs is becoming more difficult while relying on empirical approaches. This inspired all major pharmaceutical companies to pursue alternative model-based paradigms. The key question is: How to find innovative compounds and, subsequently, appropriate dosage regimens?
Written from the industry perspective and based on many years of experience, this book offers:
- Concepts for creation of drug-disease models, introduced and supplemented with extensive MATLAB programs
- Guidance for exploration and modification of these programs to enhance the understanding of key principles
- Usage of differential equations to pharmacokinetic, pharmacodynamic and (patho-) physiologic problems thereby acknowledging their dynamic nature
- A range of topics from single exponential decay to adaptive dosing, from single subject exploration to clinical trial simulation, and from empirical to mechanistic disease modeling.
Students with an undergraduate mathematical background or equivalent education, interest in life sciences and skills in a high-level programming language such as MATLAB, are encouraged to engage in model-based pharmaceutical research and development.
This book continues to be the definitive reference on drug metabolism with an emphasis on new scientific and regulatory developments. It has been updated based on developments that have occurred in the last 5 years, with new chapters on large molecules disposition, stereo-selectivity in drug metabolism, drug transporters and metabolic activation of drugs. Some chapters have been prepared by new authors who have emerged as subject area experts in the decade that has passed since publication of the first edition.
Infectious diseases caused by viruses, parasites, bacteria, and fungi are the number one cause of death worldwide. Although new technologies have improved diagnosis of infectious diseases, the efficacy of all known current anti-infective agents is threatened by the spread of drug-resistant forms of the pathogens. Hence, there remains an urgent need to develop anti-infective agents that target drug-resistant pathogens. In Silico Models for Drug Discovery presents a comprehensive look at the role in silico models play in understanding infectious diseases and in developing novel therapeutics to treat them. Written by leading experts in the field, chapters cover topics such as techniques to derive novel antimicrobial targets, methods of interpreting polypharmacology-based drug target networks, and molecular dynamics techniques used to compute binding energies of drugs to their target proteins, to name a few. Written in the successful Methods in Molecular Biology (TM) series or in review article format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and easily accessible, In Silico Models for Drug Discovery seeks to serve both professionals and novices involved in the study and treatment of infectious diseases.
Sets forth the history, state of the science, and future directions of drug discovery
Edited by Jie Jack Li and Nobel laureate E. J. Corey, two leading pioneers in drug discovery and medicinal chemistry, this book synthesizes great moments in history, the current state of the science, and future directions of drug discovery into one expertly written and organized work. Exploring all major therapeutic areas, the book introduces readers to all facets and phases of drug discovery, including target selection, biological testing, drug metabolism, and computer-assisted drug design.
"Drug Discovery" features chapters written by an international team of pharmaceutical and medicinal chemists. Contributions are based on a thorough review of the current literature as well as the authors' firsthand laboratory experience in drug discovery. The book begins with the history of drug discovery, describing groundbreaking moments in the field. Next, it covers such topics as: Target identification and validationDrug metabolism and pharmacokineticsCentral nervous system drugsIn vitro and in vivo assaysCardiovascular drugsCancer drugs
Each chapter features a case study, helping readers understand how science is put into practice throughout all phases of drug discovery. References at the end of each chapter serve as a gateway to groundbreaking original research studies and reviews in the field.
"Drug Discovery" is ideal for newcomers to medicinal chemistry and drug discovery, providing a comprehensive overview of the field. Veterans in the field will also benefit from the perspectives of leading international experts in all aspects of drug discovery.
The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship.
This book is devoted to the graphics of patient data: good graphs enabling straight-forward and intuitive interpretation, efficient creation, and straightforward interpretation. We focus on easy access to graphics of patient data: the intention is to show a large variety of graphs for different phases of drug development, together with a description of what the graph shows, what type of data it uses, and what options there are. The main aim is to provide inspiration in form of a graphics cookbook. Many graphs provide creative ideas about what can be done. The book is not intended to be technical. It introduces general principles of good visualization to make readers understand the concepts, but the main focus is on the creativity and usefulness: readers are enabled to browse through the book to get ideas of how their own data can be analyzed graphically.
For additional information visit Editor s companion website: http: //www.elmo.ch/doc/life-science-graphics/
Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations-many of which will be nanoparticulates-can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.
This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation's knowledge assets can provide a path towards business excellence.
A comprehensive look at current drug discovery and development methods--and the roadmap for the future
Providing both understanding and guidance in characterizing potential drugs and their production and synthesis, "Development of Therapeutic Agents Handbook" gives professionals a basic tool to facilitate research and development within this challenging process. This comprehensive text brings together, in one resource, a compendium of concepts, approaches, methodologies, and limitations that need to be considered in the formulation of therapeutic agents across a range of therapeutic fields. Both a reference and a call to action for the pharmaceutical industry, "Development of Therapeutic Agents Handbook" examines recent innovations taking shape in the various medical disciplines involved in drug discovery, and shows why these advances need to be embraced universally among researchers to improve their solution strategies. Additional subject matter includes:
Extensive coverage and in-depth look into novel treatments and therapeutics
Discussion of hot topics like new drugs and nutraceuticals, the discovery and development of vaccines, cancer therapeutics, and market overviews
Coverage of therapeutic drug development for specific disease areas, such as cardiology, oncology, breast cancer, and kidney diseases
As research in biology, chemistry, medicine, and technology rapidly progresses, it is becoming increasingly important for medical researchers to maintain an up-to-date knowledge base of emerging trends directing promising new therapies. "Development of Therapeutic Agents Handbook" serves this purpose, acting as both a one-stop reference rich in valid science, and a tool to carve out new pathways in the pursuit of bringing safer and more effective drugs to the marketplace.
It is increasingly recognized that various transporter proteins are expressed throughout the body and determine absorption, tissue distribution, biliary and renal elimination of endogenous compounds and drugs and drug effects. This book will give an overview on the transporter families which are most important for drug therapy. Most chapters will focus on one transporter family highlighting tissue expression, substrates, inhibitors, knock-out mouse models and clinical studies.
The 4th edition of Drug Interactions in Infectious Diseases is being split into two separate volumes - "Mechanisms and Models of Drug Interactions" and "Antimicrobial Drug Interactions". This volume, "Mechanisms and Models of Drug Interactions," delivers a text that enhances clinical knowledge of the complex mechanisms, risks, and consequences of drug interactions associated with antimicrobials, infection, and inflammation. The book provides a comprehensive review of basic clinical pharmacology with a focus on metabolism and transporter-mediated drug interactions. The chapters address materials that cannot be retrieved easily in the medical literature, including materials focused on the complex interrelationship of acute infection, inflammation, and the risk of drug interactions in the Drug-Cytokine chapter. The Food-Drug and Herb-Drug interactions chapters remain definitive resources. A new chapter on in vitro modeling of drug interactions is included along with updates on design and data analysis of clinical drug interaction studies. Authoritative discussion of models for regulatory decision-making on drug-drug interactions provides the necessary framework to aid antimicrobial drug development. This concise review of the mechanisms and models of drug interactions provides important insights to health care practitioners as well as scientists in drug development.
Contents: Gerard Jaouen, Nils Metzler-Nolte : Introduction ; Stephane GIBAUD and Gerard JAOUEN: Arsenic - based drugs: from Fowler's solution to modern anticancer chemotherapy; Ana M. Pizarro, Abraha Habtemariam and Peter J. Sadler : Activation Mechanisms for Organometallic Anticancer Complexes; Angela Casini, Christian G. Hartinger, Alexey A. Nazarov, Paul J. Dyson : Organometallic antitumour agents with alternative modes of action; Elizabeth A. Hillard, Anne Vessieres, Gerard Jaouen : Ferrocene functionalized endocrine modulators for the treatment of cancer; Megan Hogan and Matthias Tacke : Titanocenes - Cytotoxic and Anti-Angiogenic Chemotherapy Against Advanced Renal-Cell Cancer; Seann P. Mulcahy and Eric Meggers : Organometallics as Structural Scaffolds for Enzyme Inhibitor Design; Christophe Biot and Daniel Dive : Bioorganometallic Chemistry and Malaria; Nils Metzler-Nolte : Biomedical applications of organometal-peptide conjugates; Roger Alberto : Organometallic Radiopharmaceuticals; Brian E. Mann : Carbon Monoxide - an essential signaling molecule.
Ten years ago, bell hooks astonished readers with Teaching to Transgress: Education as the Practice of Freedom. Now comes Teaching Community: A Pedagogy of Hope - a powerful, visionary work that will enrich our teaching and our lives. Combining critical thinking about education with autobiographical narratives, hooks invites readers to extend the discourse of race, gender, class and nationality beyond the classroom into everyday situations of learning. bell hooks writes candidly about her own experiences. Teaching, she explains, can happen anywhere, any time - not just in college classrooms but in churches, in bookstores, in homes where people get together to share ideas that affect their daily lives. In Teaching Community bell hooks seeks to theorize from the place of the positive, looking at what works. Writing about struggles to end racism and white supremacy, she makes the useful point that "No one is born a racist. Everyone makes a choice." Teaching Community tells us how we can choose to end racism and create a beloved community. hooks looks at many issues-among them, spirituality in the classroom, white people looking to end racism, and erotic relationships between professors and students. Spirit, struggle, service, love, the ideals of shared knowledge and shared learning - these values motivate progressive social change. Teachers of vision know that democratic education can never be confined to a classroom. Teaching - so often undervalued in our society -- can be a joyous and inclusive activity. bell hooks shows the way. "When teachers teach with love, combining care, commitment, knowledge, responsibility, respect, and trust, we are often able to enter the classroom and go straight to the heart of the matter, which is knowing what to do on any given day to create the best climate for learning."
This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-a-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.
Natural Product Chemistry for Drug Discovery provides a comprehensive summary of where natural product chemistry is today in drug discovery. The book covers emerging technologies and case studies and is a source of up-to-date information on the topical subject of natural products. The authors, all experts in their respective fields, provide compelling arguments as to why naturel products should be considered important tools in the drug discovery process. The book will appeal across the board from scientists to professionals, postgraduates and industrial chemists. The case studies selected for inclusion highlight recently marketed drugs and development candidates that have been derived from natural products. These 'real-life' examples show how new technologies, such as advances in screening, isolation, dereplication and prefractionation, have significantly enhanced the discovery process.
70-chapter authoritative reference that covers therapeutic
monoclonal antibody discovery, development, and clinical
applications while incorporating principles, experimental data, and
methodologies. First book to address the discovery and development
of antibody therapeutics in their entirety.Most chapters contain
experimental data to illustrate the principles described in
them.Authors provide detailed methodologies that readers can take
away with them and use in their own laboratories
This unique book is the only one to discuss various new techniques developed to enhance the application of nanoparticulate drug delivery systems using surface modification of nanoparticles. The understanding of the surface characteristics nano-particles is growing significantly with the advent of new analytical techniques. Polymer chemistry is contributing to the development of many new versatile polymers which have abilities to accommodate many different, very reactive chemical groups, and can be used as a diagnostic tool, for better targeting, for more effective therapeutic results as well as for reducing the toxic and side effects of the drugs. Surface modification of such polymeric nanoparticles has been found by many scientists to enhance the application of nanoparticles and also allows the nano particles to carry specific drug molecule and disease /tumor specific antibodies which refine and improve drug delivery. Surface Modification of Nanoparticles for Targeted Drug Delivery is a collection essential information with various applications of surface modification of nanoparticles and their disease specific applications for therapeutic purposes.
In my professional career as a pharmaceutical scientist, I have been involved with severalaspectsofthe drugdevelopmentprocessfrompre-INDto commercialization and, somehow, I usually found myself coming back to a stability-related issue. The stability area seemed to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues were the same.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment, an understandingof regulations, a knowledgeof science, a graspof compliance, and an appreciation of common practices. Sinceearly2000, Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand I struggled to ?nd good, concise, practical resources, one of which I could just hand to a new scientist who wishes to gain a greater understanding of stability sciences. In addition, I encountered the same questions posted over and over on different stability best practices discussion forums. As a book lover, I also have a good collection of technical books. Unfor- nately, most of the stability related volumes are outdated. Many of these materials are theoretical and do not contain much practical information. I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changingrapidlywhileregulatoryagenciesareworkingcloselywiththepharmac- tical industryto accommodatethese changes;however, thefundamentalinformation continues to remain quite the same, just as current Good Manufacturing Practices (cGMP) continue to be the standard industry practice. Therefore, I hoped to ass- ble a practical handbook to ?ll this v
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